Seguridad y eficacia de los sistemas robóticos integrados para la realización de procedimientos coronarios

Introduction Cardiovascular diseases (CVD) comprise a group of illnesses that affect the heart and blood vessels, standing as the leading cause of morbidity and mortality in both developed and developing countries. In Spain, they constitute the primary cause of death, with coronary disease being the most prevalent. The treatment of coronary disease involves managing risk factors, using medications, and performing percutaneous or surgical revascularization of affected coronary arteries. However, coronary interventional procedures have remained relatively unchanged for decades, exposing operators and patients to radiation-related risks. In response to these challenges, robotic technology, such as Corindus® CorPath GRX®, has been developed to enhance precision and reduce risks associated with coronary interventional procedures. Robotic technologies offer an alternative to traditional manipulation during coronary procedures, enabling physicians to perform interventions from a radiation-protected cabin, thereby reducing cumulative radiation exposure and improving occupational safety. Moreover, they provide increased precision and control during procedures, potentially leading to better outcomes for patients. Objective The objective is to evaluate the safety, effectiveness and efficiency of integrated robotic systems for performing coronary procedures. Methods A systematic literature search was conducted in the following reference databases up to May 2023: Medline, EMBASE, Cochrane Library, WOS, ECRI, Inspec and CINAHL. The websites of NICE, CADTH, HIS, HIQA, AHRQ, RedETS and NHS EED, ClinicalTrials.gov, ISRCTN Registry y CEA Registry were also explored. Two independent researchers performed the selection of studies and analyzed their quality. The synthesis of results was carried out both quantitatively and qualitatively. The quality of the studies was assessed using the AMSTAR-2 tools for systematic reviews and ROBINS-I for clinical trials. Results Five systematic reviews providing information on the effectiveness and safety of integrated robotic systems for coronary procedures were identified and analyzed, all with critically low quality. Additionally, nine non-randomized clinical trials with high or moderate risk of bias were examined. In terms of efficacy/effectiveness, five studies reported technical success rates of RICP, with an average of 85.8 %. The meta-analysis results indicated no significant difference in clinical success rates and total procedure time between R-PCI and M-PCI. Regarding safety, all included studies analyzed safety variables such as major adverse cardiac events (MACE), all-cause mortality, myocardial infarction, stroke, contrast media usage, fluoroscopy time, operator and assistant radiation dose, and patient radiation dose. The meta-analysis showed no significant differences between R-PCI and M-PCI groups in terms of MACE, all-cause mortality, and myocardial infarction. It revealed a significant reduction in radiation exposure, fluoroscopy time, and contrast media usage during R-PCI procedures compared to M-PCI. However, these differences in fluoroscopy time and contrast media usage were not observed in subgroup analysis for the CorPath 200 system compared to M-PCI. Nevertheless, a favorable effect of R-PCI with the CorPath GRX system was evident in relation to these variables. No studies were identified, whether short or long-term, examining the consequences of radiation exposure or orthopedic injuries associated with coronary procedures. Conclusions The integrated robotic system R-PCI can achieve a clinical success rate and total procedure time similar to the reference technique M-PCI in coronary procedures. In terms of safety, no differences were observed between M-PCI and R-PCI when measuring major adverse cardiac events (MACE), all-cause mortality, and myocardial infarction. Furthermore, it was highlighted that the use of contrast media and fluoroscopy time were significantly lower in R-PCI groups compared to M-PCI, which could be associated with an improvement in the clinical outcomes of patients. However, this contrast usage benefit did not persist when analyzing subgroups with the CorPath 200 robotic system. Additionally, a reduction in radiation exposure during coronary procedures was observed with the use of R-PCI. Nevertheless, the need for short and long-term randomized clinical trials comparing manual PCI with robotic-assisted PCI is emphasized.