Critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study”

Johannes Sperzel,1 Ingo Staudacher,2 Olaf Goeing,3 Martin Stockburger,4 Thorsten Meyer,5 Ana Sofia Oliveira Gonçalves,6 Hanna Sydow,6 Tonio Schoenfelder,6 Volker Eric Amelung6 1Department of Cardiology, Hospital Kerckhoff Klinik GmbH, Bad Nauheim, Germany; 2Department of Cardiology, Medical University Hospital Heidelberg, Heidelberg, Germany; 3Department of Cardiology, Sana-Hospital Lichtenberg, Berlin, Germany; 4Medical Department I, Havelland Kliniken GmbH, Nauen, Germany; 5Department of Public Health, Universität Bielefeld, Bielefeld, Germany; 6Institute for Applied Health Services Research, inav – privates Institut für angewandte Versorgungsforschung GmbH, Berlin, GermanyWe read with great interest the article “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study” by Ettinger et al. The authors conclude that wearable cardioverter defibrillators (WCDs) seem to be fairly safe in the short-to-medium term, but the quality of the available evidence is low. They also state that – according to their study inclusion criteria – they were not able to identify studies to assess the clinical effectiveness of the WCD. Given the importance of WCD for its target population and considering our clinical expertise, we see a particular need to clarify some points of this article.Author's ReplySabine Ettinger,1 Michal Stanak,1 Piotr Szymański,2 Claudia Wild,1 Romana Tandara Haček,3 Darija Erčević,3 Renata Grenković,3 Mirjana Huić31Ludwig Boltzmann Institute for Health Technology Assessment, Vienna, Austria; 2Institute of Cardiology, Warsaw, Poland; 3Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaWe read the letter to the editor with regard to our published paper on “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study” and gladly take the opportunity to appropriately address and clarify the issues that were raised. View the original paper by Ettinger and colleagues.&nbsp

Comments on the authors’ reply to the critical appraisal concerning “Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study”

Johannes Sperzel,1 Ingo Staudacher,2 Olaf Goeing,3 Martin Stockburger,4 Thorsten Meyer,5 Ana Sofia Oliveira Gonçalves,6 Hanna Sydow,6 Tonio Schoenfelder,6 Volker Amelung6 1Department of Cardiology, Hospital Kerckhoff Klinik GmbH, Bad Nauheim, Germany; 2Department of Cardiology, Medical University Hospital Heidelberg, Heidelberg, Germany; 3Department of Cardiology, Sana-Hospital Lichtenberg, Berlin, Germany; 4Medical Department I, Havelland Kliniken GmbH, Nauen, Germany; 5Department of Public Health, Universität Bielefeld, Bielefeld, Germany; 6inav – privates Institut für angewandte Versorgungsforschung GmbH, Berlin, GermanySince the authors’ reply to our critical appraisal did not properly address the points we raised, we still see need for further clarification. The wearable cardioverter defibrillator (WCD) is not an adequate substitute for an implantable cardioverter defibrillator (ICD). The authors state that both can be compared immediately post-myocardial infarction (MI). According to the current guidelines, primary prevention of sudden cardiac death with the ICD within 40 days after MI is generally not indicated.1 Therefore, we disagree with the authors’ proposal of conducting such a trial. In this context, the authors mentioned the VEST trial, which compares a WCD population and one receiving medical treatment. There is explicitly no comparison to an ICD population.View the original paper by Sperzel and colleagues

EURObservational Research Programme: Regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot)

AimsThe ESC-HF Pilot survey was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). The pilot phase was also specifically aimed at validating structure, performance, and quality of the data set for continuing the survey into a permanent Registry.MethodsThe ESC-HF Pilot study is a prospective, multicentre, observational survey conducted in 136 Cardiology Centres in 12 European countries selected to represent the different health systems across Europe. All outpatients with HF and patients admitted for acute HF on 1 day per week for eight consecutive months were included. From October 2009 to May 2010, 5118 patients were included: 1892 (37%) admitted for acute HF and 3226 (63%) patients with chronic HF. The all-cause mortality rate at 1 year was 17.4% in acute HF and 7.2% in chronic stable HF. One-year hospitalization rates were 43.9% and 31.9%, respectively, in hospitalized acute and chronic HF patients. Major regional differences in 1-year mortality were observed that could be explained by differences in characteristics and treatment of the patients.ConclusionThe ESC-HF Pilot survey confirmed that acute HF is still associated with a very poor medium-term prognosis, while the widespread adoption of evidence-based treatments in patients with chronic HF seems to have improved their outcome profile. Differences across countries may be due to different local medical practice as well to differences in healthcare systems. This pilot study also offered the opportunity to refine the organizational structure for a long-term extended European network. © 2013 The Author

EURObservational Research Programme: Regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot)

AimsThe ESC-HF Pilot survey was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). The pilot phase was also specifically aimed at validating structure, performance, and quality of the data set for continuing the survey into a permanent Registry.MethodsThe ESC-HF Pilot study is a prospective, multicentre, observational survey conducted in 136 Cardiology Centres in 12 European countries selected to represent the different health systems across Europe. All outpatients with HF and patients admitted for acute HF on 1 day per week for eight consecutive months were included. From October 2009 to May 2010, 5118 patients were included: 1892 (37%) admitted for acute HF and 3226 (63%) patients with chronic HF. The all-cause mortality rate at 1 year was 17.4% in acute HF and 7.2% in chronic stable HF. One-year hospitalization rates were 43.9% and 31.9%, respectively, in hospitalized acute and chronic HF patients. Major regional differences in 1-year mortality were observed that could be explained by differences in characteristics and treatment of the patients.ConclusionThe ESC-HF Pilot survey confirmed that acute HF is still associated with a very poor medium-term prognosis, while the widespread adoption of evidence-based treatments in patients with chronic HF seems to have improved their outcome profile. Differences across countries may be due to different local medical practice as well to differences in healthcare systems. This pilot study also offered the opportunity to refine the organizational structure for a long-term extended European network. © 2013 The Author

EURObservational Research Programme: Regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot)

AimsThe ESC-HF Pilot survey was aimed to describe clinical epidemiology and 1-year outcomes of outpatients and inpatients with heart failure (HF). The pilot phase was also specifically aimed at validating structure, performance, and quality of the data set for continuing the survey into a permanent Registry.MethodsThe ESC-HF Pilot study is a prospective, multicentre, observational survey conducted in 136 Cardiology Centres in 12 European countries selected to represent the different health systems across Europe. All outpatients with HF and patients admitted for acute HF on 1 day per week for eight consecutive months were included. From October 2009 to May 2010, 5118 patients were included: 1892 (37%) admitted for acute HF and 3226 (63%) patients with chronic HF. The all-cause mortality rate at 1 year was 17.4% in acute HF and 7.2% in chronic stable HF. One-year hospitalization rates were 43.9% and 31.9%, respectively, in hospitalized acute and chronic HF patients. Major regional differences in 1-year mortality were observed that could be explained by differences in characteristics and treatment of the patients.ConclusionThe ESC-HF Pilot survey confirmed that acute HF is still associated with a very poor medium-term prognosis, while the widespread adoption of evidence-based treatments in patients with chronic HF seems to have improved their outcome profile. Differences across countries may be due to different local medical practice as well to differences in healthcare systems. This pilot study also offered the opportunity to refine the organizational structure for a long-term extended European network

Ezetimibe added to statin therapy after acute coronary syndromes

BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known. METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization ( 6530 days after randomization), or nonfatal stroke. The median follow-up was 6 years. RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P = 0.016). Rates of pre-specified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups. CONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit