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FDA approves new miniaturized ICDs and cardiac resynchronization therapy defibrillators

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2016-01-19 19:54:03
The FDA has approved 4 new heart pacing devices, the Dynagen Mini and Inogen Mini ICDs and the Dynagen X4 and Inogen X4 cardiac resynchronization therapy defibrillators (CRT-Ds). The Mini ICDs are up to 24% thinner and 20% smaller by volume than other ICDs. 

Indications for ICD implantation can be divided into 2 broad categories: secondary prophylaxis against sudden cardiac death and primary prophylaxis. For secondary prophylaxis, ICD placement is indicated as initial therapy in survivors of cardiac arrest due to VF or hemodynamically unstable VT. Published guidelines exclude cases in which there are “completely reversible causes,”[2] although this exclusion is somewhat controversial.

Currently, indications for primary prophylaxis account for most of ICD implants, even though the evidence for such implants is often less well established. Class I indications (ie, the benefit greatly outweighs the risk, and the treatment should be administered) are as follows:

  • Structural heart disease, sustained VT
  • Syncope of undetermined origin, inducible VT or VF at electrophysiologic study (EPS)
  • Left ventricular ejection fraction (LVEF) < 35% due to prior MI, at least 40 days post-MI, NYHA class II or III
  • LVEF ≤35%, NYHA class II or III
  • LVEF ≤30% due to prior MI, at least 40 days post-MI
  • LVEF < 40% due to prior MI, inducible VT or VF at EPS

Class IIa indications (ie, the benefit outweighs the risk and it is reasonable to administer the treatment) are as follows:

  • Unexplained syncope, significant LV dysfunction, nonischemic cardiomyopathy
  • Sustained VT, normal or near-normal ventricular function
  • Hypertrophic cardiomyopathy with 1 or more major risk factors
  • Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) with 1 or more risk factors for sudden cardiac death (SCD)
  • Long QT syndrome, syncope or VT while receiving beta-blockers
  • Nonhospitalized patients awaiting heart transplant
  • Brugada syndrome, syncope or VT
  • Catecholaminergic polymorphic VT, syncope or VT while receiving beta-blockers
  • Cardiac sarcoidosis, giant cell myocarditis, or Chagas disease

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