Continuous interval monitoring was performed during each study until valve deployment. A temporary pacemaker was used in cases of heart block, “per standard practice.”
Overall, this practice was found to be both safe and feasible. All EP studies were successful.
“Only one case required a temporary pacemaker for rapid pacing because of an inadequate threshold in a hemodynamically unstable patient,” the authors wrote. “Complications were rare: two patients developed new atrial fibrillation attributed to asynchronous pacing. No perforation, pericardial effusion or loss of capture during valve deployment was seen.”
The researchers added that routine EP studies did not make TAVR procedures significantly longer. In addition, TAVR operators quickly caught on to what was needed despite beginning the pilot study with no prior EP study experience.
One key limitation of this study was its small sample size. The authors acknowledged this in their analysis, writing that a larger clinical trial of 400 patients is already underway.
“Incorporating the study in a stepwise approach minimally affects TAVR cases and aids in patient management,” the group concluded. “The information obtained from direct assessment of the conduction system during TAVR will be studied in a large clinical trial.”
Read the full study here.