The evolution of technical prerequisites and local boundary conditions for optimization of mitral valve interventions-Emphasis on skills development and institutional risk performance.

This viewpoint report describes how the evolution of transcatheter mitral valve intervention (TMVI) is influenced by lessons learned from three evolutionary tracks: (1) the development of treatment from mitral valve surgery (MVS) to transcutaneous procedures; (2) the evolution of biomedical engineering for research and development resulting in predictable and safe clinical use; (3) the adaptation to local conditions, impact of transcatheter aortic valve replacement (TAVR) experience and creation of infrastructure for skills development and risk management. Thanks to developments in computer science and biostatistics, an increasing number of reports regarding clinical safety and effectiveness is generated. A full toolbox of techniques, devices and support technology is now available, especially in surgery. There is no doubt that the injury associated with a minimally invasive access reduces perioperative risks, but it may affect the effectiveness of the treatment due to incomplete correction. Based on literature, solutions and performance standards are formulated with an emphasis in technology and positive outcome. Despite references to Heart Team decision making, boundary conditions such as hospital infrastructure, caseload, skills training and perioperative risk management remain underexposed. The role of Biomedical Engineering is exclusively defined by the Research and Development (R&D) cycle including the impact of human factor engineering (HFE). Feasibility studies generate estimations of strengths and safety limitations. Usability testing reveals user friendliness and safety margins of clinical use. Apart from a certification requirement, this information should have an impact on the definition of necessary skills levels and consequent required training. Physicians Preference Testing (PPT) and use of a biosimulator are recommended. The example of the interaction between two Amsterdam heart centers describes the evolution of a professional ecosystem that can facilitate innovation. Adaptation to local conditions in terms of infrastructure, referrals and reimbursement, appears essential for the evolution of a complete mitral valve disease management program. Efficacy of institutional risk management performance (IRMP) and sufficient team skills should be embedded in an appropriate infrastructure that enables scale and offers complete and safe solutions for mitral valve disease. The longstanding evolution of mitral valve therapies is the result of working devices embedded in an ecosystem focused on developing skills and effective risk management actions.

At the Crossroads of Minimally Invasive Mitral Valve Surgery-Benching Single Hospital Experience to a National Registry: A Plea for Risk Management Technology.

Almost 30 years after the first endoscopic mitral valve repair, Minimally Invasive Mitral Valve Surgery (MIMVS) has become the standard at many institutions due to optimal clinical results and fast recovery. The question that arises is can already good results be further improved by an Institutional Risk Management Performance (IRMP) system in decreasing risks in minimally invasive mitral valve surgery (MIMVS)? As of yet, there are no reports on IRMP and learning systems in the literature. (2) Methods: We described and appraised our five-year single institutional experience with MIMVS in isolated valve surgery included in the Netherlands Heart Registry (NHR) and investigated root causes of high-impact complications. (3) Results: The 120-day and 12-month mortality were 1.1% and 1.9%, respectively, compared to the average of 4.3% and 5.3% reported in the NHR. The regurgitation rate was 1.4% compared to 5.2% nationwide. The few high-impact complications appeared not to be preventable. (4) Discussion: In MIMVS, freedom from major and minor complications is a strong indicator of an effective IRMP but remains concealed from physicians and patients, despite its relevance to shared decision making. Innovation adds to the complexity of MIMVS and challenges surgical competence. An IRMP system may detect and control new risks earlier. (5) Conclusion: An IRMP system contributes to an effective reduction of risks, pain and discomfort; provides relevant input for shared decision making; and warrants the safe introduction of new technology. Crossroads conclusions: investment in machine learning and AI for an effective IRMP system is recommended and the roles for commanding and operating surgeons should be considered.

The Impact of Biomedical Engineering on the Development of Minimally Invasive Cardio-Thoracic Surgery.

(1) We describe the boundary conditions for minimally invasive cardiac surgery (MICS) with the aim to reduce procedure-related patient injury and discomfort. (2) The analysis of the MICS work process and its demand for improved tools and devices is followed by a description of the relevant sub-specialties of bio-medical engineering: electronics, biomechanics, and materials sciences. (3) Innovations can represent a desired adaptation of an existing work process or a radical redesign of procedure and devices such as in transcutaneous procedures. Focused interaction between engineers, industry, and surgeons is always mandatory (i.e., a therapeutic alliance for addressing 'unmet patient or professional needs'. (4) Novel techniques in MICS lean heavily on usability and safe and effective use in dedicated hands. Therefore, the use of training and simulation models should enable skills selection, a safe learning curve, and maintenance of proficiency. (5) The critical technical steps and cost-benefit trade-offs during the journey from invention to application will be explained. Business considerations such as time-to-market and returns on investment do shape the cost-benefit room for commercial use of technology. Proof of clinical safety and effectiveness by physicians remains important, but establishing the technical reliability of MICS tools and warranting appropriate surgical skills come first.