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5. Assessment of ICD eligibility in non-ischaemic cardiomyopathy patients:a position statement by the Task Force of the Dutch Society of Cardiology

Author

van der Lingen, Anne Lotte C.J., Verstraelen, Tom E., van Erven, Lieselot, Meeder, Joan G., Theuns, Dominic A., Vernooy, Kevin, Wilde, Arthur A.M., Maass, Alexander H., Allaart, Cornelis P., van der Lingen, Anne Lotte C.J., Verstraelen, Tom E., van Erven, Lieselot, Meeder, Joan G., Theuns, Dominic A., Vernooy, Kevin, Wilde, Arthur A.M., Maass, Alexander H., and Allaart, Cornelis P.

Abstract

International guidelines recommend implantation of an implantable cardioverter-defibrillator (ICD) in non-ischaemic cardiomyopathy (NICM) patients with a left ventricular ejection fraction (LVEF) below 35% despite optimal medical therapy and a life expectancy of more than 1 year with good functional status. We propose refinement of these recommendations in patients with NICM, with careful consideration of additional risk parameters for both arrhythmic and non-arrhythmic death. These additional parameters include late gadolinium enhancement on cardiac magnetic resonance imaging and genetic testing for high-risk genetic variants to further assess arrhythmic risk, and age, comorbidities and sex for assessment of non-arrhythmic mortality risk. Moreover, several risk modifiers should be taken into account, such as concomitant arrhythmias that may affect LVEF (atrial fibrillation, premature ventricular beats) and resynchronisation therapy. Even though currently no valid cut-off values have been established, the proposed approach provides a more careful consideration of risks that may result in withholding ICD implantation in patients with low arrhythmic risk and substantial non-arrhythmic mortality risk.

Published
2024

8. NL-EVDR:Netherlands—ExtraVascular Device Registry

Author

Tjong, Fleur V.Y., Breeman, Karel T.N., Boersma, Lucas V.A., Yap, Sing Chien, van Erven, Lieselot, van der Stoel, Michelle D., van Dijk, Vincent F., Maass, Alexander H., Knops, Reinoud E., Tjong, Fleur V.Y., Breeman, Karel T.N., Boersma, Lucas V.A., Yap, Sing Chien, van Erven, Lieselot, van der Stoel, Michelle D., van Dijk, Vincent F., Maass, Alexander H., and Knops, Reinoud E.

Abstract

Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands—ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR’s device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection.

Published
2023

9. Prophylactic Use of Implantable Cardioverter-Defibrillators in the Prevention of Sudden Cardiac Death in Dialysis Patients: The Prospective, Randomized, Controlled ICD2 Trial

Author

Jukema, J. Wouter, Timal, Rohit J., Rotmans, Joris I., Hensen, Liselotte C. R., Buiten, Maurits S., de Bie, Mihaly K., Putter, Hein, Zwinderman, Aeilko H., van Erven, Lieselot, Krol-van Straaten, M. Jacqueline, Hommes, Nienke, Gabreëls, Bas, van Dorp, Wim, van Dam, Bastiaan, Herzog, Charles A., Schalij, Martin J., and Rabelink, Ton J.

Published
2019
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10. The development of a decision aid for shared decision making in the Dutch implantable cardioverter defibrillator patient population: A novel approach to patient education

Author

Yilmaz, Dilek, Egorova, Anastasia D., Schalij, Martin J., Spierenburg, Han A. M., Verbunt, Robert A. M., and van Erven, Lieselot

Subjects
decision aid (DA), implantable cardioverter-defibrillator, shared decision making, cardiac geriatrics, Cardiology and Cardiovascular Medicine, decision making
Abstract

BackgroundCounseling of Implantable Cardioverter-defibrillator (ICD) patients with regard to individual risks and benefits is challenging. An evidence-based decision aid tailored to the needs of Dutch ICD patients is not yet available. The objective of this pilot project was to structurally evaluate the current clinical practice in The Netherlands and the ICD patient experience, in order to develop an online decision aid to facilitate shared decision making in ICD procedures.MethodsBetween June 2016 and December 2017, a Dutch web-based decision aid was developed according to the Patient Decision Aid Standards (IPDAS) using the RAND-UCLA/multi-stepped Delphi model. Development process consisted of 5 stages in which the Dutch clinical practice was reviewed (stage 1), patients’ needs and their history of decision making was structurally assessed (stages 2A and B) and a modified Delphi consensus process was performed with an expert panel consisting of representatives from different medical fields (stage 3). Results from stages 1–3 were used to design and structure the content of an online-based decision aid (stage 4) which was finally evaluated in a usability testing by patients in stage 5.Results and conclusionThis study describes the evidence-based approach to the development of the Dutch ICD decision aid. In our population, levels of shared decision-making experience were low. The ICD decision aid was structurally developed for the Dutch ICD patient population. Our upcoming multicenter stepped wedge clustered randomized trial will further evaluate the ICD decision aid in clinical practice.

Published
2022

14. Development of Central Venous Stenosis Upon ICD Implantation in Dialysis Patients: A Non-Negligible Issue

Author

J Timal, Rohit, primary, Karalis, Ioannis, additional, M Montero Cabezas, Jose, additional, I Rotmans, Joris, additional, C R Hensen, Liselotte, additional, S. Buiten, Maurits, additional, K de Bie, Mihaly, additional, van Erven, Lieselot, additional, Putter, Hein, additional, J. Schalij, Martin, additional, J Rabelink, Ton, additional, and Jukema, J Wouter, additional

Published
2022
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16. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring

Author

Heidbuchel, Hein, Hindricks, Gerd, Broadhurst, Paul, Van Erven, Lieselot, Fernandez-Lozano, Ignacio, Rivero-Ayerza, Maximo, Malinowski, Klaus, Marek, Andrea, Garrido, Rafael F. Romero, Löscher, Steffen, Beeton, Ian, Garcia, Enrique, Cross, Stephen, Vijgen, Johan, Koivisto, Ulla-Maija, Peinado, Rafael, Smala, Antje, and Annemans, Lieven

Published
2015
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17. Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death

Author

Verstraelen, Tom E, Van Barreveld, Marit, Van Dessel, Pascal H F M, Boersma, Lucas V A, Delnoy, Peter-paul P H M, Tuinenburg, Anton E, Theuns, Dominic A M J, Van Der Voort, Pepijn H, Kimman, Gerardus P, Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P, Strikwerda, Sipke, Scholten, Marcoen F, Meine, Mathias, Abels, René, Maass, Alexander H, Firouzi, Mehran, Widdershoven, Jos W M G, Elders, Jan, Van Gent, Marco W F, Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W, Tukkie, Raymond, Van Erven, Lieselot, Spierenburg, Han A M, Brouwer, Marc A, Bartels, Gerard L, Bijsterveld, Nick R, Borger Van Der Burg, Alida E, Vet, Mattheus W, Derksen, Richard, Knops, Reinoud E, Bracke, Frank A L E, Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G W, Zwinderman, Aeilko H, Wilde, Arthur A M, Verstraelen, Tom E, Van Barreveld, Marit, Van Dessel, Pascal H F M, Boersma, Lucas V A, Delnoy, Peter-paul P H M, Tuinenburg, Anton E, Theuns, Dominic A M J, Van Der Voort, Pepijn H, Kimman, Gerardus P, Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P, Strikwerda, Sipke, Scholten, Marcoen F, Meine, Mathias, Abels, René, Maass, Alexander H, Firouzi, Mehran, Widdershoven, Jos W M G, Elders, Jan, Van Gent, Marco W F, Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W, Tukkie, Raymond, Van Erven, Lieselot, Spierenburg, Han A M, Brouwer, Marc A, Bartels, Gerard L, Bijsterveld, Nick R, Borger Van Der Burg, Alida E, Vet, Mattheus W, Derksen, Richard, Knops, Reinoud E, Bracke, Frank A L E, Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G W, Zwinderman, Aeilko H, and Wilde, Arthur A M

Abstract

Aims This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. Methods and results We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1–2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0–3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. Conclusion Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Published
2021

18. Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death

Author

Verstraelen, Tom E., van Barreveld, Marit, van Dessel, Pascal H.F.M., Boersma, Lucas V.A., Delnoy, Peter Paul P.H.M., Tuinenburg, Anton E., Theuns, Dominic A.M.J., van der Voort, Pepijn H., Kimman, Gerardus P., Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P., Strikwerda, Sipke, Scholten, Marcoen F., Meine, Mathias, Abels, René, Maass, Alexander H., Firouzi, Mehran, Widdershoven, Jos W.M.G., Elders, Jan, van Gent, Marco W.F., Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W., Tukkie, Raymond, van Erven, Lieselot, Spierenburg, Han A.M., Brouwer, Marc A., Bartels, Gerard L., Bijsterveld, Nick R., Borger van der Burg, Alida E., Vet, Mattheus W., Derksen, Richard, Knops, Reinoud E., Bracke, Frank A.L.E., Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G.W., Zwinderman, Aeilko H., Wilde, Arthur A.M., Verstraelen, Tom E., van Barreveld, Marit, van Dessel, Pascal H.F.M., Boersma, Lucas V.A., Delnoy, Peter Paul P.H.M., Tuinenburg, Anton E., Theuns, Dominic A.M.J., van der Voort, Pepijn H., Kimman, Gerardus P., Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P., Strikwerda, Sipke, Scholten, Marcoen F., Meine, Mathias, Abels, René, Maass, Alexander H., Firouzi, Mehran, Widdershoven, Jos W.M.G., Elders, Jan, van Gent, Marco W.F., Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W., Tukkie, Raymond, van Erven, Lieselot, Spierenburg, Han A.M., Brouwer, Marc A., Bartels, Gerard L., Bijsterveld, Nick R., Borger van der Burg, Alida E., Vet, Mattheus W., Derksen, Richard, Knops, Reinoud E., Bracke, Frank A.L.E., Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G.W., Zwinderman, Aeilko H., and Wilde, Arthur A.M.

Abstract

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Published
2021

19. Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death

Author

Team Medisch, Circulatory Health, Verstraelen, Tom E, van Barreveld, Marit, van Dessel, Pascal H F M, Boersma, Lucas V A, Delnoy, Peter-Paul P H M, Tuinenburg, Anton E, Theuns, Dominic A M J, van der Voort, Pepijn H, Kimman, Gerardus P, Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P, Strikwerda, Sipke, Scholten, Marcoen F, Meine, Mathias, Abels, René, Maass, Alexander H, Firouzi, Mehran, Widdershoven, Jos W M G, Elders, Jan, van Gent, Marco W F, Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W, Tukkie, Raymond, van Erven, Lieselot, Spierenburg, Han A M, Brouwer, Marc A, Bartels, Gerard L, Bijsterveld, Nick R, Borger van der Burg, Alida E, Vet, Mattheus W, Derksen, Richard, Knops, Reinoud E, Bracke, Frank A L E, Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G W, Zwinderman, Aeilko H, Wilde, Arthur A M, Team Medisch, Circulatory Health, Verstraelen, Tom E, van Barreveld, Marit, van Dessel, Pascal H F M, Boersma, Lucas V A, Delnoy, Peter-Paul P H M, Tuinenburg, Anton E, Theuns, Dominic A M J, van der Voort, Pepijn H, Kimman, Gerardus P, Buskens, Erik, Hulleman, Michiel, Allaart, Cornelis P, Strikwerda, Sipke, Scholten, Marcoen F, Meine, Mathias, Abels, René, Maass, Alexander H, Firouzi, Mehran, Widdershoven, Jos W M G, Elders, Jan, van Gent, Marco W F, Khan, Muchtiar, Vernooy, Kevin, Grauss, Robert W, Tukkie, Raymond, van Erven, Lieselot, Spierenburg, Han A M, Brouwer, Marc A, Bartels, Gerard L, Bijsterveld, Nick R, Borger van der Burg, Alida E, Vet, Mattheus W, Derksen, Richard, Knops, Reinoud E, Bracke, Frank A L E, Harden, Markus, Sticherling, Christian, Willems, Rik, Friede, Tim, Zabel, Markus, Dijkgraaf, Marcel G W, Zwinderman, Aeilko H, and Wilde, Arthur A M

Published
2021

24. Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death

Author

Verstraelen, Tom E, primary, van Barreveld, Marit, additional, van Dessel, Pascal H F M, additional, Boersma, Lucas V A, additional, Delnoy, Peter-Paul P H M, additional, Tuinenburg, Anton E, additional, Theuns, Dominic A M J, additional, van der Voort, Pepijn H, additional, Kimman, Gerardus P, additional, Buskens, Erik, additional, Hulleman, Michiel, additional, Allaart, Cornelis P, additional, Strikwerda, Sipke, additional, Scholten, Marcoen F, additional, Meine, Mathias, additional, Abels, René, additional, Maass, Alexander H, additional, Firouzi, Mehran, additional, Widdershoven, Jos W M G, additional, Elders, Jan, additional, van Gent, Marco W F, additional, Khan, Muchtiar, additional, Vernooy, Kevin, additional, Grauss, Robert W, additional, Tukkie, Raymond, additional, van Erven, Lieselot, additional, Spierenburg, Han A M, additional, Brouwer, Marc A, additional, Bartels, Gerard L, additional, Bijsterveld, Nick R, additional, Borger van der Burg, Alida E, additional, Vet, Mattheus W, additional, Derksen, Richard, additional, Knops, Reinoud E, additional, Bracke, Frank A L E, additional, Harden, Markus, additional, Sticherling, Christian, additional, Willems, Rik, additional, Friede, Tim, additional, Zabel, Markus, additional, Dijkgraaf, Marcel G W, additional, Zwinderman, Aeilko H, additional, and Wilde, Arthur A M, additional

Published
2021
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47. Management of radiation oncology patients with a pacemaker or ICD: A new comprehensive practical guideline in The Netherlands

Author

Hurkmans Coen W, Knegjens Joost L, Oei Bing S, Maas Ad JJ, Uiterwaal GJ, van der Borden Arnoud J, Ploegmakers Marleen MJ, and van Erven Lieselot

Subjects
Pacemaker, Implantable cardioverter defibrillator, Guideline, CIED, Risk management, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Current clinical guidelines for the management of radiotherapy patients having either a pacemaker or implantable cardioverter defibrillator (both CIEDs: Cardiac Implantable Electronic Devices) do not cover modern radiotherapy techniques and do not take the patient’s perspective into account. Available data on the frequency and cause of CIED failure during radiation therapy are limited and do not converge. The Dutch Society of Radiotherapy and Oncology (NVRO) initiated a multidisciplinary task group consisting of clinical physicists, cardiologists, radiation oncologists, pacemaker and ICD technologists to develop evidence based consensus guidelines for the management of CIED patients. CIED patients receiving radiotherapy should be categorised based on the chance of device failure and the clinical consequences in case of failure. Although there is no clear cut-off point nor a clear linear relationship, in general, chances of device failure increase with increasing doses. Clinical consequences of device failures like loss of pacing, carry the most risks in pacing dependent patients. Cumulative dose and pacing dependency have been combined to categorise patients into low, medium and high risk groups. Patients receiving a dose of less than 2 Gy to their CIED are categorised as low risk, unless pacing dependent since then they are medium risk. Between 2 and 10 Gy, all patients are categorised as medium risk, while above 10 Gy every patient is categorised as high risk. Measures to secure patient safety are described for each category. This guideline for the management of CIED patients receiving radiotherapy takes into account modern radiotherapy techniques, CIED technology, the patients’ perspective and the practical aspects necessary for the safe management of these patients. The guideline is implemented in The Netherlands in 2012 and is expected to find clinical acceptance outside The Netherlands as well.

Published
2012
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48. Evaluation of the Impact of a Chronic Total Coronary Occlusion on Ventricular Arrhythmias and Long‐Term Mortality in Patients With Ischemic Cardiomyopathy and an Implantable Cardioverter‐Defibrillator (the eCTOpy‐in‐ICD Study)

Author

van Dongen, Ivo M., primary, Yilmaz, Dilek, additional, Elias, Joëlle, additional, Claessen, Bimmer E. P. M., additional, Delewi, Ronak, additional, Knops, Reinoud E., additional, Wilde, Arthur A. M., additional, van Erven, Lieselot, additional, Schalij, Martin J., additional, and Henriques, José P. S., additional

Published
2018
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50. Nationwide Longitudinal Follow-Up of Riata Leads Under Advisory at 3 Annual Screenings: Report From the Netherlands Heart Rhythm Association Device Advisory Committee

Author

Cardiologie, Circulatory Health, Team Medisch, Theuns, Dominic A M J, van Erven, Lieselot, Kimman, Geert P., de Cock, Carel C., Elvan, Arif, Alings, Marco A., van Opstal, Jurren, Meine, Mathias, Cardiologie, Circulatory Health, Team Medisch, Theuns, Dominic A M J, van Erven, Lieselot, Kimman, Geert P., de Cock, Carel C., Elvan, Arif, Alings, Marco A., van Opstal, Jurren, and Meine, Mathias

Published
2017

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