In Germany, almost all of the marked increase in the use of transcatheter aortic valve replacement (TAVR) since the procedure’s introduction in 2007 occurred in patients unsuited to a surgical approach because of their advanced age or elevated risk, according to an analysis published online Dec. 17 in the New England Journal of Medicine.
The surgical aortic valve replacement (SAVR) is still the standard of care, but many have questioned how the relatively new transcatheter approach has affected clinical practice overall, said Dr. Jochen Reinöhl of the Heart Center, University of Freiburg (Germany) and his associates.
To assess the evolution of treatment since TAVR was introduced, the investigators analyzed data from the Institute for the Hospital Remuneration System, which tracks all patient data regarding diagnoses, comorbidities, and procedures throughout the country. They focused on all 88,573 admissions for isolated surgical aortic valve replacements (55,992 procedures) and for isolated TAVR (32,581 procedures) performed in Germany during 2007-2013.
The number of TAVR procedures increased markedly over time, from 144 to 9,147 per year, while the number of SAVRs declined only slightly, from 8,622 to 7,048 per year. Patients aged 80 years and older accounted for almost all of the dramatic increase in transcatheter procedures, the investigators said (N Engl J Med. 2015 Dec 17;373:2438-47 [doi:10.1056/NEJMoa1500893]).
Overall in-hospital mortality was significantly higher with TAVR (6.5%) than with SAVR (2.8%), for an odds ratio of 2.41. This likely reflects the significantly greater risk of patients selected for TAVR, compared with those undergoing surgery, they said.
Mortality decreased over time in both patient groups, from 3.8% to 2.2% with surgery and from 13.2% to 5.4% with TAVR. In the case of TAVR, this decline is likely from a “learning curve” effect among clinicians, improvements in patient care, and advances in treatment devices. In the case of surgery, the mortality decline is probably due in part to the shift of high-risk patients from SAVR to the transcatheter approach, Dr. Reinöhl and his associates said.
Similarly, complications were significantly more common with TAVR. The need for permanent pacemaker implantation was the most frequently reported complication of TAVR, occurring in 17.7% of the transcatheter group but only 4.0% of the surgical group. Stroke rates (2.5% vs. 1.8%) and rates of acute kidney injury (5.5% vs. 3.0%) followed a similar pattern. In contrast, bleeding complications were more frequent with surgery (14.0% vs. 8.2%).