&C POSITION STATEMENT Use of ~onionic or Cardiovascular ~~~~ed~res AMERICAN COLLEGE OF CARDIOLOGY CARDIOVASCULAR IMAGlNG COMMITTEE”

lodinated radiopaque contrast agents are utilized in many of the approximately I million or more cardiac carherenzalions performed each year in the United States. Until recently. the primary agents employed for cardiovascular imaging consisted of diatrizoate sodium or a combination of diatrizoate sodium and various m&urdne salts. These agents are referred to as “ionic” or “idgh osmolar” agent> and have osnwlalifies exceeding 1.X0 mOsm!kg. The cardiovascular effects of the conventional high osmolar iodinated contrast agents are well investigated (1-6). In recent years (1986 to the present). several “nonionic” or “low osmolar” agents have been introduced and wdely marketed m the U.S. These include iohexol (Omnipeqx. Winthrop). iopamidol (lsovue. Squibb) and ioversol (Optiray, Mallinckmdtf. An additional agent. ioxaglate (Hexabrix. Mallinckrodt) is best described as an ionic. but low osmoiar contrast agent. We will subsequently refer to this group of agents interchangeably as either nonionic or low osmolar. unless specified otherwise. This policy statement does not apply to-other classzs of contrast-agents that may become available in the future. All four of these newer agents have osmolalities in the range of apprJximarely 6W to 763 m0smlkg. The cardiovascular e5ects of the newer low osmolar agents have been thoroughly investigated during premarkeiing surveillance and subsequent clinical use (714). These data suggest that the low osmolar agents are better tolerated than the high osmolar agents and are possibly safer in hemodynamically compromised patients. hut that the low osmolar agents are much more expensive. The low osmolar ag&ts cost hospital Qharm&ies approximately $ltM/lMl ml. This represents approximately IO times the cost of conventional ionic agents. Despite the high cost. use of these agents is increasing and is now estimated to represent approximately 60% to 707~ of currem practice in cardiac catheterization. The conversion to the ower low osmolar agents for cardiac catheterization represents a subsrantial cost to hospitals. insurers and patients. Total replacement of ionic contrast usage by nonionic agents for cardiovascular procedures will add approximately $100 to T2W million to the annual U.S. health care budget. Replacement of ionic agents by nonionic or low osmolar contrast media for all radiographic procedures is estimated to add $1.1 to I.5 billion to health care costs. Cootroveny exists over whether the possible safety benefits of low osmolar agents outweigh their substantial increase in costs.