Safety profile of ultrasound enhancing agents in echocardiography

Suwen Kumar, Chris Purtell, April Peterson, Paul Gibbons, Abigail Khan, Stephen Heitner

Research output: Contribution to journalArticle

Abstract

Introduction: Ultrasound enhancing agents (UEAs) are often utilized to enhance ultrasound image quality; however, concerns about adverse reactions have limited their use. Moreover, these agents had been either contraindicated or are labeled with a warning in patients with intra-cardiac shunts because of a theoretic risk of systemic microvascular obstruction. This labeling was recently removed in the United States, but data in these patients are lacking. Methods: Over a 15-month period, patients receiving three different FDA-approved UEAs at our center were prospectively evaluated for clinically significant adverse events (AEs). Results: A total of 5521 UEA administrations were performed (Definity ® : 3306, Lumason ® : 2137, Optison ® : 78). There were 14 AEs (0.25%) reported (Lumason ® : 0.05% [n = 1] vs Definity ® : 0.39% [n = 13], P = 0.02). Back pain was the most common complaint (n = 9), followed by headache (n = 2), rash (n = 2), dyspnea (n = 2), and palpitations (n = 1). Among the 33 patients known to have intra-cardiac shunts, there were no AEs. Known right-to-left shunts with positive saline bubble study were present in 20 patients (Lumason ® : n = 9, Definity ® : n = 11). Left-to-right atrial shunts based on color Doppler were present in 10 patients (Lumason ® : n = 5, Definity ® n = 5). Three patients were known to have ventricular septal defect with left-to-right flow (Definity ® : n = 2, Optison ® : n = 1). Conclusion: Adverse events were significantly higher with Definity ® ; however, overall incidences were low, and AEs were minor. Furthermore, no AEs were reported in patients with known intra-cardiac shunts. UEAs showed a good safety profile in our study and should be afforded to all appropriate patients, including those with known intra-cardiac shunts.

Original languageEnglish (US)
JournalEchocardiography
DOIs
StatePublished - Jan 1 2019

Fingerprint

Echocardiography
Safety
Ventricular Heart Septal Defects
Back Pain
Exanthema
Dyspnea
Headache
Definity
Color
Incidence

Keywords

  • contrast agents
  • Definity
  • echocardiography
  • Lumason
  • Optison
  • ultrasound enhancing

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Safety profile of ultrasound enhancing agents in echocardiography. / Kumar, Suwen; Purtell, Chris; Peterson, April; Gibbons, Paul; Khan, Abigail; Heitner, Stephen.

In: Echocardiography, 01.01.2019.

Research output: Contribution to journalArticle

Kumar, Suwen ; Purtell, Chris ; Peterson, April ; Gibbons, Paul ; Khan, Abigail ; Heitner, Stephen. / Safety profile of ultrasound enhancing agents in echocardiography. In: Echocardiography. 2019.
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N2 - Introduction: Ultrasound enhancing agents (UEAs) are often utilized to enhance ultrasound image quality; however, concerns about adverse reactions have limited their use. Moreover, these agents had been either contraindicated or are labeled with a warning in patients with intra-cardiac shunts because of a theoretic risk of systemic microvascular obstruction. This labeling was recently removed in the United States, but data in these patients are lacking. Methods: Over a 15-month period, patients receiving three different FDA-approved UEAs at our center were prospectively evaluated for clinically significant adverse events (AEs). Results: A total of 5521 UEA administrations were performed (Definity ® : 3306, Lumason ® : 2137, Optison ® : 78). There were 14 AEs (0.25%) reported (Lumason ® : 0.05% [n = 1] vs Definity ® : 0.39% [n = 13], P = 0.02). Back pain was the most common complaint (n = 9), followed by headache (n = 2), rash (n = 2), dyspnea (n = 2), and palpitations (n = 1). Among the 33 patients known to have intra-cardiac shunts, there were no AEs. Known right-to-left shunts with positive saline bubble study were present in 20 patients (Lumason ® : n = 9, Definity ® : n = 11). Left-to-right atrial shunts based on color Doppler were present in 10 patients (Lumason ® : n = 5, Definity ® n = 5). Three patients were known to have ventricular septal defect with left-to-right flow (Definity ® : n = 2, Optison ® : n = 1). Conclusion: Adverse events were significantly higher with Definity ® ; however, overall incidences were low, and AEs were minor. Furthermore, no AEs were reported in patients with known intra-cardiac shunts. UEAs showed a good safety profile in our study and should be afforded to all appropriate patients, including those with known intra-cardiac shunts.

AB - Introduction: Ultrasound enhancing agents (UEAs) are often utilized to enhance ultrasound image quality; however, concerns about adverse reactions have limited their use. Moreover, these agents had been either contraindicated or are labeled with a warning in patients with intra-cardiac shunts because of a theoretic risk of systemic microvascular obstruction. This labeling was recently removed in the United States, but data in these patients are lacking. Methods: Over a 15-month period, patients receiving three different FDA-approved UEAs at our center were prospectively evaluated for clinically significant adverse events (AEs). Results: A total of 5521 UEA administrations were performed (Definity ® : 3306, Lumason ® : 2137, Optison ® : 78). There were 14 AEs (0.25%) reported (Lumason ® : 0.05% [n = 1] vs Definity ® : 0.39% [n = 13], P = 0.02). Back pain was the most common complaint (n = 9), followed by headache (n = 2), rash (n = 2), dyspnea (n = 2), and palpitations (n = 1). Among the 33 patients known to have intra-cardiac shunts, there were no AEs. Known right-to-left shunts with positive saline bubble study were present in 20 patients (Lumason ® : n = 9, Definity ® : n = 11). Left-to-right atrial shunts based on color Doppler were present in 10 patients (Lumason ® : n = 5, Definity ® n = 5). Three patients were known to have ventricular septal defect with left-to-right flow (Definity ® : n = 2, Optison ® : n = 1). Conclusion: Adverse events were significantly higher with Definity ® ; however, overall incidences were low, and AEs were minor. Furthermore, no AEs were reported in patients with known intra-cardiac shunts. UEAs showed a good safety profile in our study and should be afforded to all appropriate patients, including those with known intra-cardiac shunts.

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