Key result
TAVR in high-risk patients yields ~5% in-hospital mortality in real-world registry data.
Why the study?
TAVR complication rates and perioperative outcomes in a large real-world cohort were not fully characterized.
Observational (n=15,964)
Yes
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The GARY registry has disclosed good outcomes after TAVR and a survival of ∼60% of TAVR patients who experienced severe vital complication. In addition, severe complications have steadily decreased over time.”
In a large prospective national registry, TAVR in high-risk patients demonstrated good perioperative outcomes with an in-hospital mortality of 5.2% and an overall severe vital complication rate of 5.0%.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. OBJECTIVES: TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). METHODS: From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. RESULTS: Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. CONCLUSIONS: The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients.
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Walther et al. (2015) conducted an observational in Severe aortic stenosis requiring transcatheter aortic valve replacement (n=15,964). Transcatheter aortic valve replacement (TAVR) was evaluated on Overall in-hospital mortality. In a national registry of 15,964 high-risk patients undergoing transcatheter aortic valve replacement, overall in-hospital mortality was 5.2% and severe vital complications occurred in 5.0%.
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