From Impression to Evidence: Proficiency-Based Progression for Cardiac Device Implanters | E11 Dr Jorio Mascheroni

Guest: Dr Jorio Mascheroni, biomedical engineer, with a Master's in Technology Enhanced Learning and a PhD on how best to implant cardiac resynchronisation therapy (CRT) devices. Jorio has spent his career in the medical device industry, where he develops and validates training for cardiac device implanters.  Interviewed by: Professor Anthony G. Gallagher  Topic: Moving the Learning Curve Away from the Patient: Proficiency-Based Progression for Cardiac Device Implantation  Episode Summary  Professor Tony Gallagher talks with Dr Jorio Mascheroni, a friend and collaborator of around 20 years, about a career spent trying to make device training safer and more effective. Jorio was there when cardiac resynchronisation therapy was introduced and saw early on that getting specific steps right, and avoiding specific mistakes, decided whether a procedure went well.  The conversation traces how training moved from knowledge-based courses and "learning on patients", through the early days of virtual reality simulators, to a proficiency-based progression (PBP) programme with validated metrics and a benchmark that every trainee must reach before moving on. Jorio shares what his randomised trials found, why the approach does not take longer or cost more over time, and why he would change one thing above all: everyone should start in a protected environment and only then move to the operating room.  Key Topics Covered  Introducing Dr Jorio Mascheroni (0:00)  An engineer who moved into education, with a Master's in Technology Enhanced Learning and a PhD on optimal CRT implantation Twenty years of working together From Engineer to Educator: The Arrival of CRT (0:34)   Witnessing the introduction of cardiac resynchronisation therapy, a completely new type of procedure Working with the pioneers and realising that performing certain steps properly and avoiding mistakes determined success Early involvement in building a virtual reality simulator for CRT, and the chance to move training away from the patient Training 25 Years Ago: Impression, Not Data (2:55)   Training was mostly knowledge-based and theoretical Physicians learning a new procedure were, and still often are, learning on patients Different experts taught different content and techniques for the same procedure Nobody measured what trainees had actually learned: "we had an impression that people were getting better" Simulators: From Room Decoration to a Standard Workflow (6:51) Early simulators were often "the attraction of the training event" Use ranged from decoration to the first attempts at standardising a procedural workflow Bringing the pioneers together to agree an optimal approach, and why a group of experts beats a single speaker telling their own story Was Simulation Seen as a Magic Bullet? (10:04) Industry valued simulation for demonstrating product workflow in a safe setting Effectiveness depended on the faculty delivering the training "Simulators by themselves don't teach much if there is no solid curriculum around" Shared Shortcomings Across Industry and Medicine (11:54) Underestimating the size of skill gaps and taking foundational skills for granted Training differed from one hospital to the next, even for the same therapy Speaker-centred training: "listening to an expert does not mean that you become an expert" Learning curves happening on patients in the clinical environment An Accumulation of Evidence (15:04) No single turning point: evidence built up that different techniques produced different patient outcomes The way you teach someone to do something may determine the outcome for the patient Reading Tony's work on minimally invasive surgery and realising the approach could apply to device implantation The aggregation of marginal gains, and why it sits at the core of proficiency-based progression Related reading: Gallagher AG, Ritter EM, Champion H, et al. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Annals of Surgery, 2005; 241(2): 364 to 372   What Pacing and CRT Are (21:22) Treatments for selected patients with cardiac rhythm abnormalities A generator placed under the skin of the chest, connected to the heart through implanted leads Permanent pacing has been around for about 70 years; CRT for 25 to 30 years Where Device Training Fell Short (23:41) Challenge one: training or coaching in the cath lab is too late, and it is not fair for the learning curve to happen on a patient Challenge two: many interpretations of optimal implantation, never compared, varying between countries and even neighbouring hospitals Licensed physicians finishing training with wide variability in performance Complications that looked like technology problems were often a suboptimal use of the technology Tony on the surgical side of device procedures: femoral access complications in carotid stenting at Emory in 2003, and the same complications two decades later with TAVR Publication: Mascheroni J, Stockburger M, Patwala A, Retzlaff H, Gallagher AG. Beyond the badge: quantitative insights of skill gaps in licensed early-career cardiac device implanters and evidence-based pathways to proficiency. Journal of Interventional Cardiac Electrophysiology, 2026; 69: 267 to 276. Most licensed early-career implanters did not meet the proficiency benchmark on a simulated assessment.   What a PBP Programme for Device Implantation Involves (28:26)   A structured, consensus-based description of how the procedure should be performed Metrics, and a proficiency benchmark set from experienced operators A blended curriculum: trainees must pass a knowledge benchmark before hands-on training Faculty training is critical: "If you stick to the methodology the results are generally very predictable" Publication: Mascheroni J, Mont L, Stockburger M, Patwala A, Retzlaff H, Gallagher AG, et al. International expert consensus on a scientific approach to training novice cardiac resynchronization therapy implanters using performance quality metrics. International Journal of Cardiology, 2019; 289: 63 to 69. Experts broke the procedure into 13 phases, 196 steps, 122 errors and 50 critical errors, agreed through a Delphi process with an international panel.   Why Validation Matters, and How Trainees Respond (31:44) Validation makes the approach objective, so it is not "the opinion of 10 people" The metrics must be objective, transparent and fair for trainers and trainees Trainees have responded very positively because they know exactly what is expected "Proficiency-based progression is not meant to fail people": it gives each person the time they need to reach the benchmark The assessment exists to give explicit, formative feedback; reaching the benchmark is non-negotiable What the Data Show (38:44) PBP-trained implanters made significantly fewer errors than peers trained on the same simulators with the same content using traditional methods J...