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Purpose: Angiographic equipment is a key component of healthcare infrastructure, used for endovascular procedures throughout the body. The literature on adverse events related to this technology is limited. The purpose of this study was to analyze adverse events related to angiographic devices from the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Methods: MAUDE data on angiographic imaging equipment from July 2011 to July 2021 were extracted. Qualitative content analysis was performed, a typology of adverse events was derived, and this was used to classify the data. Outcomes were assessed using the Healthcare Performance Improvement (HPI) and Society of Interventional Radiology (SIR) adverse event classifications. Results: There were 651 adverse events reported. Most were near misses (67%), followed by precursor safety events (20.5%), serious safety events (11.2%), and unclassifiable (1.2%). Events impacted patients (42.1%), staff (3.2%), both (1.2%), or neither (53.5%). The most common events associated with patient harm were intra-procedure system shut down, foot pedal malfunction, table movement malfunction, image quality deterioration, patient falls, and fluid damage to system. Overall, 34 (5.2%) events were associated with patient death; 18 during the procedure and 5 during patient transport to another angiographic suite/hospital due to critical failure of equipment. Conclusion: Adverse events related to angiographic equipment are rare; however, serious adverse events and deaths have been reported. This study has defined a typology of the most common adverse events associated with patient and staff harm. Increased understanding of these failures may lead to improved product design, user training, and departmental contingency planning., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Since the first peripheral endovascular intervention (PVI) in 1964, the procedure's technical aspects and indications have advanced significantly. Today, endovascular procedures span the spectrum of presentations from acute limb ischemia to critical limb ischemia and symptomatic limiting claudication. Goals of PVI remain restoring limb perfusion, minimizing rates of amputation and mortality, and sparing the need for the high-risk bypass surgery. Unfortunately, there are no large randomized controlled trials that address the optimal approach to peripheral arterial disease revascularization in chronic kidney disease (CKD) patients., Competing Interests: Disclosure The authors have nothing to disclose., (Published by Elsevier Inc.)

The most common risk associated with angiography contrast injectors is air embolism. Injector manufacturers have attempted to address this concern by adding air detection systems and other safety features. Find out which injectors do the best job of protecting patients.

Computed tomographic angiography (CTA), magnetic resonance angiography (MRA), and diagnostic arteriography are all vascular diagnostic tools that may be included in modern vascular diagnostic laboratories. Before undertaking the establishment of such an all-purpose diagnostic, and possibly interventional, facility the vascular specialist or group needs to ensure safe patient care and the ability to provide these diagnostic tests and procedures without incurring a financial loss. This article will detail one method of setting up such a facility and suggest some other approaches. It will also introduce some of the issues that may change the legislative landscape in the Unites States of America (USA) and may make these arrangements more complex in that country.

Purpose: To determine prospectively the incidence of adverse events in angiography related to contrast agents, and the relative incidence of events with use of high-osmolality contrast agents (HOCAs) and low-osmolality contrast agents (LOCAs) and to ascertain if risk factors can help identify increased risk of an adverse event and patients likely to benefit from use of LOCAs., Materials and Methods: From 26 high-volume institutions, data were collected on every patient who underwent angiography from July 1, 1990, to June 30, 1992. Information included demographic and risk factors, general medical status, previous administration of contrast media, procedural information, occurrence and characteristics of all adverse events up to 12 hours after procedures, and relation to contrast agents, treatment, and outcome., Results: In 60,891 patients, there were 75,616 studies, 56% with nonionic LOCAs, 8% with the ionic LOCA, and 36% with HOCAs. Most major risk factors correlated with an increased incidence of adverse events related to contrast media. Incidence of these adverse events varied with type of procedure, with a higher incidence associated with cardiac and interventional procedures. Overall adverse events related to contrast media and those for which treatment was necessary were significantly increased (P < .001) with use of HOCAs for all but arterial interventional procedures. Serious adverse events were not different between the two classes of agents except for cardiac procedures. Previous reaction to contrast medium was the most important risk factor in prediction of an adverse event., Conclusion: The safety benefit of use of LOCAs is limited. Patients most likely to benefit are those with a previous reaction or more than one other major risk factor. Selective use of LOCAs is an appropriate strategy.

A national survey on informed-consent lawsuits that resulted from studies using contrast material revealed that 123 (8%) of 1,513 radiologists surveyed or others in their groups had been involved in informed-consent lawsuits. In response to a detailed follow-up questionnaire, 67 radiologists anonymously provided additional information regarding their lawsuits, which most often involved excretory urography (37%) or angiography (38%), with death or neurologic impairment the most common patient injuries. As a result of these lawsuits, many radiologists provide more detailed information to patients. In the United States, the total number of informed-consent lawsuits, however, was small in relation to the total number of studies done using contrast material.

A nationwide survey of complications due to coronary arteriography during 1973--74 yielded responses from 176 hospitals (89,079 coronary arteriograms). The overall mortality rate was 0.14% (brachial, 0.12%; femoral, 0.16%). In the brachial group, the mortality rate was three times as high for non-heparinized as for heparinized patients. In institutions performing fewer than 100 examinations per year, the combined incidence of death, myocardial infarction, and cerebral embolism was five times higher than in institutions performing more than 400 examinations per year. Left main coronary artery or three-vessel disease was present in most patients who died of the procedure. Compared to a previous survey of 1970--71, there was a profound decrease in significant complications (including death, myocardial infarction, and cerebral embolism) and entry site complications such as thrombosis. A reduction in mortality with the femoral technique since 1971 was not accounted for by heparinization and may reflect increasing experience with the method and shorter angiographic times.

Case reports on 112,003 patients obtained through a prospective survey have been studied and submitted to computer processing. The significant findings have been reviewed and their importance discussedmthe following points are noteworthy: the value of pretesting is doubtful; and routine pretesting is not a recommended procedure. The constant readiness of a fully equipped emergency tray offers far greater security and assurance of patient safety than the unpredictable and unreliable results of pretesting. The over-all incidence of nonfatal reactions is lower than has been prviously indicated: 5.65 per cent for intravenous urography; and 2.33 per cent for intravascular studies. The incidence of fatal reaction (1 in 10,000) is higher than that reported on the basis of retrospective studies. This figure may or may not be duplicated in the next 100,000 examinations. The cause of death in some patients may be related to a combination of factors-primary disease, diagnostic procedure, and contrast medium. The over-all incidence of adverse reactions in patients with allergy is about twice that in the general population. The incidence of adverse reactions is highest in the third and fourth decades, and lowest at either end of the age spectrum. Incidence of reactions is equal in both sexes. History of reaction to previous examinations is not a contraindication to re-examination. The incidence is approximately 3 times that of the general population. Rapid injection rate, in intravenous urography, is accompanied by fewer reactions than a slow injection rate. A slow injection rate in intravenous cholangiography is accompanied by fewer ractions than a rapid injection rate. It is anticipated that this program will continue, so that additional meaningful data and significant information will be accumulated. The members of our Committee are of the firm belief that this program will become the foundation of a permanent national and international adverse reaction reporting system, thus meeting a great need. We invite the collaboration and support of all those interested and involved in the many phases of contrast medium work.

The risk of coronary angiography has been decreasing since development of the procedure 19 years ago. Deaths resulting from angiography now occur only in high-risk clinical circumstances. Whether a certain case load per angiographer or laboratory is necessary for adequate safety is still a question. Even though little available data exist on the relationship of case loads to risk, the National Guidelines for Health Planning now require 300 cardiac catheterizations per laboratory per year and forbid development of new laboratories in hospitals without heart surgery programs. Data collected from all 16 laboratories in Washington showed 26 deaths (0.19%) during 14,050 coronary angiograms. Eighteen of those who died had a severe left main coronary obstruction, and three had severe triple-vessel disease. There were 18 myocardial infarctions (0.13%) and nine strokes (0.06%). The risks in hospitals without cardiac surgery programs and in hospitals performing fewer than 200 cases per year were no higher than in the other hospitals studied. The National Guidelines should be reevaluated before they are used to change the existing pattern of health care.