Results of Expert Meetings
Preventing tomorrow's sudden cardiac death today: Part I: Current data on risk stratification for sudden cardiac death

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Accurate and timely prediction of sudden cardiac death (SCD) is a necessary prerequisite for effective prevention and therapy. Although the largest number of SCD events occurs in patients without overt heart disease, there are currently no tests that are of proven predictive value in this population. Efforts in risk stratification for SCD have focused primarily on predicting SCD in patients with known structural heart disease. Despite the ubiquity of tests that have been purported to predict SCD vulnerability in such patients, there is little consensus on which test, in addition to the left ventricular ejection fraction, should be used to determine which patients will benefit from an implantable cardioverter defibrillator.

On July 20 and 21, 2006, a group of experts representing clinical cardiology, cardiac electrophysiology, biostatistics, economics, and health policy were joined by representatives of the US Food and Drug administration, Centers for Medicare Services, Agency for Health Research and Quality, the Heart Rhythm Society, and the device and pharmaceutical industry for a round table meeting to review current data on strategies of risk stratification for SCD, to explore methods to translate these strategies into practice and policy, and to identify areas that need to be addressed by future research studies. The meeting was organized by the Duke Center for the Prevention of SCD at the Duke Clinical Research Institute and was funded by industry participants. This article summarizes the presentations and discussions that occurred at that meeting.

Section snippets

Assessment of SCD risk: general considerations

One important challenge in studying SCD and its prevention lies in the accurate identification of the event. The definitions of SCD that are most commonly used are necessarily operational and take account of the limited and often circumstantial nature of the evidence available for the task. In addition, SCD is not a homogeneous pathophysiologic entity, but it is the final phenotypic manifestation of a number of unrelated disorders. These 2 factors alone introduce significant difficulties into

Assessment of SCD risk: specific tests and strategies

Several risk assessment strategies for SCD were discussed at the meeting. Data on these strategies are detailed below.

Role of the National ICD Registry

When the Centers for Medicare Services (CMS) officials issued the National Coverage Determination on January 27, 2005, to expand coverage for ICD implantation for the primary prevention of SCD, they mandated that data on all such implants in Medicare beneficiaries be entered in a National ICD Registry. The main goal of CMS for the Registry was to determine whether Medicare beneficiaries who meet the clinical criteria identified in the agency's National Coverage Determination derive benefit from

Future studies

Future efforts should focus on examining existing and novel markers in patients with ischemic and nonischemic heart disease to identify those who are more likely to benefit from an ICD. Markers that deserve attention include TWA, measures of cardiac autonomic modulation, QT variability, scar characteristics via MRI, and genetic and serum markers. Some of these markers are being examined in the National Institutes of Health–funded MADIT-II risk stratification substudy. This study will enroll 792

Conclusions

Although many tests of SCD vulnerability have been examined in patients with ischemic heart disease, current data do not support the consistent use of any test, other than the LVEF, to risk-stratify these patients. Efforts should focus on examining existing and novel markers in patients meeting the inclusion criteria of published clinical trials of ICD therapy to identify those who will benefit from an ICD. In that regard, risk modeling will likely be needed. Whether predictors differ

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    This conference was funded by AstraZeneca, Bayer, Boston Scientific, Cambridge Heart Inc, Medtronic, Reliant Pharmaceuticals, St Jude Medical.

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