SAFER

SAFER The Helios-wide quality management and outcomes research programme on atrial fibrillation catheter ablation  Quality management programmes in the electrophysiology sector Administrative data in medicine is not only a gold mine in outcomes research and process optimization but also the obligation to provide information about quality of care for patients and colleagues. It has never been that easy to compare centres, using claims data. In the USA, the Medicare Access and CHIP Reauthorization Act (MACRA) ‘Rules and Regulations’ document predefined outcomes directly connected to reimbursement. For instance, in electrophysiology, The Heart Rhythm Society has developed separate performance measures: ICD complication rate (PQRS # 348), cardiac tamponade and/or pericardiocentesis following atrial fibrillation (AF) ablation (PQRS #392), infection within 180 days of a cardiac implantable electronic device implantation, replacement, or revision (PQRS #393).1 In contrast, institutional measurement and reporting is not mandatory in interventional electrophysiology in Germany now. In the electrophysiology sector, the German Cardiac Society has, however, published volume, structural, technical, and organizational recommendations.2 For instance, it is recommended that at least 75 procedures should be performed per year to ensure a sufficient routine, even after an initial certification process. Furthermore, the existence of standard operating procedures for the most threatening complications is required. However, institutional measurement and reporting on safety outcomes in general is not mandatory and variations remain unpublished. Why is that? Although transparency is advocated, the intrinsic fear to be substandard is present. However, it is important to remember that patient safety and outcome is a much higher value than the desire for diversified interventional offers, no matter of costs. The need for performance transparency has been addressed many times before and in a very pinpoint manner by Drs Smith and Shannon (‘To Bring Consumers to the Table, Simplify the Review’) in JAMA Internal Medicine.3 In our opinion, the goal should be to implement feasible outcome and safety measures that are nationwide comparable and consistent using predefined claims data tracers. Atrial fibrillation catheter ablation safety outcomes The Helios group, a German-wide hospital network with more than 100 hospitals and outpatient clinics, represents one of the largest patient care networks in Europe. In this exceptional setting with about 30 Helios hospitals performing 3500–4000 AF ablations annually, we have been working on the implementation of a scalable quality management programme on AF catheter ablation using claims data. Using administrative data (according to Section 21 KHEntgG), we designed tracers to identify cases with AF catheter ablation to build ‘SAFER’, the Heliosatrial fibrillation ablation registry. To the best of our knowledge, SAFER represents the largest German administrative based AF ablation data set to date. In a second step, we went further with the development of tracers identifying acute complications such as death, stroke, or transient ischaemic attack, pericardial tamponade, and vascular access complications requiring interventions. Based on claims data, we are thus the first to have established quality measurement metrics that analyse and report acute complications requiring interventions. By using these data, we can: set an example for comparable and up-to-date recording of complication rates in AF catheter ablation, analyse and understand care pathways of AF patients undergoing catheter ablation and focus on predictive analytics and research on patient outcomes. SAFER—the Heliosatrial fibrillation ablation registry Giving rise to the claims data grounded research database SAFER, we have performed analysis of >21 000 procedures between 2010 and 2017. Results on overall complication rates were presented as a Late Breaking Registry at the Germany Cardiac Society meeting (7 April 2018) and an in-depth analysis of pericardial tamponade as a Late Breaking Registry at the EHRA meeting (20 March 2018). There, we showed that pericardial effusion occurred in 0.9% of all AF ablation cases, and more than 88% could be treated by pericardiocentesis. Occurrence of pericardial tamponade involved factors ascribed to the patient (age, gender, and comorbidities), the type of catheter ablation (radiofrequency), and the institution (low volume centres). As we are currently working on the Helios Data Warehouse to grow, additional linkage to medication, lab values, genetic, and imaging information will complete the set of AF ablation procedures and will draw a conclusive picture. This approach is scalable for other procedures such as other catheter ablations or left atrial appendage occluder implantation. Outcome standards in atrial fibrillation catheter ablation With the publication of centre-anonymized Helios complication rates, we would like to bring the transparency discussion back into the spotlight and to stimulate a debate on volume and outcome minimum standards necessary for safe patient care in AF catheter ablation, to begin with and other electrophysiological procedures, to follow. On one hand, it is worthy of discussion whether elective procedures such as AF catheter ablation should be performed by a nationwide network of providers instead of chosen centres of excellence. On the other hand, it is important to know that there are small centres with high quality of care and low-complication rates and high-volume centres with above-average complication rates. Especially, the high variance in complication rates across the various centres has thus been a major point of discussion. Remarkably, a quality management programme based on prespecified claims data tracers would therefore be a systematic analysis under the same prerequisites—transparency within one’s reach. We are convinced that the presented quality management programme might develop as a standard of quality in the future beyond the Helios group. Laura Ueberham, MD1,3, Ekkehard Schuler, MD2, Gerhard Hindricks, MD1,3, Ralf Kuhlen, MD2,3, Andreas Bollmann, MD, PhD1,3 1Department of Electrophysiology, Helios Heart Center Leipzig, Leipzig University, Germany; 2Helios Kliniken GmbH, Berlin, Germany; and 3Leipzig Heart Institute, Leipzig, Germany Laura Ueberham uelaura@web.de Conflict of interest: none declared. References References are available as supplementary material at European Heart Journal online. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Heart Journal Oxford University Press

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Oxford University Press
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.
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0195-668X
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1522-9645
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10.1093/eurheartj/ehy255
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Abstract

The Helios-wide quality management and outcomes research programme on atrial fibrillation catheter ablation  Quality management programmes in the electrophysiology sector Administrative data in medicine is not only a gold mine in outcomes research and process optimization but also the obligation to provide information about quality of care for patients and colleagues. It has never been that easy to compare centres, using claims data. In the USA, the Medicare Access and CHIP Reauthorization Act (MACRA) ‘Rules and Regulations’ document predefined outcomes directly connected to reimbursement. For instance, in electrophysiology, The Heart Rhythm Society has developed separate performance measures: ICD complication rate (PQRS # 348), cardiac tamponade and/or pericardiocentesis following atrial fibrillation (AF) ablation (PQRS #392), infection within 180 days of a cardiac implantable electronic device implantation, replacement, or revision (PQRS #393).1 In contrast, institutional measurement and reporting is not mandatory in interventional electrophysiology in Germany now. In the electrophysiology sector, the German Cardiac Society has, however, published volume, structural, technical, and organizational recommendations.2 For instance, it is recommended that at least 75 procedures should be performed per year to ensure a sufficient routine, even after an initial certification process. Furthermore, the existence of standard operating procedures for the most threatening complications is required. However, institutional measurement and reporting on safety outcomes in general is not mandatory and variations remain unpublished. Why is that? Although transparency is advocated, the intrinsic fear to be substandard is present. However, it is important to remember that patient safety and outcome is a much higher value than the desire for diversified interventional offers, no matter of costs. The need for performance transparency has been addressed many times before and in a very pinpoint manner by Drs Smith and Shannon (‘To Bring Consumers to the Table, Simplify the Review’) in JAMA Internal Medicine.3 In our opinion, the goal should be to implement feasible outcome and safety measures that are nationwide comparable and consistent using predefined claims data tracers. Atrial fibrillation catheter ablation safety outcomes The Helios group, a German-wide hospital network with more than 100 hospitals and outpatient clinics, represents one of the largest patient care networks in Europe. In this exceptional setting with about 30 Helios hospitals performing 3500–4000 AF ablations annually, we have been working on the implementation of a scalable quality management programme on AF catheter ablation using claims data. Using administrative data (according to Section 21 KHEntgG), we designed tracers to identify cases with AF catheter ablation to build ‘SAFER’, the Heliosatrial fibrillation ablation registry. To the best of our knowledge, SAFER represents the largest German administrative based AF ablation data set to date. In a second step, we went further with the development of tracers identifying acute complications such as death, stroke, or transient ischaemic attack, pericardial tamponade, and vascular access complications requiring interventions. Based on claims data, we are thus the first to have established quality measurement metrics that analyse and report acute complications requiring interventions. By using these data, we can: set an example for comparable and up-to-date recording of complication rates in AF catheter ablation, analyse and understand care pathways of AF patients undergoing catheter ablation and focus on predictive analytics and research on patient outcomes. SAFER—the Heliosatrial fibrillation ablation registry Giving rise to the claims data grounded research database SAFER, we have performed analysis of >21 000 procedures between 2010 and 2017. Results on overall complication rates were presented as a Late Breaking Registry at the Germany Cardiac Society meeting (7 April 2018) and an in-depth analysis of pericardial tamponade as a Late Breaking Registry at the EHRA meeting (20 March 2018). There, we showed that pericardial effusion occurred in 0.9% of all AF ablation cases, and more than 88% could be treated by pericardiocentesis. Occurrence of pericardial tamponade involved factors ascribed to the patient (age, gender, and comorbidities), the type of catheter ablation (radiofrequency), and the institution (low volume centres). As we are currently working on the Helios Data Warehouse to grow, additional linkage to medication, lab values, genetic, and imaging information will complete the set of AF ablation procedures and will draw a conclusive picture. This approach is scalable for other procedures such as other catheter ablations or left atrial appendage occluder implantation. Outcome standards in atrial fibrillation catheter ablation With the publication of centre-anonymized Helios complication rates, we would like to bring the transparency discussion back into the spotlight and to stimulate a debate on volume and outcome minimum standards necessary for safe patient care in AF catheter ablation, to begin with and other electrophysiological procedures, to follow. On one hand, it is worthy of discussion whether elective procedures such as AF catheter ablation should be performed by a nationwide network of providers instead of chosen centres of excellence. On the other hand, it is important to know that there are small centres with high quality of care and low-complication rates and high-volume centres with above-average complication rates. Especially, the high variance in complication rates across the various centres has thus been a major point of discussion. Remarkably, a quality management programme based on prespecified claims data tracers would therefore be a systematic analysis under the same prerequisites—transparency within one’s reach. We are convinced that the presented quality management programme might develop as a standard of quality in the future beyond the Helios group. Laura Ueberham, MD1,3, Ekkehard Schuler, MD2, Gerhard Hindricks, MD1,3, Ralf Kuhlen, MD2,3, Andreas Bollmann, MD, PhD1,3 1Department of Electrophysiology, Helios Heart Center Leipzig, Leipzig University, Germany; 2Helios Kliniken GmbH, Berlin, Germany; and 3Leipzig Heart Institute, Leipzig, Germany Laura Ueberham uelaura@web.de Conflict of interest: none declared. References References are available as supplementary material at European Heart Journal online. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

Journal

European Heart JournalOxford University Press

Published: Jun 7, 2018

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