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Long-Term Outcomes Encouraging for High-Risk Patients Undergoing TAVR
Moat NE. J Am Coll Cardiol. 2011;58:2130-2138.
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Survival for high-risk patients with severe aortic stenosis after transcatheter aortic valve replacement appears promising, despite a large number of patients who died at 1 year, according to results of the UK TAVI Registry.
In the study, investigators examined characteristics of a “real-world population” treated with TAVR, including 870 patients from 25 centers between January 2007 and December 2009, and evaluated mid- to long-term survival.
Survival for the first month after implantation was 92.9%, with higher rates reported in the non-transfemoral implant group vs. those who received transfemoral TAVR (P=.03). The mortality rate dropped to 78.6% at 1 year and 73.7% at 2 years, with no differences reported at 1 year for patients given either the Sapien valve (Edwards Lifesciences) or the CoreValve (Medtronic). However, at both 1 and 2 years, there was a significant difference in mortality favoring the transfemoral TAVR group when compared with the non-transfemoral group.
Independent predictors of survival in a multivariate model included left ventricular ejection fraction less than 30%, moderate/severe aortic regurgitation and chronic obstructive pulmonary disease.
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The registries are important research tools for understanding the impact of therapeutic interventions in the ‘real world.’ Their value depends on their methodology, quality of data and completeness. The all-inclusive UK TAVI registry gets high marks in this regard, although there was no systematic audit of the data or core lab. The site reported that procedural and in-hospital data were complete in more than 96% of patients and mortality tracking was successful 100% of the time. The results indicate, similar to other studies, that TAVR can be performed safely in very severe AS patients with acceptable 30-day mortality risk, although important challenges remain, such as stroke, vascular complications, aortic regurgitation and need for pacemaker. The outcome is not as good in the non-femoral approach patients, which may in part be due to patient characteristics. Overall, there does not seem to be any difference in outcomes between the two different types of valves except the higher pacemaker rate in the self-expanding CoreValve. This study is important because it reports from all patients that underwent TAVR in a country. Also, it is the first large study reporting outcome beyond 1 year.
– E. Murat Tuzcu, MD
Cardiology Today
Intervention Editorial Board member
Disclosure: Dr. Tuzcu
reports no relevant financial disclosures.