ENHANCED PURITY AND METHODS OF USE OF ABLATIVE ALCOHOL
A liquid injectable pharmaceutical drug product consisting of no less that 99 percent ethanol comprised of no less than 99 percent ethanol active pharmaceutical ingredient with a volume of at least 0.05 mL to be injected into a patient as a method of ablating/lysing cells.
1 . A method of reducing septal thickness in a patient, the method comprising:
measuring a left ventricular outflow tract pressure gradient;
placing a guiding catheter into a left main coronary artery and a guidewire into a left anterior descending artery;
placing an over-the-wire balloon of a percutaneous transluminal catheter or over-the-wire percutaneous transluminal coronary angioplasty balloon catheter into a septal artery branch under at least one type of guidance to determine an at least one potential target septal artery;
injecting an angiographic/echocardiographic contrast agent through a central balloon lumen to ensure subsequent injection of a liquid injectable pharmaceutical drug product does not spill into the left anterior descending artery and to verify that a heart region to be infarcted is a portion of a septum responsible for an obstruction in a left ventricular outflow tract;
slowly injecting at least 0.5 mL and up to 5 mL of the liquid injectable pharmaceutical drug product through an at least one lumen of the percutaneous transluminal catheter or over-the-wire percutaneous transluminal coronary angioplasty balloon catheter over the course of 1 to 2 minutes into the target septal artery and keeping the over-the-wire balloon inflated in the target septal artery for at least 2 minutes to prevent spillage; and
removing the over-the-wire balloon and the percutaneous transluminal catheter or over-the-wire percutaneous transluminal coronary angioplasty balloon catheter and any remaining guidewire,
wherein the method reduces septal thickness by at least 2 mm and reduces left ventricular outflow tract pressure gradient by at least 2 mmHg; and
wherein the liquid injectable pharmaceutical drug product consists of no less than 99 percent ethanol consisting of no less than 99 percent of fully synthetic, non-fermented ethanol; and.
2 . The method of claim 1 , further comprising transiently occluding the target septal artery with the over-the-wire balloon to test a transient reduction in left ventricular outflow tract pressure gradient prior to injecting the liquid injectable pharmaceutical drug product.
3 . The method of claim 1 , wherein about 1.45 mL of the liquid injectable pharmaceutical drug product is injected.
4 . The method of claim 1 , further comprising repeating the injecting in another target septal artery.
5 . The method of claim 1 , further comprising re-measuring the left ventricular outflow tract pressure gradient after removing the over-the-wire balloon and the percutaneous transluminal catheter or over-the-wire percutaneous transluminal coronary angioplasty balloon catheter and any remaining guidewire.
6 . The method of claim 1 , further comprising placing a temporary pacing wire in the heart of the patient, when the patient does not have a permanent pacemaker, to help counter a potential transient heart block.
7 . The method of claim 1 , wherein the at least one type of guidance is selected from contrast echocardiographic guidance, fluoroscopic guidance, pressure gradient-fluoroscopic guidance, cardiac magnetic resonance imaging guidance, and contrast-enhanced magnetic resonance imaging guidance, or a combination thereof.