Introduction

Dehydrated alcohol is a sclerosing agent.

Uses for Dehydrated Alcohol

Dehydrated alcohol has the following uses:

Dehydrated alcohol is an sclerosing agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.

Dehydrated Alcohol Dosage and Administration

General

Dehydrated alcohol is available in the following dosage form(s) and strength(s):

• Injection: 1 mL or 5 mL of ethyl alcohol ≥99% by volume as a clear, colorless liquid in a single-dose glass ampul.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient.

• In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL.

Contraindications

• None.

Warnings/Precautions

Heart Block

Transient Heart Block: Transient heart block is common at the time of dehydrated alcohol injection into a septal artery. Prior to the injection, a temporary pacing wire is routinely inserted into the apex of the right ventricle, usually via the femoral vein, to treat transient heart block. The pacing lead can be removed if no episode of high-degree atrioventricular block occurs, usually after several hours of observation following percutaneous transluminal septal myocardial ablation.

Persistent Heart Block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker following percutaneous transluminal septal myocardial ablation. Risk factors for permanent pacemaker dependency after septal ablation include a baseline PQ interval >160 msec, baseline minimum heart rate <50 bpm, baseline left ventricular outflow gradient >70 mmHg, maximum QRS during the first 48 hours >155 msec, 3rd degree atrioventricular block occurring during the procedure, and no clinical recovery between 12–48 hours after the procedure.

Myocardial Infarction

Injection of dehydrated alcohol is intended to create a controlled myocardial infarction for therapeutic purposes. However, excessive myocardial necrosis and subsequent heart failure have been reported. Factors increasing the risk of excessive tissue necrosis include higher volume of alcohol used and a higher number of septal branches injected to reduce the left ventricular outflow tract gradient.

Ventricular Arrhythmia

Ventricular tachycardia and ventricular fibrillation requiring electrocardioversion occurred at a frequency of approximately 1%. Perform continuous electrocardiographic monitoring for 48 hours after the procedure.

Specific Populations

Pregnancy

Risk Summary: The concentrations of alcohol in blood after PTSMA were not measured, but dehydrated alcohol is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation. Maternal use is not expected to result in fetal exposure to the drug.

Clinical Considerations: Dehydrated alcohol for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy. When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period.

Data: Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in humans. The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.

Lactation

Dehydrated alcohol is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation and breastfeeding is not expected to result in exposure of the child to the drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients <60 years old and in patients ≥60 years old showed similar improvement in exercise capacity after ablation. The rate of heart blocks and dysrhythmia increased with age. Permanent pacemaker dependency increased to 34% in patients >60 years old.

Common Adverse Effects

Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation.

General

Dehydrated alcohol is available in the following dosage form(s) and strength(s):

• Injection: 1 mL or 5 mL of ethyl alcohol ≥99% by volume as a clear, colorless liquid in a single-dose glass ampul.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient.

• In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.