ABC | Volume 113, Nº5, November 2019

Guidelines Guideline of the Brazilian Society of Cardiology on Telemedicine in Cardiology – 2019 Arq Bras Cardiol. 2019; 113(5):1006-1056 ARTEMIS was the first surgical robot used for cardiac procedures. 194 Designed as a telesurgery and telepresence system for cardiac procedures, it was used for training and planning and to perform minimally invasive procedures. Currently, robotic cardiac surgery has been used primarily for mitral valve repair and myocardial revascularization, following approval by the Food and Drug Administration (FDA) in 2002 and 2000, respectively. Newer techniques assist in cardiac manipulation procedures by compensating heart movements. However, large-scale implementation of this technique is hampered by its high cost 195 and the absence of randomized studies demonstrating its superiority over traditional minimally invasive techniques, with or without hybrid procedures. 196 The first robotic mitral valve heart surgery was performed in 1998 by Carpentier, in France, and Mohr, in Germany. That same year, Carpentier conducted the first coronary artery bypass surgery in Paris, while Reichenspurner performed revascularization surgery with the voice-controlled ZEUS Robotic Surgical System (Computer Motion, Goleta, CA) inMunich. 196,197 Since then, this technique has become popular as it is associated with less surgical aggression, reduced cardiopulmonary bypass and aortic clamping duration, and shorter hospital stay compared with the conventional open technique. 197 The da Vinci® robotic system has allowed improved visualization of the surgical field with three-dimensional capture and ten-fold magnification, resulting in greater precision in the surgical procedure and smaller incisions following a learning curve. 198,199 It has also reduced the rates of all complications (particularly infection), blood transfusion, and time to return to work activities, with an impact on the total costs of the procedure. This has been observed especially among patients at high risk (like elderly individuals) and those with ejection fraction lower than 20%, diabetes of difficult control, and severe chronic obstructive pulmonary disease. 200 This robotics system has also benefited hybrid surgeries, angioplasty, and minimally invasive procedures in patients with multilateral obstructive coronary artery disease. 201 Both computer-integrated surgery and telemedicine are becoming popular in the developed world. Advancements in robotic technology and information technology, like the Internet of Things, allow robotic arms to be controlled remotely, enabling robotic telesurgery. With telesurgery, surgeons can perform surgical procedures in remote locations, away from the patients, improving the access to medical treatment and, potentially, the quality of the treatment. As with other telemedicine applications, telesurgery can broaden the access to interventions in remote areas or centers where specialists in particular types of surgery are not present, for example. The importance of telemedicine, telesurgery, and remote surgery is not restricted to their ability to perform medical procedures in areas where these procedures are not available and can be extended to telementoring, which involves the training of medical professionals to perform these procedures. 202 In this area, telesurgery could also benefit patients requiring infrequent, highly complex interventions, in which the medical-surgical expertise is not widely available. The acquisition of new technology expertise by specialists has been accompanied by mentoring programs (proctors). In robotic surgery, telemedicine can provide training with remotely connected proctors (telementoring), expanding the access to innovative technologies. 203,204 Outcomes of robotic surgeries still lack long-term analyses of hard outcomes like all-cause mortality, cardiovascular death, fatal AMI, stroke, need for repeat revascularization, and vascular graft patency. As in traditional surgeries, patient selection is essential, and the goal should be complete revascularization, bearing in mind that CO 2 insufflation decreases venous return by increasing intrathoracic pressure and may compromise hemodynamic parameters in patients with left ventricular dysfunction and in those with chronic obstructive disease, who would benefit more fromminimally invasive surgery. Case series have been reported totaling about 110 patients and showing 90% of surgical success within 30 days without open surgery and a maximum follow-up of 5 years. 205-207 The largest experience in this area has been published by Cavallaro et al., 208 who reported rates of morbidity and mortality with robotic myocardial revascularization surgery in 2,582 patients between 2008 and 2010. The authors reported lower rates of postoperative complications in selected patients but concluded that these benefits decreased in patients requiring multiple bypass grafts. 208 Approximately 1,700 robotic heart surgeries are performed annually in the US, including 35.5% for mitral valve repairs. 209 In 2011, the FDA introduced a post-marketing surveillance plan known as the Medical Device Epidemiology Network initiative, leveraging AI to real-world data analysis, including international registries and electronic medical record data, to bridge the gap in evidence gathering concurrent with the implementation of technological innovation without compromising patient safety. 210 In Brazil, none of the robotic surgical techniques have been included in the public policy list or in the List of Procedures and Events in Health of the National Health Agency. 210 In this sense, the CFM, through Resolution 2.227/2018, which was later repealed, had regulated robotic telesurgery, precisely anticipating the expansion of the benefits of the technique and facilitating the follow-up of the learning curve by proctors in remote locations. Thus, robotic surgery in Brazil can be remotely assisted by a specialist at a large center in another country. Although the CFM allowed the use of robotic telesurgery in Brazil, it restricted the method to professionals qualified to practice medicine in the country. 39 Of note, mentoring/proctoring programs in Brazil have not been widely regulated, except in the State of Paraíba, where the CRM, through Resolution CRM-PB 182/2018, defined rules that regulate and legally secure the practice to the medical act. 39 In addition to the information presented above, synchronization between the vast potential of these technologies and the existing ethical and legal apparatus is also lacking. Unlike a comprehensive national policy, there is a general scenario of fragmentation characterized by different norms and standards issued by different agencies and with a different focus. 7 Even if a single instrument could hardly achieve these objectives, fragmentation would be yet another obstacle to overcome to reach the potential that telemedicine and telesurgery have in our country. 1033