TVT Registry Provides Picture of TAVR Risk Factors, 1-Year Outcomes
Most elderly patients with comorbidities who have undergone TAVR in the United States outside of clinical trials have acceptable 1-year mortality and stroke rates, according to a report from the Transcatheter Valve Therapy (TVT) Registry published in the March 10, 2015, issue of the Journal of the American Medical Association. However, among very high-risk patients, mortality can be greater than 50%.
The findings were first presented in March 2014 at the American College of Cardiology/i2 Scientific Session in Washington, DC.
David Holmes Jr, MD, of the Mayo Clinic (Rochester, MN), and colleagues looked at 1-year outcomes for 12,182 patients (median age 84 years; 52% female) who underwent TAVR between November 2011 and June 2013 at 299 US hospitals. All were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry, which collects comprehensive data on virtually all patients in the United States undergoing TAVR with the Sapien valve (Edwards Lifesciences). The study merged data from the registry with Centers for Medicare and Medicaid Services (CMS) administrative claims data.
The registry was developed in response to a CMS mandate following the National Coverage Decision in 2012 to capture all patients in the US undergoing commercial TAVR procedures.
Median STS Predicted Risk of Operative Mortality (STS PROM) score was 7.1%, with 30.8% of patients falling in the 8-15% range and 11.9% with a risk greater than 15%. The rate of comorbidities was high, and approximately 40% of patients had slow gait indicative of frailty. Additionally, nontransfemoral access was required in 43.6%.
The majority of patients (59.8%) were discharged directly home after TAVR. At 30 days, 7.0% had died and 2.5% had suffered a stroke. By 6 months, mortality had increased to 16.7%.
About one-quarter of patients were rehospitalized once within 1 year, 12.5% twice, and 11.6% 3 or more times. The most common reason for readmission was a composite of stroke, heart failure, or repeat aortic valve intervention (18.6%), which was driven by heart failure (14.3%).
At 1 year, mortality was 23.7%, stroke was 4.1%, and the composite of mortality and stroke was 26.0%.
On multivariate analysis, advancing age, male sex, several comorbidities and nontransfemoral access were among the factors associated with greater 1-year mortality (table 1).
In exploratory analysis of 77 patients aged 85 to 94 years who were undergoing dialysis and had an STS PROM score greater than 15%, the 1-year mortality rate was 53.5%.
Importantly, analysis of baseline variables identified only female sex as being associated with increased stroke risk at 1 year (HR 1.40; 95% CI 1.15-1.71).
Significance of Lower STS Scores Unclear
Of note is that the current study had a lower median STS PROM score than did either the PARTNER A or B trials (11.8% and 11.2%, respectively). Whether that “represents a broadening in selection criteria to include lower-risk patients or whether that specific score may actually underestimate surgical risk as determined by experienced cardiovascular surgeons is unknown,” they write.
Additionally, they say, the higher mortality rate seen in the small subsets with advanced age and comorbidities suggests that “[i]t may be possible to identify patients who may not benefit from this procedure and who should be counseled accordingly.” However, despite the high mortality risk, they point out, “quality of life and the potential to decrease rehospitalizations for congestive heart failure are important additional issues to be considered.”
Dr. Holmes and colleagues suggest that the higher stroke risk for women compared with men may be related to other unmeasured comorbidities in women such as ascending aortic atheroma, or the use of large delivery sheaths.
A Critical Yardstick
Ted Feldman, MD, of NorthShore University HealthSystem (Evanston, Illinois), said the TVT Registry data are of “tremendous help” to individual practitioners.
“We work in our own little universe day to day, and this registry is a really critical yardstick for American practitioners to see whether their own experience is aligned with what is now a broad experience in a large number of patients,” he said in a telephone interview with TCTMD. “What we see at the end of 2013, as reflected in this registry, is a pretty large number of patients with generally very good results.”
Furthermore, Dr. Feldman said the diminishing STS risk score suggests that patient selection has evolved.
“They still look like high-risk patients, but the lower STS risk attests to careful selection, and the self-reported low stroke and mortality are also consistent with good outcomes and good case selection,” he added.
Another plus, he noted, is the 17.4% rate of readmission at 30 days, which he called “striking,” since other published reports of younger, less comorbid populations have shown readmission rates as high as 25-30%.
But ultimately, Dr. Feldman said, TAVR is a moving target. “We’re already a year and a half past when these patients received TAVR, so the caveat is that both technique and technology have continued to evolve. It also doesn’t reflect the introduction of a second TAVR device in the US, so it is going to be really interesting to see how this looks in another year.”
Holmes DR Jr, Brennan JM, Rumsfeld JS, et al. Clinical outcomes at 1 year following transcatheter aortic valve replacement. JAMA. 2015;313:1019-1028.
- The study was funded by the ACC Foundation’s National Cardiovascular Data Registry and the STS.
- Dr. Holmes reports no relevant conflicts of interest.
- Dr. Feldman reports receiving consulting fees and grants from Abbott Vascular, Boston Scientific, and Edwards Lifesciences.
- TAVR Improves Health-Related QoL in Majority of Extreme-Risk Patients
- Most Late Cardiac Mortality After TAVR Due to Heart Failure, Sudden Cardiac Death
- Over the Long Haul, TAVR Appears Better Than Surgery for Women