Most cited article - PubMed ID 35127877
Robotic Cardiac Surgery in Europe: Status 2020
Robotic coronary and intra-cardiac surgery has been available for more than 25 years. In this period, multiple studies have demonstrated the beneficial effects of robotic surgery over conventional open surgery. Throughout the years, technical developments have enabled us to perform totally endoscopic coronary artery bypass (TECAB) grafting. But these techniques remained in the hands of a small group of pioneers because of a lack of structured training programs and the absence of long-term results at that time. Currently, a renewed interest and a wide dispersion of robotic platforms, thanks to use of robotics in other disciplines, has led to an exponential increase in robotic cardiac centers both in Europe and USA. Nonetheless, this increase was slowed down in Europe as a result of the uncertainty introduced by the implementation of a revised regulatory framework for medical devices [Regulation 2017/745, 'Medical Device Regulation' ('MDR')]. The MDR was introduced with the goal of increasing patient safety and supporting innovation. Implementing the MDR has proven to be exceptionally challenging and risks to the supply of essential devices have been identified. Changes to both regulatory and market dynamics led to a circumstance where the only available robotic platform for cardiac surgery decided to cease marketing of essential accessories for conducting surgery. This resulted in the disappearance of dedicated tools such as the Endowrist stabilizer, essential for TECAB, and the atrial retractor which is essential for intra-cardiac surgery. In the mean-time, further clinical evidence was published demonstrating the superiority of robotic cardiac surgery over other minimally invasive approaches. This has demonstrated the need to better define the clinical evidence requirements for regulatory purposes to ensure that dedicated tools for evidence-based interventions in robotic coronary surgery remain available such that TECAB can continue in Europe.
OBJECTIVE: This study aimed to investigate the validity of simulation-based assessment of robotic-assisted cardiac surgery skills using a wet lab model, focusing on the use of a time-based score (TBS) and modified Global Evaluative Assessment of Robotic Skills (mGEARS) score. METHODS: We tested 3 wet lab tasks (atrial closure, mitral annular stitches, and internal thoracic artery [ITA] dissection) with both experienced robotic cardiac surgeons and novices from multiple European centers. The tasks were assessed using 2 tools: TBS and mGEARS score. Reliability, internal consistency, and the ability to discriminate between different levels of competence were evaluated. RESULTS: The results demonstrated a high internal consistency for all 3 tasks using mGEARS assessment tool. The mGEARS score and TBS could reliably discriminate between different levels of competence for the atrial closure and mitral stitches tasks but not for the ITA harvesting task. A generalizability study also revealed that it was feasible to assess competency of the atrial closure and mitral stitches tasks using mGEARS but not the ITA dissection task. Pass/fail scores were established for each task using both TBS and mGEARS assessment tools. CONCLUSIONS: The study provides sufficient evidence for using TBS and mGEARS scores in evaluating robotic-assisted cardiac surgery skills in wet lab settings for intracardiac tasks. Combining both assessment tools enhances the evaluation of proficiency in robotic cardiac surgery, paving the way for standardized, evidence-based preclinical training and credentialing. CLINICAL TRIAL REGISTRY NUMBER: NCT05043064.
- Keywords
- assessment, robotic cardiac surgery, simulation, validity, wet lab,
- Publication type
- Journal Article MeSH
- MeSH
- Cardiac Surgical Procedures * adverse effects MeSH
- Humans MeSH
- Mitral Valve diagnostic imaging surgery MeSH
- Mitral Valve Insufficiency * diagnostic imaging surgery MeSH
- Robotic Surgical Procedures * adverse effects MeSH
- Robotics * MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- MeSH
- Humans MeSH
- Specialties, Surgical * MeSH
- Forecasting MeSH
- Myocardial Revascularization MeSH
- Robotic Surgical Procedures * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
BACKGROUND: Robotic assistance (RA) in the harvesting of internal thoracic artery during minimally invasive direct coronary artery bypass grafting (MIDCAB) provides several potential benefits for surgeon and patient in comparison with conventional MIDCAB. The two technical options have not been thoroughly compared in the literature yet. We aimed to perform this in our cohort with the use of propensity-score matching (PSM). METHODS: This was a retrospective comparison of all consecutive patients undergoing conventional MIDCAB (2005-2021) and RA-MIDCAB (2018-2021) at our institution with the use of PSM with 27 preoperative covariates. RESULTS: Throughout the study period 603 patients underwent conventional and 132 patients underwent RA-MIDCAB. One hundred and thirty matched pairs were selected for further comparison. PSM successfully eliminated all preoperative differences. Patients after RA-MIDCAB had lower 24 h blood loss post-operatively (300 vs. 450 ml, p = 0.002). They had shorter artificial ventilation time (6 vs. 7 h, p = 0.018) and hospital stay (6 vs. 8 days, p < 0.001). There was no difference in the risk of perioperative complications, short-term and mid-term mortality between the groups. CONCLUSIONS: RA-MIDCAB is an attractive alternative to conventional MIDCAB. It is associated with lower post-operative blood loss and potentially faster rehabilitation after surgery. The mortality and the risk of perioperative complications are comparable among the groups.
- Keywords
- MIDCAB, coronary artery bypass grafting, internal thoracic artery, minimally invasive surgery, robotic surgery,
- Publication type
- Journal Article MeSH
