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 10 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE PROCEDURE OF INTERATRIAL COMMUNICATION CLOSURE OR OCCLUSION 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 interatrial communication closure or occlusion will be performed in the hemodynamics laboratory of this hospital institution (corporate name ................................................... ..........................................., CNPJ/MF no. ...................................headquarters....................................................................) and that it consists of a puncture in the skin of the patient 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 procedure is to repair abnormal communication of a small opening (orifice) located in the septum that separates two cavities of the heart (right and left atria), known as interatrial communication (IAC). The procedure consists of the introduction of a specific catheter in the inguinal region or groin. This procedure has been recommended by a multidisciplinary team of specialists for patients who have clinical and anatomical characteristics favorable to this approach. The placement of a device similar to an “umbrella” or a spring, known as a prosthesis for IAC closure, occurs by means of the insertion of a catheter in a vein in the inguinal region to the left atrium of the heart, through the IAC. The entire procedure is guided by X-ray and mainly by transesophageal echocardiography, which will aid the medical team in the correct positioning and safe release of the prosthesis in the IAC. Once the device has been successfully released, the catheter will be removed and maneuvers will be performed to contain eventual bleedings in the puncture site, and the procedure will subsequently be concluded. 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 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. I further declare that I have had the opportunity to read this document carefully and also to listen attentively to the physician’s reading of all the information presented herein, and I was able to clarify all of my doubts regarding the risks involved and the 176