Background: Physicians have a legal and ethical responsibility to provide adequate information to patients so appropriate, informed decisions can be made. Although clinical trial data suggest that the incidence of complications associated with invasive coronary procedures is relatively low, contemporary data from real world, non-trial related populations are lacking, and this has implications for the informed consent process. This study revises the consent form for coronary angiography procedures using clinical registry data.
Methods: A statewide patient risk information sheet and procedure consent form was developed for patients undergoing coronary angiography and/or percutaneous coronary intervention (PCI) in South Australian (SA) public hospitals (population 1.6 million). The risk information was generated from data obtained via the Coronary Angiogram Database of South Australia (CADOSA), a comprehensive registry of all public angiograms and PCIs performed in SA, compatible with the NCDR® CathPCI® Registry. All consecutive patients undergoing procedures in 2012-2014 were included.
Results: From 15,121 angiographic procedures performed, 28% were elective (4,234 of 15,121) and 4,617 were PCI (30%). Patients had a mean age of 65±13 years, 34% (5,096 of 15,121) were female and radial access was frequent at 60% (9,032 of 15,121). Procedural complications for angiography (n=10,504) and PCI (n=4,617), respectively were: mortality within 24 hours: 0.06%, 0.45%; stroke within 24 hours: 0.13%, 0.19%; haemorrhagic stroke: 0.03%, 0.04%; emergency CABG: 0.02%; 0.13%; major bleeding: 0.48%, 1.58%; access site bleed: 0.26%, 0.56%; other vascular complications at access site: 0.07%, 0.09%; new onset/worsening heart failure: 0.45%, 0.95%; requirement for dialysis: 0.11%, 0.17%, tamponade: 0.03%, 0.15%; significant dissection during PCI 1.13% and perforation during PCI: 0.19%. The rates of complications were listed in the patient risk information sheet in the form of ‘per number of procedures’ with 1,000 as the denominator for most events.
Conclusion: In a representative assessment of coronary angiography and PCI outcomes, some major complications are higher that those reported in international literature. Significant access site bleeding was low, likely explained by the high prevalence of radial procedures. Future iterations of the patient information sheet and consent form may be improved by providing personalized risks.