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 8 FREE AND INFORMED CONSENT AND AUTHORIZATION FORM FOR PERFORMANCE OF THE PROCEDURE OF ALCOHOL SEPTAL ABLATION 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 alcohol septal ablation 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 procedure is to reduce significant muscular thickening in the interventricular septum (which separates the left and right ventricles) by means of alcoholization of the septal artery accessed by puncture of an artery in the inguinal region. Subsequently, a catheter is selectively placed in the left coronary artery. Through this catheter a very small guidewire is positioned in the first septal branch of the anterior descending coronary artery. This guidewire will allow for the correct positioning of a catheter specifically dedicated to this purpose, which has a small balloon on its end. This balloon will be inflated, closing the septal branch in its proximal portion and, then, one to two milliliters of absolute alcohol or other liquid substances or mechanical microdevices will be administered through the balloon catheter to the distal end of the septal branch. The alcohol or other agents will provoke direct damage to the thickened muscle of the interventricular septum, which, during the course of weeks or even months, will reduce in volume. From that moment onward, the mitral valve will function better and the pressure in the left ventricle will be reduced, which will result in improvements to symptoms of cardiac insufficiency. 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 am also aware that it may take weeks or months for the interventricular septum to become reduced and for me to observe the complete benefit of this procedure. A temporary pacemaker lead may be placed in the right ventricle through the venous access in the inguinal region. Echocardiogram may be performed during the procedure in accordance with the medical team’s indications. 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 approximately 2% to 8% 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 172