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 2 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE EXAM/PROCEDURE OF CORONARY CINEANGIOGRAPHY WITH LEFT VENTRICULOGRAPHY, FFR, OR IFR AND ASSESSMENT OF MYOCARDIAL BRIDGING 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 exam/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 exam/procedure cineangiography with left ventriculography, intracoronary ultrasound (ICUS), fractional flow reserve (FFR), or instantaneous free-wave ratio (iFR) and assessment of myocardial bridging 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 aim of this exam/procedure is to facilitate diagnosis of obstructions or blocks in arteries that irrigate or supply the cardiac muscle, known as coronary arteries. The exam/procedure consists of the insertion of a fine catheter through an arterial puncture, generally in the inguinal region or the radial artery. Exceptionally, it may be done by dissection/puncture of the brachial artery. Using this fine catheter, iodized contrast, and X-rays, it will be possible to understand the anatomy of the coronary arteries and, consequently, the extent of blocks which limit the free flow of blood to supply the heart, if they are present. In the event of doubts regarding the significance of the coronary artery blocks found, ICUS may be performed through a microcatheter specifically dedicated to this purpose, which will be introduced into the obstructed coronary artery. Diagnostic clarification regarding the severity of the coronary obstruction or block may be further carried out by means of the introduction of a very fine guidewire inside the coronary artery; this is known as FFR or iFR. I declare that, in the manner explained to me by the physician, I am perfectly able to understand what the exam/procedure which I am to undergo will comprise. I declare that I am aware that the intended purpose of performing the forenamed exam/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 exam/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 exam/procedure. I am aware that, in executing the proposed exam/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 full access to records and medical information related to my case. I have also been informed that, should it be necessary, bed restraint may be performed, as prescribed by the physician, and that I will be under the surveillance of the nursing staff. 160