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 7 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE PROCEDURE OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) 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(s), who are completely identified below, as well as the team known as the “Heart Team,” composed of a clinical cardiology, cardiovascular surgeon, and interventional cardiologist, all the information, 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 procedure transcatheter aortic valve implantation (TAVI) 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 one of the signing physicians: the aim of this procedure is to treat narrowing or severe stenosis of the aortic valve by means of transcatheter implantation of a biological prosthesis. The valve is positioned using a delivery system. This delivery system helps position the process through the narrow aortic valve. With the heart beating, the prosthesis is released in the site, pushing the leaflets of the diseased valve against the aorta. The new prosthesis will, thus, function in the place of the valve that was diseased, without requiring the latter’s removal. The delivery system is removed and some tests are performed before closing the small incision in the inguinal region. In addition to angiography, the procedure is guided by echocardiography. Depending on each case, dilation may be performed with a special balloon catheter before or after release of the prosthesis. A temporary pacemaker lead will be placed in the right ventricle and it may remain in the patient after the procedure if indicated by the physician. 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 5% 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. These risks, however, are less than 1%. 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 possible consequences of not performing the suggested treatment, as well as the possible existence of alternative procedures, 170