The Optimizer Smart implantation is performed in a minimally-invasive procedure under local anesthesia. The new two lead configuration enables an easier implantation and the device can be positioned flexibly since the charging coil is integrated into the IPG header.
The IPG is generally implanted in the right pectoral region. Two right ventricular leads are placed for delivery of Cardiac Contractility Modulation signals. An optional atrial lead may be placed in the right atrial appendage (RAA) or the atrial lateral wall for additional sensing.
The preferred ventricular lead arrangement is for one RV lead to be placed in the anterior septal groove and the other in the posterior groove approximately halfway between the base and apex. If the patient has an ICD, a reasonable distance should be ensured between the Cardiac Contractility Modulation leads and an ICD lead (approximately 2cm). In order to verify correct lead placement, appropriate lead impedances are externally measured after lead placement. Cross-talking tests are also performed to eliminate possibility of adverse interaction between Optimizer and ICD.
The Optimizer IPG is placed into a subcutaneous pocket in the right pectoral region. The recommended maximal depth of implant, for proper device interrogation and charging, is 2.5cm. The leads should form a gentle curve and not be under stress/tension. The IPG should be secured to the fascia using a non-absorbable ligature. The pocket is then closed.
Post implantation device interrogation is performed to assure proper device programming and to rule-out lead dislodgement. Thereafter, the patient receives standard post-operative care for a minimum of 24 hours prior to discharge.