Advanced heart block and unresponsiveness after regadenoson administration during myocardial SPECT study

Safety and tolerability of regadenoson for myocardial perfusion imaging – first Danish experience

“…Since the approval by the Food and Drug Administration in 2008, multiple prospective US studies have reported safety data (7)(8)(9)(10). However, in clinical practice, outside of controlled clinical trials, a number of case reports have documented severe adverse events (AEs) with regadenoson for MPI stress testing, e.g., advanced heart block, asystole, and acute myocardial infarction (MI) (11)(12)(13)(14). These safety issues have led to some concerns in the medical community (15).…”

Adverse effects associated with regadenoson myocardial perfusion imaging

“…4 Despite this initial observation, there have since been isolated case reports and small case series describing the occurrence of de novo advanced heart block and asystole following regadenoson and requiring immediate management and stabilization. [29][30][31][32][33][34][35] As of June 2017, a total of 56 cases of third-degree heart block and 26 cases of sinus arrest associated with regadenoson stress testing were reported via FAERS. 15 In a recent meta-analysis, the incidence of overall and high-grade AV block-defined as secondand third-degree AV block-related to the administration of regadenoson at the dose given during MPI was low (less than 0.5%) and observed much less frequently with regadenoson compared to adenosine (incidence of de novo overall AV block with adenosine was 8.58%; 95% CI 5.55% to 12.21% vs. regadenoson which was 0.30%; 95% CI 0.04% to 0.82%, P \ 0.001, OR 30.6; 95% CI 11.0 to 85.3; incidence of high-grade AV block for adenosine was 5.21%; 95% CI 2.81%-8.30% vs regadenoson which was 0.05%; 95% CI \ 0.001%-0.19%, P \ 0.001, OR 77.2; 95% CI 20.3 to 293.0) (Figure 1).…”

Regadenoson and seizures: A real clinical concern

“…1 While the episode of advanced heart block completely resolved after the administration of intravenous aminophylline, her altered mental status required critical care level of monitoring and serial CT scans to rule out organic pathology as the underlying etiology of the episode of unresponsiveness.…”