Implementation of ICD guidelines is difficult

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Implementation of ICD guidelines is difficult

Post by freckles1880 » June 29th, 2011, 8:37 am ... _Heartwire

Implementation of ICD guidelines is difficult in European countries facing budget crunch

JUNE 28, 2011 | Reed Miller
Madrid, Spain - As financial pressures on national healthcare budgets mount, more European physicians will take advice from cost-effectiveness assessments like those from the UK National Institute for Health and Clinical Excellence (NICE) instead of the professional practice guidelines, according to Dr Josep Brugada Terradellas (University of Barcelona, Spain).
"I'm absolutely convinced that we'll have to move to NICE-like guidelines," Terradellas told an audience here at the EUROPACE 2011 conference. "It's not enough to just take the results of studies and use those to create the guidelines, because the guidelines are dependent on the types of studies that industry funds. Governments don't have the money to create their own studies, so we have to rely on the studies paid by industry—which of course have value—but are managed in a specific direction. We have to make sure we enter economic and budget and efficiency concepts.
"Our current guidelines are lacking this practical part in how to really implement them," he said. Each country has to make difficult decisions about how to spend limited health resources. As a hypothetical example, Terradellas said that a very well-designed trial might show conclusively that a new oncology agent that costs thousands of dollars extends life expectancy by three months, but it doesn't make sense to spend money on this instead of, for example, prevention of sudden cardiac death in the young.
Terradellas said that in the face of 10% across-the-board cuts to all hospital budgets this year in his home region of Catalonia, Spain, his hospital is already following NICE recommendations to decide which therapies it should offer and to whom. Guidelines that take into account only clinical-trial results are "good when there are no budget restrictions, but at the moment we have restrictions and we need clear documents to help us through this."
While difficult decisions are inevitable, Terradellas added that "it's up to us, as the leaders in the field, to make the necessary noise to make the politicians understand that sudden cardiac arrest is a nice way to die when you're 95, but sudden cardiac death at a younger age is a disaster . . . and we need the resources to prevent that."
The chair of the session, Dr Günter Breithardt (University Hospital of Münster, Germany), suggested that it may be impossible for professional societies to develop scientifically sound guidelines that also take into account the cost-effectiveness issues, and so each country may have to create its own version of NICE. "It's a question of what guidelines should be. Is it just assessment of science, or also a [value] appraisal? That can only be done on the national levels because every country is different," he said. "We cannot solve that problem as a [European professional] society. So maybe we just have to focus on the scientific issues and deal with the economics in another document."

ICD guidelines are followed more closely in countries that can afford to
"In Europe, you all understand the principle that we should facilitate equal access to therapy to everybody," Terradellas said. "These very simple words mean that every single patient requiring a proven therapy should get it. It's clear, but it's probably difficult to achieve. So we need scientific evidence to make sure that the therapies that we want to apply have strong scientific evidence," and there are plenty of studies that provide strong evidence that implantable cardioverter defibrillators (ICDs) reduce the death rate in patients at risk for sudden cardiac death. Despite their evidentiary support, data published in the European Heart Rhythm Association (EHRA) White Book show adherence to the ICD guidelines is inconsistent across Europe and very low in some countries, and there are wide variations in ICD implant rates within countries based on the local availability of electrophysiology labs and specialists, he said.
The EHRA's main motivation for creating the White Book was to identify some of these disparities of care so that the EHRA and the European Society of Cardiology (ESC) can help nations resolve some of these disparities, Terradellas said. "Even though we have precise guidelines . . . we are not able to provide reliable information that is accepted and implemented in every country."
The White Book cites ICD cost-effectiveness studies demonstrating that "although full implementation of this therapy according to the guidelines has potentially high costs and organizational implications for European healthcare systems, [cost/benefit] analysis indicates that such expenditure represents good value for money." Despite the cost-effectiveness of ICDs, a lack of resources appears to be hindering many physicians' ability to follow the ICD guidelines. The White Book data show large discrepancies in the per-capita expenditure on various interventions among relatively rich countries that cannot be explained by differences in the national reimbursement systems alone, but it also demonstrates a linear relationship between the number of ICDs implanted per capita and the percent of a country's gross domestic product spent on healthcare.
The same trend appears in the ratio of dual-chamber vs single-chamber ICDs implanted in each country. Implants of dual-chamber devices were nearly zero in relatively poor countries such as Macedonia and Georgia but represented over half of ICD implants in Sweden and Switzerland, for example.
The data also show a correlation between life expectancy and the number of ICDs implanted per capita, but this is probably because the countries that implant more ICDs are generally richer and therefore have better life expectancy for many reasons, Terradellas suggested.

Do we need so many different guidelines?
Commenting on Terradellas's presentation, Dr Karl-Heinz Kuck (Asklepios Klinik, Hamburg, Germany) suggested that some physicians are not following the guidelines because they are so inundated with different international, European, and national guidelines that they've given up trying to sort out the different advice. Kuck said that he wishes the ESC would more routinely work with the American College of Cardiology and American Heart Association on guidelines development so that there is only one set of international guidelines for a given topic.
He also recommended that individual European countries forgo creating their own guidelines and instead just translate the European guidelines or international guidelines into their own language and add comments where necessary to tailor the guideline to the country's unique reimbursement scheme. Terradellas agreed that doctors and patients are not well-served by having to sort through several competing documents, and he has urged the Spanish Society of Cardiology to participate in Europe-wide guidelines creation instead of making its own. "Everybody wants to have his or her name on a guideline. Maybe we should stop putting names on guidelines, and it should just be an anonymous group of people working on the guidelines," he said.
Last edited by freckles1880 on June 29th, 2011, 1:35 pm, edited 1 time in total.
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Re: Implementation of ICD guidelines is difficult

Post by Lianachan » June 29th, 2011, 3:24 pm

Thanks for posting the article. I have always found the NICE guidelines and their Scottish counterpart SIGN baffling to follow. The latter states:
"Patients surviving the following ventricular arrhythmias in the absence of acute ischaemia or treatable cause should be considered for ICD implantation:
cardiac arrest (VT or VF)
VT with syncope or haemodynamic compromise
VT without syncope if LVEF<0.35 (not NYHA IV)."

My VF was supposed to be due to blocked arteries and so I had a double bypass to fix them. This seems to fall into the 'treatable cause' category to me, but maybe not. Whenever I ask the cardiologists the question I never understand the answer.

Another worrying SIGN quote is this one:
"Cost effectiveness of ICDs
The evidence on the cost effectiveness of ICDs is weak.11 0,111 Both improved targeting of patients
at greatest risk of sudden cardiac death and fewer hospital admissions for maintenance and
replacement of devices are likely to be necessary before the cost effectiveness ratios for ICDs
relative to medical therapy approach conventional cost effectiveness thresholds."

I also read the following the other day which might be of interest to someone. It's by one of the UK's leading experts on ICDs Professor John Morgan at Southampton. He did a presentation on 'which patients with low LVEF should NOT be referred for an ICD?' ... =24&fp=131


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