International expert consensus on a scientific approach to training novice cardiac resynchronization therapy implanters using performance quality metrics

Aims: Pacing and Cardiac Resynchronization Therapy (CRT) procedural training for novice operators usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee ability to perform required tasks at predetermined performance levels prior to in-vivo practice. We sought to characterize and validate with experts a reference approach to pacing/CRT implants based on objective and explicit performance quality metrics, for the development of a reproducible, simulation-based, training curriculum aiming to operator proficiency. Methods: Three experienced CRT implanters, a behavioural scientist and two engineers performed a detailed task deconstruction of the pacing/CRT procedure and identified the performance metrics (phases, steps, errors, critical errors) that constitute an optimal CRT implant for training purposes. The metrics were stress tested to determine reliability and score-ability and then subjected to detailed systematic review by an international panel of 15 expert implanters in a modified Delphi process. Results: Thirteen procedure phases were identified, consisting of 196 steps, 122 errors, 50 critical errors. The expert panel deliberation added 16 metrics, deleted 12, and modified 43. Unanimous panel consensus on the resulting CRT procedure metrics was obtained, which verified face and content validity. Conclusion: A reference pacing/CRT procedure and metrics created by a core group of experts accurately characterize the essential components of performance and were endorsed by an international panel of experienced peers. The metrics will underpin quality-assured novice implanter training

International expert consensus on a scientific approach to training novice cardiac resynchronization therapy implanters using performance quality metrics

Aims: Pacing and Cardiac Resynchronization Therapy (CRT) procedural training for novice operators usually takes place in-vivo and methods vary across countries/institutions. No common system exists to objectively assess trainee ability to perform required tasks at predetermined performance levels prior to in-vivo practice. We sought to characterize and validate with experts a reference approach to pacing/CRT implants based on objective and explicit performance quality metrics, for the development of a reproducible, simulation-based, training curriculum aiming to operator proficiency. Methods: Three experienced CRT implanters, a behavioural scientist and two engineers performed a detailed task deconstruction of the pacing/CRT procedure and identified the performance metrics (phases, steps, errors, critical errors) that constitute an optimal CRT implant for training purposes. The metrics were stress tested to determine reliability and score-ability and then subjected to detailed systematic review by an international panel of 15 expert implanters in a modified Delphi process. Results: Thirteen procedure phases were identified, consisting of 196 steps, 122 errors, 50 critical errors. The expert panel deliberation added 16 metrics, deleted 12, and modified 43. Unanimous panel consensus on the resulting CRT procedure metrics was obtained, which verified face and content validity. Conclusion: A reference pacing/CRT procedure and metrics created by a core group of experts accurately characterize the essential components of performance and were endorsed by an international panel of experienced peers. The metrics will underpin quality-assured novice implanter training

Atrioventricular synchronous pacing in hypertrophic obstructive cardiomyopathy

Atrioventricular synchronous pacing in hypertrophic obstructivecardiomyopathy Fredrik Gadler Department of Cardiology, Karolinska hospital, Stockholm, Sweden The study addresses major issues of cardiac pacing in hypertrophic obstructivecardiomyopathy (HOCM). The influence of ventricular pacing site and atrioventncular(AV)-delay on left ventricular outflow tract (LVOT) gradient. The long-term effectsof pacing in HOCM patients with provocable LVOT obstruction only and radiofrequencymodification of AV-conduction as adjunct therapy to optimise pacing. Furthermorethe influence of pacing on septal structure and any lasting effects of pacing followingcessation of pacing and the impact of long-term pacing on quality of life in HOCMpatients. Measurements were made in 15 patients of LVOT gradient and cardiac output at anumber of AV-delays during septal and apical right ventricular stimulation and sinusrhythm. Apical stimulation reduced the LVOT > 30% in all subjects whereas septalstimulation reduced LVOT gradient in only three subjects. Cardiac output did notdiffer between conditions. These data support that an apical stimulation site isof crucial importance for successful pacing in HOCM. A comparison between 19 patients with provocable LVOT gradient only and 22 subjectswith resting LVOT gradients was made after a pacing duration of at least six months.Symptomatology improved to a comparable extent in both groups in parallel with increasedexercise capacity in the majority of subjects. Thus, patients who only exhibit significantLVOT obstruction during provocation benefit as much from pacemaker treat ment aspatients who already have significant obstruction at rest, both acutely and long-term. Six patients with rapid native AV-conduction and refractory to pacing, due tolack of full apical preexcitation underwent radiofrequency modification of the AV-node.Significant lasting prolongation of AV-conduction and full apical preexcitation wasachieved in five subjects, one subject developed complete AV-block after one month.During one year of follow up a significant decrease in LVOT obstruction and symptomatologywas observed. Thus, radiofrequency modification of AV-conduction enhances effectsof pacing in HOCM patients in whom it is difficult to achieve full apical preexcitation. Ten patients successfully paced for a mean of 19 months were randomised to eitherthree months of continued or discontinued pacing. No patient completed the full threemonths of inactive pacing due to retum of intolerable symptoms in parallel with increasedLVOT obstruction. Pacing does not seem to induce lasting effects after cessation,at least not to a degree positively influencing hemodynamics and symptomatology. Quality of life was studied in 82 patients randomised to each three months ofactive or inactive pacing. After the crossover study, a six month period of preferredpacing mode followed. Seventy-six patients preferred active pacing at the end ofthe crossover period. Active pacing induced profound positive changes in almost allareas of quality of life. Pacing has beneficial effects on hemodynamics as well as quality of life in patientswith hypertrophic obstructive cardiomyopathy also in patients with LVOT gradientduring provocation only. To achieve these effects an apical pacing site with an individualoptimised atrioventricular delay is of crucial importance. Radiofrequency modificationof atrioventricular conduction can be used to enhance effects of pacing. Pacing doesnot seem to induce lasting effects of a magnitude to influence hemodynamics or symptomsafter cessation of pacing. Key words: HOCM, pacing, LVOTobstruction, quality of life ISBN 91-628-2748-

Endocardial pacing compared to epicardial left ventricle pacing and right ventricle pacing: A single-center long-term experience in a pediatric population

Background and aims: Pediatric pacing is usually performed as epicardial pacing in small children in need of pacemaker therapy. Epicardial pacing compared with transvenous pacing for pediatric complete atrioventricular block (CAVB) has different strengths and weaknesses. The epicardial left ventricular wall position of the lead has been considered superior, in terms of contraction pattern, compared to a transvenous right ventricular stimulation. We aimed to compare QRS duration and cardiac function before and after the switch from epicardial to transvenous pacing in a pediatric population. Methods: Pediatric patients with congenital or acquired CAVB, who underwent a switch from epicardial-to transvenous pacing at our center from 2005 to 2021, were identified through the national ICD- and Pacemaker Registry. Data regarding clinical status, ECG, and echocardiography before and after the switch and at last follow-up were collected. Results: We included 15 children. The median age at the switch was 6.7 (4.4–11.7) years with a median weight of 21 (15–39) Kg. The median QRS duration with the transvenous systems was 136 (128–152) ms vs. a QRS duration during epicardial stimulation of 150 (144–170) ms with a median difference in QRS duration of 14 (6–20) ms. Children with a post-surgical AV block had a broader QRS duration, both with epicardial and endocardial stimulation. Before the switch, there was one patient with impaired left ventricular function (LVF) but with normal left ventricular end-diastolic diameters. After the switch, one patient developed symptomatic LV dysfunction with the recovery of LVF at the last follow-up after being implanted with a cardiac resynchronization therapy device. Conclusions: Our report of pediatric patients after switching from epicardial to transvenous pacing shows how transvenous pacing is not inferior to epicardial pacing in terms of QRS duration and no significant deterioration of cardiac function was detectable

Pacing for hypertrophic obstructive cardiomyopathy: an update and future directions

International audienceIn hypertrophic cardiomyopathy (HCM) patients with symptoms caused by left ventricular outflow tract obstruction (LVOTO), treatment options include negative inotropic drugs, myectomy, septal alcohol ablation and AV sequential pacing with or without an implantable cardioverter defibrillator (ICD). Pacing is rarely used in spite of its relative simplicity and promising results. In this review the current evidence of AV sequential pacing from observational, randomised studies and long and very long-term follow-up studies is given and put in the context of present guidelines recommendations. These studies indicate that AV sequential pacing improves symptoms and quality of life through decreases in LVOTO, systolic anterior movement and mitral regurgitation. Effects on morbidity and mortality are lacking. We describe the mechanisms of action, the prerequisites for successful pacing and provide practical advice on how to optimise therapy. Moreover, the role of the ICD for primary and secondary prevention is discussed with reference to the ESC HCM guidelines. In summary, AV sequential pacing for HOCM is underused in clinical practise despite evidence from two randomised controlled studies. This concept is currently the focus of two randomised studies: a planned randomised controlled study that will compare AV sequential pacing to TASH and an ongoing study that compares CRT to AAI pacing in HOCM patients. In this review we highlight the current evidence and the new interest for this therapy

Health-related quality of life in hypertrophic cardiomyopathy patients with implantable defibrillators

Background: Health-related quality of life (HRQL) in hypertrophic cardiomyopathy (HCM) patients with implantable cardioverter-defibrillators (ICDs) is largely unknown. The aim was to assess HRQL, including comparisons between groups, using the questionnaire SF-36, and compare it to a Swedish age-and sex-matched population. Methods and Results: Validated data on adult HCM patients with ICDs were used. The SF-36 response rate was 82.5 % and 245 patients (mean age 55.9 years, 70.2 % men) were analyzed using the Mann-Whitney U-test, t-test, Spearman correlation and effect size calculations. In all SF-36 domains the patients' score was lower (p-value of <0.0001) than norms except for bodily pain. The general health domain showed the highest effect size (0.77) and the impact was more pronounced in the SF-36 physical component summary score (0.62) than the mental component summary score (0.46). Older age was correlated with lower scores on the physical component and higher scores on the mental component. Atrial fibrillation and/or systolic heart failure were associated with worse physical health. HRQL was similar in primary vs secondary prevention cases. Inappropriate ICD shock was associated with worse mental health while appropriate therapy trended toward better mental health. Conclusion: HCM patients with ICDs suffer from poor HRQL regardless of age, sex, or primary vs secondary prevention indication. Atrial fibrillation and systolic heart failure are determinants of poor physical health. Inappropriate shocks, but not appropriate therapies, are associated with poorer mental health

Cardiovascular Imaging Applications in Clinical Management of Patients Treated with Cardiac Resynchronization Therapy

Cardiovascular imaging techniques, including echocardiography, nuclear cardiology, multi-slice computed tomography, and cardiac magnetic resonance, have wide applications in cardiac resynchronization therapy (CRT). Our aim was to provide an update of cardiovascular imaging applications before, during, and after implantation of a CRT device. Before CRT implantation, cardiovascular imaging techniques may integrate current clinical and electrocardiographic selection criteria in the identification of patients who may most likely benefit from CRT. Assessment of myocardial viability by ultrasound, nuclear cardiology, or cardiac magnetic resonance may guide optimal left ventricular (LV) lead positioning and help to predict LV function improvement by CRT. During implantation, echocardiographic techniques may guide in the identification of the best site of LV pacing. After CRT implantation, cardiovascular imaging plays an important role in the assessment of CRT response, which can be defined according to LV reverse remodeling, function and dyssynchrony indices. Furthermore, imaging techniques may be used for CRT programming optimization during follow-up, especially in patients who turn out to be non-responders. However, in the clinical settings, the use of proposed functional indices for different imaging techniques is still debated, due to their suboptimal feasibility and reproducibility. Moreover, identifying CRT responders before implantation and turning non-responders into responders at follow-up remain challenging issues

S taphylococcus aureus bacteraemia, cardiac implantable electronic device, and the risk of endocarditis : a retrospective population–based cohort study

Patients with cardiac implantable electronic device (CIED) and Staphylococcus aureus bacteraemia (SAB) are at risk of having infective endocarditis (IE). The objectives were to describe a Swedish population-based cohort of patients with CIED and SAB, to identify risk factors, and to construct a predictive score for IE. Patients over 18 years old in the Stockholm Region identified to have SAB in the Karolinska Laboratory database from January 2015 through December 2019 were matched to the Swedish Pacemaker and Implantable Cardioverter-Defibrillator ICD Registry to identify the study cohort. Data were collected from study of medical records. A cohort of 274 patients with CIED and SAB was identified and in 38 episodes (14%) IE were diagnosed, 19 with changes on the CIED, and 35 with changes on the left side of the heart. The risk factors predisposition for IE, community acquisition, embolization, time to positivity of blood cultures, and growth in blood culture after start of therapy in blood cultures were independently associated to IE. A score to identify patients with IE was constructed, the CTEPP score, and the chosen cut-off generated a sensitivity of 97%, specificity of 25%, and a negative predictive value of 98%. The score was externally validated in a population-based cohort of patients with CIED and SAB from another Swedish region. We found that 14% of patients with CIED and SAB had definite IE diagnosed. The CTEPP-score can be used to predict the risk of IE and, when negative, the risk is negligible