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

Abstract

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years1,2 as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection,3 lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries.4 There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 20095 and 2017,6 and by EHRA in 2012.7 Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours. This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction. In order to clarify the indications for lead extraction the following definitions are proposed (see Table 1). CIED-related infection types CIED, cardiac implantable electronic device. This was the most frequent indication for TLE in the ELECTRa registry amounting to 52.8% (of which approximately two-thirds were local infections).4 Several entities exist, which should be specified. This is defined as an infection limited to the generator pocket or along the lead course. It is clinically associated with local signs of inflammation, including erythema, warmth, fluctuance, wound dehiscence, tenderness, or purulent drainage, with negative blood cultures.8–10 This entity should be differentiated from superficial incisional Infection, which involves only skin and subcutaneous tissue without communication with the pocket (and may not require lead extraction). This is a chronic process whereby the device and/or lead(s) are exposed through the skin, with or without local signs of infection (the device should however be considered infected, whatever the mechanism for erosion). Very often the erosion is preceded by the adherence of the skin on the device with a concomitant browning and thinning of the skin. Erosion is usually indicative of infection. Blood cultures are negative, and some of these patients are asymptomatic, while others complain of local pain. In presence of positive blood cultures with or without systemic infection symptoms and signs. Local signs of pocket infection and positive blood cultures and lead or valvular vegetation(s). The 2015 European Society of Cardiology (ESC) modified Duke Criteria8 have been used to define endocarditis. It should be noted that these criteria are used to define valvular endocarditis. For CIED-related endocarditis, additional criteria might be considered, such as positive cultures of the extracted lead in case of negative blood cultures, presence of lead vegetations, and abnormal metabolic activity around the CIED generator and/or leads detected by 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) or radiolabelled leucocytes single-photon-emission computed tomography/CT. Local signs of pocket infection and positive blood cultures, without lead or valvular vegetation(s). Bacteraemia with or without lead or valvular vegetation(s), and without local signs of pocket infection. Bacteraemia without an obvious source other than the CIED. After extraction, disappearance of bacteraemia is expected. In case of lead dysfunction, there is the option of abandoning the lead or extracting it (e.g. to reduce intravascular lead burden or regain access in the presence of venous occlusion). Lead dysfunction was the second most frequent reason for lead extraction in the ELECTRa registry, amounting to 38.1% of cases.4 Causes for lead dysfunction may be lead fracture or insulation failure resulting in issues with lead impedance, sensing or capture