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TVT Registry confirms real-world benefits of TAVR
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WASHINGTON — Nearly all US patients who have undergone transcatheter aortic valve replacement show outcomes with the procedure that are comparable to or better than those reported in clinical trials, according to data from the Transcatheter Valve Therapy Registry presented at American College of Cardiology Scientific Sessions.
“The TVT Registry data can be very successfully linked to CMS Administrative Claims data [97% success rate], which was documented in this study for the first time,” David R. Holmes, MD, study investigator, said at a press conference. “One-year outcome is similar, at least in United States, to those [outcomes] that have been reported in other registries, in terms of the outcomes of PARTNER cohort A and B trials.”
For the study, Holmes, who is Scripps Professor of Medicine at Mayo Clinic, Rochester, Minn., and fellow investigators examined outcomes data for 5,980 patients across 224 sites at 1 year following TAVR (Sapien, Edwards Lifesciences) for native aortic stenosis. All patients were enrolled in the TVT Registry from November 2011 to July 2013, were aged 65 years and older (median, 85 years), and had Medicare insurance.
David R. Holmes
Nearly two-thirds (63.7%) of patients received TAVR via the transfemoral approach.
At the time of the procedure, Holmes and colleagues reported an in-hospital death rate of 5.3% and an in-hospital stroke rate of 1.7%. The rate of any in-hospital valve complication was 2.1% and conversion to open heart surgery was 1.4%.
At 1 year, 26.2% of patients died and 3.6% experienced a stroke, with more than half of patients (55.8%) not requiring rehospitalization.
Demographic characteristics significantly associated with 1-year mortality were age, male gender, severe chronic obstructive pulmonary disease, end-stage renal disease, access site and Society of Thoracic Surgeon predicted risk of mortality score.
“The bottom line for this study is to say that we have identified … factors associated with 1-year mortality and stroke,” said Holmes, a member of the Cardiology Today Editorial Board. “What these associations will be used for is to develop risk-prediction models that physicians and patients can use to try to decide on the optimum strategies for the treatment of aortic stenosis.” – by Brian Ellis
For more information:
Holmes DR. Late-Breaking Clinical Trial V: TCT@ACC-i2. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: Holmes reports no relevant financial disclosures.
Perspective
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Spencer B. King III, MD
The results of the TVT registry look pretty good. It seems like outcomes with TAVR are getting better in general. On the first day of ACC Scientific Sessions, we saw the CoreValve [Medtronic] results that showed for the first time a survival advantage over surgery, followed on the next day by CHOICE, in which the Sapien XT valve looked even better than the CoreValve. Taken together, the results show that outcomes with these transcatheter valves are getting progressively better, which you can expect with a brand-new therapy that is undergoing rapid evolution. My guess is that 5 years from now, we are going to have further evolved valves that are going to be even better.
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