Subcostal Temporary Extracardiac Pacing II Study

Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.

"• Methylprednisolone 125 mg administered over 30 minutes beginning at least 30 minutes prior to the incision and StealthTrac Lead insertion procedure. This intravenous dose can be repeated every 8 hours on day one of the insertion from 1-3 doses depending on the patient's ability to take oral medications. It can be administered daily thereafter until the patient is able to take oral dosing. In normal circumstances, post op day 2, commence oral glucocorticoid (see below for recommended oral dosing).~Oral (PO) glucocorticoid preparations and dosing:~* Prednisone 40-60 mg orally daily based on BMI category. BMI categories: Low (\<18); Medium (18-30); High (\>30). Low and medium are assigned 40 mg daily. High BMI is assigned 60 mg daily dose. This while the StealthTrac lead remains in place.~* Methylprednisolone 16-32 mg daily based on BMI (low, medium and high) while the StealthTrac Lead remains in place."

"Once the first StealthTrac Lead is placed using the procedure described in the AtaCor Temporary Pacing System Instructions for Use (DOC-10085), load a second StealthTrac Lead into the same MACH I Delivery Tool, unless it was damaged during insertion of the first StealthTrac Lead, in which case a new MACH I Delivery Tool should be used.~Insert the second StealthTrac Lead through (1) a different intercostal muscle path within the same intercostal space or (2) within an adjacent intercostal space. Increased electrode spacing is achieved by pacing between the leads."

A single StealthTrac Lead is placed with no additional treatment.