ABC | Volume 114, Nº1, January 2019

Statement Position Statement of the Brazilian Cardiology Society and the Brazilian Society of Hemodynamics and Interventional Cardiology on Training Centers and Professional Certification in Hemodynamics and Interventional Cardiology – 2020 Arq Bras Cardiol. 2020; 114(1):137-193 Annex 3 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE PROCEDURE OF CORONARY ANGIOPLASTY WITH OR WITHOUT STENT IMPLANTATIONS By the present Consent and Authorization Form, I, ........................................................................................................, nationality ................................................, a legal adult and able, marital status .........................................................., profession ....................................................., identity document ......................................................., issued by ......................................., CPF ...................................................., resident of ............................................................................................................ ..............................., city .............................................................., state ....................., date of birth ........../........../.........., parents’ names ........................................................................................................................................., hereby declare that I have received from the Hemodynamics Service, here represented by the physician fully identified below, explanations and warnings concerning the procedure solicited by my clinical physician and that the discussion regarding the nature and extent of the actions necessary for its execution is registered below. I further declare that it has been explained to me that the procedure of coronary angioplasty with or without stent implantations will be performed in the hemodynamics laboratory of this hospital institution (corporate name ................................................. ............................................., CNPJ/MF no. ...................................headquarters....................................................................) and that it consists of punctures in the patient’s skin in order to introduce special catheters, using iodized contrast, with the administration of local anesthesia, sedation, or general anesthesia, at the attending physician’s discretion. The following text has been read and explained to me in more accessible language by the signing physician: the objective of this procedure is to treat obstructions or blocks in the arteries that irrigate or supply the heart, known as coronary arteries. The procedure consists of the insertion of a fine catheter through a puncture in the radial artery or the inguinal region, at the physician’s discretion. By means of this fine catheter, iodized contrast, and X-rays, the obstructed or blocked coronary artery(ies) will be approached with one or more very fine guidewires, and a balloon catheter and a very small metallic mesh called a “stent” may be utilized to unblock the artery. Depending on the type of block, other devices may be used to treat the coronary artery(ies), such as the Rotablator, which consists of a very small burr used to unblock extremely calcified (hard) arteries, and a balloon catheter that cuts the plaque or the coronary artery block may also be used. In addition to treatment with the diverse materials mentioned, medications that help decrease the occurrence of clots, such as glycoprotein IIb/IIIa antagonists or other antiplatelet agents, may be used. Moderate or angiographically indeterminate coronary artery blocks may be assessed by means of a very fine guidewire dedicated to assessing these types of blocks. To facilitate the success of this treatment, intravascular ultrasound study, by means of a microcatheter dedicated to this purpose, may be introduced into the coronary artery to guide stent placement. In the event of a medical emergency, a balloon catheter with a diameter similar to that of the aorta may be used and positioned in the descending thoracic portion to facilitate the filling of coronary arteries. I declare that, in the manner explained to me by the physician, I am perfectly able to understand what the procedure which I am to undergo will comprise. I declare that I am aware that the intended purpose of performing the forenamed procedure may not be achieved, even though the physician and his/her team adopt the best techniques and employ all of the scientific means and resources available. I am also aware that the procedure involves risks, and I have received all the pertinent information regarding possible complications due to known and unknown causes, including death, stroke, myocardial infarction, cardiac arrhythmia, acute pulmonary edema, anaphylactic shock, varying types and degrees of infection, allergies and/or reactions to contrast, bleedings, hematomas, renal insufficiency, vascular and hemodynamic complications, perforation of cardiac chambers or vessels, and loss of limbs and/or their function, in addition to the risks inherent in anesthesia and the use of diverse instruments and equipment itself. It has also been explained to me that these adverse reactions and infrequent, occurring in less than 2% of cases, but they may be aggravated when associated with other patient personal factors, which include underlying diseases, previous heart surgery, prior history of allergies, uncontrolled arterial hypertension, tobacco use, alcoholism, diabetes, obesity, renal insufficiency, cerebrovascular disease, prolonged hospitalization, liver failure, heart disease, atherosclerotic disease, cancer, severe malnutrition, and advanced age, which are the most common. It has also been explained to me that the catheters and prostheses used are subjected to previous tests, but that they may present defects or even fracture, causing adverse reactions and varying types and degrees of injury, including the possibility of requiring surgery to remove them. It has been reiterated to me that no guarantees or assurances are given with respect to the results expected from the proposed procedure. I am aware that, in executing the proposed procedure, the hemodynamicist and his/her team will be present, and it will be possible to solicit the presence of other specialists, as well as observers from the manufacturer of the equipment and material used. My signature at the end of this consent form authorizes the participation of these professionals and grants them 162