Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry.

In this manuscript the authors report on data from the German Aortic Valve Registry (GARY) comprising 15964 transcatheter aortic valve replacement (TAVR) procedures performed from 2011 to 2013 evaluating severe vital complications (SVCs), technical complications of the procedures (TCOs), other complications, conversion to sternotomy and in-hospital death. Patients’ mean age was 80.9 years. A balloon expandable prosthesis was used in 52.6% of the cases. An average 5% of the patients experienced SVCs, with a significant decrease in SVCs from 6.8% (in 2011) to 4.9% (in 2012) and 3.9% (in 2013). Residual aortic regurgitation was detected in 5.8% of patients. Need for pacemaker implantation occurred in 17.5% of patients. Stroke was diagnosed in 1.5%. Technical complications occurred in 748 patients (4.7%). Conversion to sternotomy was required in 201 patients (1.3%). Major vascular complications occurred in 4.1%. All these complications showed a significant decline in prevalence during the study period.
Logistic Euroscore and STS score were 18.3 and 5.0 respectively. A total of 828 patients (5.2%) died during the procedures or during the hospital stay. Interestingly, multivariate analysis showed that the transapical approach was not an independent predictor of death. The authors conclude that TAVR therapy is safe with acceptable complication rates (decreasing over time) in an all-comers and high-risk patient population.