Studies have shown that permanent pacemaker implantation is among the most common complications for patients undergoing transcatheter aortic valve replacement (TAVR). Still, the risk may be underestimated, according to a recent analysis.
The reason for the potential discrepancy? Most studies that have reported permanent pacemaker rates following TAVR have included patients who already had a pacemaker before TAVR.
For instance, the researchers mentioned that prior reports noted that approximately 6 percent of patients receiving the Sapien and/or Sapien XT valve (Edwards Lifesciences) and 28 percent of patients receiving the Corevalve (Medtronic) had permanent pacemakers.
This analysis, which was published online Nov. 21 in the Journal of the American College of Cardiology, evaluated 28 multicenter registries and six randomized trials that enrolled patients with severe aortic stenosis who underwent TAVR.
The researchers calculated the estimated real incidence of permanent pacemaker implantations by excluding patients who died within 30 days of undergoing TAVR and those who had a pacemaker before the procedure. They also calculated an estimated minimal incidence of permanent pacemaker implantations by assuming all patients who died had pacemakers. In addition, they calculated an estimated maximal incidence by assuming one of the patients who died had pacemakers.
“The chief finding of this analysis is that TAVR studies tend to systematically underestimate the real incidence of new [permanent pacemaker] rates by failing to consider patients with prior [permanent pacemakers],” the researchers wrote. “Controversy still exists regarding the long-term impact of new [permanent pacemakers] post-TAVR, but the short- and long-term risks and morbidity associated with PPM are well known. Therefore, it would be important to consider these results in future TAVR studies especially with the shift towards implanting newer generation devices within lower-risk patients. Also, these results should be taken into account when advising TAVR candidates without prior [permanent pacemakers] about the risks of the procedure.”
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.