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When to Use ICDs in Patients Whom the Guidelines Don't Capture

Guideline Watch |
August 4, 2014

When to Use ICDs in Patients Whom the Guidelines Don't Capture

  1. Mark S. Link, MD

Many patients who are not included or well represented in clinical trials of implantable cardioverter-defibrillators may benefit from the devices.

  1. Mark S. Link, MD

Sponsoring Organizations: American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and Heart Rhythm Society (HRS)

Target Population: Cardiologists and cardiac electrophysiologists

Background and Objective

The ACCF, AHA, and HRS have issued a consensus statement about the appropriateness of implantable cardioverter-defibrillator (ICD) implantation for patients whom clinical trials do not include or represent and who, therefore, are not technically covered by formal practice guidelines. The document divides these patients into four categories, lettered A through D in the “Key Points” section below.

Key Points

Patients with Abnormal Troponin Unrelated to a Myocardial Infarction (MI)

Current guidelines recommend that an ICD should not be implanted until at least 40 days after an MI, given data showing that a patient's left ventricular ejection fraction (LVEF) may improve after an acute ischemic insult and findings from two trials that evaluated early ICD implantation after MI (DINAMIT and IRIS). However, small troponin leaks sometimes occur in the context of demand ischemia (e.g., tachyarrhythmia, congestive heart failure, pulmonary embolism) or other conditions (renal failure, myocarditis) that are thought to be unrelated to MI. The consensus statement recommends ICD implantation for these patients if they would otherwise be candidates for an ICD on the basis of primary- or secondary-prevention criteria.

Patients Who Are Still Within 40 Days After an MI

The consensus document confirms that, as a general rule, ICDs are not recommended within 40 days after an MI, including for patients with a preexisting low LVEF who would have benefited from primary prevention. However, it specifies several exceptions — i.e., subgroups who may benefit from an ICD despite being within 40 days of an MI:

  • Patients with an indication for permanent pacemaker (PPM) implantation and an LVEF that is unlikely to improve

  • Patients with a hemodynamically significant ventricular arrhythmia more than 48 hours after MI

  • Patients who, more than 48 hours after MI, present with syncope that is likely to be attributable to a ventricular tachyarrhythmia

  • Patients with a previously implanted ICD that requires elective replacement for battery depletion

  • Patients who have significant LV dysfunction and are candidates for heart transplantation or have a left ventricular assist device (LVAD)

Patients Who Are Within 90 Days After Revascularization

ICD trials have largely excluded patients who are within 90 days after revascularization because of the postprocedure potential for the LVEF to improve. The consensus document specifies several subgroups that may benefit from an ICD despite being within 90 days after revascularization:

  • Patients who have known LV dysfunction and have previously met LVEF criteria for a primary-prevention ICD

  • Patients who meet criteria for a secondary-prevention ICD

  • Patients who have an indication for PPM implantation but meet LVEF criteria for an ICD

  • Patients with a previously implanted ICD that requires elective replacement for battery depletion

  • Patients who are candidates for heart transplantation or have an LVAD

Patients Who Are Within 9 Months of an Initial Nonischemic Cardiomyopathy (NICM) Diagnosis

Many ICD trials have excluded patients with recently diagnosed NICM because of the potential for medical therapy to improve the LVEF. The consensus document specifies several subgroups that may benefit from an ICD despite being within 9 months after an initial NICM diagnosis:

  • Patients who have significant LV dysfunction and heart-failure symptoms more than 3 months after diagnosis, if recovery of LVEF is not expected.

  • Patients who meet criteria for a primary-prevention ICD and who also have an indication for a PPM

  • Patients who have sustained or hemodynamically significant ventricular tachyarrhythmias

  • Patients who present with syncope that is likely to be attributable to a ventricular tachyarrhythmia

  • Patients who are candidates for heart transplantation or have an LVAD

Comment

Notably, the consensus document offers nuanced characterizations of the patient subgroups in each of the four categories listed above. For example, sometimes an ICD is “recommended” for the subgroup, and in other cases the authors say that an ICD “may be useful.” Physicians and insurers who need to understand which patients who are not mentioned in formal guidelines may benefit from an ICD will find value in the nuances of this document, which they should consult for specifics. The exceptions to the guidelines are generally reasonable and address common scenarios in clinical cardiology and cardiac electrophysiology.

  • Disclosures for Mark S. Link, MD at time of publication Grant / Research support Unequal Technologies Editorial boards UpToDate

Citation(s):

Reader Comments (1)

RONALD HIRSCH Physician, Internal Medicine

These new guidelines put doctors and hospitals in a bad place. Medicare has strict criteria to determine when they pay for an ICD (with no room for clinical judgment) and these new criteria are not on that list. So does a hospital go ahead and let the doctor put in a $30,000 device and not get paid for it or ask the patient to pay for it if they want it?

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