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 14 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE PROCEDURE OF ANGIOPLASTY WITH RENAL ARTERY STENT IMPLANTATION 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 angioplasty with renal artery stent implantation 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 treat obstructions or blocks in the renal artery, clearing the obstruction by inflating a small balloon catheter in the site of the block, followed by implantation of a metallic mesh called a stent, via percutaneous access. The procedure is performed by means of a puncture in the femoral artery in the inguinal region, into which a catheter is introduced close to the diseased renal artery. X-ray emitting equipment and iodized contrast are used to identify the block in the artery. A very small guidewire will cross the obstruction, allowing for positioning of the balloon catheter in the block. Subsequently, a stent will be positioned and released in the site. Finally, renal arteriography will be performed as final angiographic control. 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 possible consequences of not performing the suggested treatment, as well as the possible existence of alternative procedures, and my doubts have been satisfactorily addressed and answered. I am aware that there is a possibility of alteration of the original procedure over the course of the aforementioned procedure and/or new procedure or surgery for the sake of continuity of 184