German Registry Documents the Increased Use and Improved Outcomes for TAVR

September 20, 2015—Patrick Serruys, MD, Editor-in-Chief of EuroIntervention, and Darren Mylotte, MD, Associate Editor of EuroIntervention, announced the expedited editorial publication of a study by Holger Eggebrecht MD, and Rajender Mehta, MD, which analyzed the use of transcatheter aortic valve replacement (TAVR) in Germany from 2008 to 2014. The study is available online ahead of print in EuroIntervention.

According to Drs. Serruys and Mylotte, the study “…details the astonishing growth of TAVR in Germany. In 2013, the number of TAVR first surpassed isolated surgical aortic valve replacement (SAVR), and TAVR now exceeds isolated SAVR by a factor of 1.3. TAVR growth continues unabated, with continued growth in implant rates of 15–20% per annum, and without evidence of the 'implant plateau' observed in most European nations.”

They added, “Surprisingly, the rates of SAVR are unaffected by the rise of TAVR. These data imply that TAVR must be treating the 30–50% of patients with severe aortic stenosis that were historically denied SAVR. [The investigators] also document the application of this technology to lower-risk patient groups, as well as impressive reduction in in-hospital mortality among TAVR recipients. Improved patient selection and screening, operator experience, and device iteration probably account for these results. It is also important to note that surgical outcomes have improved since the widespread adoption of TAVR.” 

Drs. Serruys and Mylotte concluded, “The overall implication from this paper is that for the first time, national data from the largest country in Europe report an immense increase in TAVR procedures over time with a secondary trend toward choosing lower-/intermediate risk patients. The question now is: will we see, in the near future, a similar rise across Europe?”

In EuroIntervention, the investigators noted that all TAVR and SAVR procedures in Germany are registered within an obligatory quality assurance program led by the independent AQUA Institute. In order to provide a comprehensive overview of developments between 2008 and 2014, the investigators summarized patient and procedural characteristics, complication and mortality rates as reported in the annual, German-language AQUA quality reports, which are freely accessible online.

The investigators found that a total of 71,927 isolated SAVR and 48,353 TAVR procedures have been performed in Germany since 2008. The number of SAVR procedures has declined steadily from 11,205 in 2008 to 9,953 in 2014.

During the same time, there has been a 20-fold increase in TAVR procedures, from 637 procedures in 2008 to 13,264 procedures in 2014, surpassing the annual numbers of isolated SAVR since 2013. 

The age profile of TAVR patients has remained unchanged over time (mean age, 80.9 years), with a recent trend toward lower-risk/intermediate-risk patients. TAVR complications are rapidly decreasing (2012, 9.4%; 2014, 3.9%); annular rupture, aortic dissection, and coronary occlusions are rare (< 0.3%), with fewer patients requiring surgical conversion to sternotomy (2012, 1.2%; 2014, 0.6%). The investigators reported that in-hospital mortality after TAVR has halved in 2014 (4.2%) compared with 2008 (10.4%).

From these findings, the investigators concluded that the data document the rapid adoption of TAVR in Germany, shifting treatment of aortic valve stenosis in the elderly from surgery to a catheter-based approach. 

Similar to what happened with percutaneous coronary interventions, the complications of TAVR have declined considerably along with the need for emergency cardiac surgery, and most importantly, in-hospital mortality has halved from 2008 to 2014, while mortality for SAVR has remained unchanged.