Adverse Events With Perflutren Lipid Microsphere Intravenous Contrast in Subjects With and Without Patent Foramen Ovale Edward A. Gill, MD, Mariko Welch, MD, Thom Schessler, Nayak Polissar, PhD Given the rising prevalence of obesity, there is increasing need for perflutren lipid microsphere intravenous contrast use with echocardiography. It is contraindicated in the suspected or known presence of intracardiac shunt (PFO). Using a large retrospective database, we determined the rate of adverse events among perflutren users, including events in subjects incidentally found to have a PFO. There were two major purposes: 1) Determine the demographics of patients with back pain secondary to perflutren and 2) adverse events when PFO was present Given the rising prevalence of obesity, there is increasing need for perflutren lipid microsphere intravenous contrast use with echocardiography. It is contraindicated in the suspected or known presence of intracardiac shunt (PFO). Using a large retrospective database, we determined the rate of adverse events among perflutren users, including events in subjects incidentally found to have a PFO. There were two major purposes: 1) Determine the demographics of patients with back pain secondary to perflutren and 2) adverse events when PFO was present Introduction All subjects who underwent transthoracic echo (TTE) with the use of perflutren contrast at a tertiary medical center 01/01/ /01/12 were retrospectively assessed. Subjects who experienced adverse events during the 48 hr peri-procedural period were categorized by type of adverse events. All subjects who underwent transthoracic echo (TTE) with the use of perflutren contrast at a tertiary medical center 01/01/ /01/12 were retrospectively assessed. Subjects who experienced adverse events during the 48 hr peri-procedural period were categorized by type of adverse events. All subjects who had undergone a saline contrast study in tandem with perflutren contrast were also evaluated: those subjects who had PFOs diagnosed as result of this index study were compared to those without a PFO. All subjects who had undergone a saline contrast study in tandem with perflutren contrast were also evaluated: those subjects who had PFOs diagnosed as result of this index study were compared to those without a PFO. Conclusions/Discussion Although headache and abnormal taste are said to be the most common side effects of perflutren, we found back pain (43%) to be the most commonAlthough headache and abnormal taste are said to be the most common side effects of perflutren, we found back pain (43%) to be the most common Although our cohort was too small (51) patients to make conclusions about the safety of perflutren in patients found to have a PFO, there were no adverse events in this groupAlthough our cohort was too small (51) patients to make conclusions about the safety of perflutren in patients found to have a PFO, there were no adverse events in this group The incidence of adverse events (0.6%) was too low to make any conclusion about the demographics of the patients with back painThe incidence of adverse events (0.6%) was too low to make any conclusion about the demographics of the patients with back pain Methods Harborview Medical Center, Seattle, WA, USA Adverse Events: Subject Demographics Characteristics of PFO Subjects Pts w/adverse events (n=29) Age (mean ± SD)55.8 ± 12.3 Female sex (%)18 (64.3%) Race/Ethnicity (%) Caucasian17 (59%) Black8 (28) Hispanic3 (10%) Native American1 (3%) Asian0 (0.0%) Echocardiography Transthoracic Echo11 (39.3%) Stress Echo17 (60.7%) History of chronic back pain (%)5 (17.3%) History of CAD (%)13 (46.4%) History of stroke (%)3 (10.3%) History of renal disease (%)4 (14.3%) Body Mass Index (mean ± SD)36 ± 8.7 Charlson Comorbidity Index (mean ± SD)6.2 ± 3.2 Pts w/ PFO (n = 51)Pts w/o PFO (n = 107) Age (mean ± SD)59.6 ± ± 12.5 Female sex (%)16 (31.4%) 35 (32.7%) Race/Ethnicity (%) Caucasian20 (39.2%)49 (45.8%) Black16 (31.4%)35 (32.7%) Hispanic3 (5.9%)4 (3.7%) Native American2 (3.9%)1 (0.9%) Asian10 (19.6%)18 (16.8%) Echocardiography Transthoracic Echo31 (60.8%)58 (54.2%) Stress Echo20 (39.2%)49 (45.8%) History of chronic back pain (%)5 (9.8%)20 (18.7%) History of CAD (%)22 (43.1%)44 (41.1%) History of stroke (%)19 (37.3%)52 (48.6%) History of renal disease (%)12 (23.5%)16 (15.0%) Body Mass Index (mean ± SD)31.0 ± ± 8.1 Charlson Comorbidity Index (mean ± SD)7.0 ± ± 3.7 Results Adverse events were reported in 29 patients of the 4,722 total receiving perflutren. None of these individuals underwent a saline contrast study to determine if PFO was present.Adverse events were reported in 29 patients of the 4,722 total receiving perflutren. None of these individuals underwent a saline contrast study to determine if PFO was present. Back pain was the most frequently reported adverse event (43%). No CVAs or MIs were reported in the entire cohort. Back pain was the most frequently reported adverse event (43%). No CVAs or MIs were reported in the entire cohort. 51 patients were identified that had received perflutren and later were found to have a PFO. None had any adverse events within 48 hours of the initial TTE. 51 patients were identified that had received perflutren and later were found to have a PFO. None had any adverse events within 48 hours of the initial TTE.