Martin Stockburger

Aims: Cardiac Implantable Electronic Devices (CIED) training for novice implanters typically occurs in vivo, varies across countries/institutions, and results in inconsistent skill levels. Proficiency-Based Progression (PBP) simulation training—requiring attainment of expert-derived performance benchmarks before clinical practice—reduced procedural errors by 61–77% compared with traditional simulation-based training (SBT) in randomised simulation trials. This study aimed to quantify clinical skill transfer in CIED implantation for the first time, comparing in vivo deviations from expert-agreed optimal technique in early-career implanters previously randomised to PBP versus SBT. Methods and results: Prospective observational cohort study following participants from a prior multinational randomised simulation trial to assess transfer of training to clinical practice. Early-career implanters (≥20 prior pacemaker/defibrillator cases; limited CRT first-operator experience) reported the implant technique they applied in their first two routine clinical cases within 30 days of training, using a validated standardised performance metrics form assessing surgical and lead implantation steps. The primary outcome was the mean percentage of deviations from optimal technique per participant. Of 30 randomised participants, 21 (70%) submitted 42 case reports (10 PBP, 11 SBT). Baseline characteristics were similar and case complexity did not differ between groups (p = 0.43). PBP trainees demonstrated 60% fewer procedural deviations than SBT trainees (mean [SD], 5.8% [3.8%] vs 14.4% [9.1%]; p = 0.013). Conclusion: Metrics-based PBP training was associated with significantly fewer procedural deviations from optimal CIED implant technique during early clinical practice compared with traditional simulation. These findings support benchmark-based simulation as a strategy to improve early clinical skill transfer in cardiac electrophysiology.

Cardiac implantable electronic devices (CIEDs) are widely used to manage rhythm disorders. However, implanters’ training still follows an apprenticeship model, conducted in vivo from the outset, with wide institutional variability and lacking objective performance criteria to assess competence. Using objective validated metrics, this study evaluated procedural skills of early-career operators licensed to independently perform implantations and explored potential benefits of additional simulation-based training. Fifteen CIED implanters from six European countries underwent a three-task simulation assessment: (1) virtual reality dual-chamber pacemaker lead implantation scored using validated procedural metrics; (2) suture selection for lead fixation; and (3) knot-tying tested for security via tensiometer. Primary outcomes included total procedural errors (All-Errors), correct suture choice, and knot integrity. Performance was benchmarked against expert-defined proficiency standards. A supplementary analysis compared results with prior cohorts trained via traditional simulation-based training (SBT) or proficiency-based progression (PBP) approach. Participants made a median of 7.0 All-Errors (IQR 4.0–8.5) in the implant task, with only 20% meeting proficiency criteria. Correct suture selection occurred in 73%, and 67% tied secure knots. No significant correlation was found between implant experience and All-Errors rate. Compared to study participants, PBP-trained peers made 76% fewer errors (p < 0.001), while SBT training offered no significant advantage. Despite being licensed first operators, most early-career CIED implanters did not meet proficiency benchmarks. These findings highlight limitations in current training and certification. Proficiency-Based Progression may address these gaps by ensuring objectively verified readiness on simulation before in-vivo practice. Future studies should evaluate its impact on clinical outcomes. Graphical abstract

Aims: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training. Methods and results: In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance. Conclusion: Proficiency-based progression training produces superior objectively assessed novice operators’ surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training’s effect on surgery-related device complications.

In cardiac implantable electronic device (CIED) implantations, as in other cardiovascular procedures, therapy outcomes and complication rates seem to correlate with the operator’s level of experience with the given intervention. Furthermore, the impact of the learning curve has been shown for novice physicians attempting an established conventional procedure1 as well as for expert operators adopting a new technique or technology.2 3 Even though a relationship seems to exist between procedure volume and clinical outcomes,4 it is not completely understood how the quality of the implant performance changes with increasing procedure experience volume. Patients should be assured of a verified and measurable quality of treatment that should not vary greatly as a function of physician experience. The European Society of Cardiology has highlighted as a priority across member countries the need for assessing skills more consistently and away from the bedside, rather than counting procedure numbers.5 Training may play a fundamental role in developing the operator’s skills to an established performance level before implementing a new therapy or technology in vivo. Unfortunately, across the world, current procedural training offered to beginners (no matter how senior or experienced) is not consistent; curricula and therapy approaches may vary with the provider and so does the assessment of ‘competence’. Many institutions continue to rely on the traditional apprenticeship model introduced by Halsted more than a century ago, where trainees learn by hands-on experience and education within a hierarchical training programme, on patients, under consultant/attending level of experienced physician/surgeon supervision.6 This approach to training is often unstructured due to patient/supervisor variabilities and lacks performance feedback that is uniform, validated, objective and transparent. Furthermore, it exposes patients to higher risk during trainees’ learning curve (and beyond, if training cannot guarantee a given level of performance).

In vorangehenden Studien zur präventiven Therapie von Patienten mit paroxysmalem Vorhofflimmern (VHF) wurde bifokale rechtsatriale Stimulation (BS) bei gleichzeitiger antiarrhythmischer Therapie als effektive Strategie zur Verlängerung des rezidivfreien Intervalls beschrieben. Die vorliegende Studie vergleicht prospektiv die kumulative Prävalenz von VHF (AF Burden) während unifokaler (US) und bifokaler rechtsatrialer Stimulation unter spiegelkontrollierter Sotaloltherapie. Bei 19 Patienten mit symptomatischer Sinusknotendysfunktion und paroxysmalem Vorhofflimmern wurde ein DDDR-Schrittmachersystem mit einer rechtsatrial lateralen und einer tief septal am Koronarsinusostium platzierten Vorhofsonde implantiert. Eine anhand des Plasmaspiegels kontrollierte Sotaloltherapie wurde begonnen. Nach einer dreimonatigen Phase mit zurückhaltender rein antibradykarder Stimulation (Back-up-Phase) wurden die Patienten für 3 Monate auf kontinuierliche rechtsatrial BS oder US randomisiert. Im Anschluss wurde für weitere 3 Monate der komplementäre Modus programmiert. Primärer Studienendpunkt war AF Burden. Als sekundäre Endpunkte wurden die Anzahl von Episoden, das rezidivfreie Intervall und die Therapiesicherheit definiert. Während der Back-up-Phase trat zu 12,4% der Zeit und während US und BS zu je 6,2% Vorhofflimmern auf. (p = 0,91 US vs. BS, p = 0,08 Back-up vs. US und p = 0,07 Back-up vs. BS, "Intention- to-treat"-Analyse.) Auch die „per-protocol“-Analyse ergab keinen Vorteil für eine der beiden Stimulationskonfigurationen. (US 4,8% und BS 5,4% VHF, p = 0,64). Atriale Stimulation verminderte tendenziell die Vorhofflimmerlast im Vergleich zur Back-up-Phase (US oder BS 6,2% vs. Back-up 8,8%, p = 0,09). Bei 3 Patienten kam es zur Dislokation der atrial septalen Sonde. Atriale Stimulation unter Sotaloltherapie reduziert tendenziell die Vorhofflimmerlast bei Patienten mit Sinusknotendysfunktion und paroxysmalem VHF. Ein zusätzlicher präventiver Effekt von BS vs. US kann nicht bestätigt werden. Rechtsatrial BS ist möglicherweise mit einer höheren Sondendislokationsrate verbunden. Bifocal right atrial pacing (BP) has been reported to increase arrhythmia-free intervals in patients with paroxysmal atrial fibrillation (PAF) under antiarrhythmic drugs. This study compares AF burden with unifocal pacing (UP) vs BP under sotalol. In 19 patients with PAF a DDDR pacemaker with right atrial lateral and CS ostial leads was implanted. Sotalol was initiated. After a 3 month back-up pacing period patients were randomized to continuous UP or BP for 3 months and crossed over for 3 more months. Primary endpoint was AF burden. Secondary endpoints included number of episodes, time to first recurrence and safety of BP. The intention to treat analysis revealed 12.4% AF during back-up, 6.2% during UP and BP (p = 0.91 UP vs BP, p = 0.08 back-up vs UP and p = 0.07 back-up vs BP). Per protocol analysis showed no advantage of either pacing mode (UP 4.8% and BP 5.4% AF, p=0.64). Overdrive pacing reduced AF burden to 6.2 vs 8.8% during back-up (p=0.09). Septal lead dislodgement occurred in 3 patients. Atrial pacing tends to reduce AF burden in patients with PAF under sotalol. An incremental effect of BP vs UP cannot be confirmed. BP may be complicated by elevated lead dislodgement rates.

M. Stockburger, H. Langreck, S. Rolf, W. Haverkamp, R. Dietz; A38-2 Possible hemodynamic impairment by conventional right ventricular pacing: How many patients

M. Stockburger, H. Langreck, S. Rolf, W. Haverkamp, R. Dietz; A38-2 Possible hemodynamic impairment by conventional right ventricular pacing: How many patients