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

2018 EHRA expert consensus statement on lead extraction: Recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: Endorsed by APHRS/HRS/LAHRS

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The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead. The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited. We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance. Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p = 0.006). There were no major procedural complications or deaths. Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration