Use Instructions

5.1.3 Atrial Arrhythmias Potentially Caused by CCM Therapy Pulses

Atrial and supraventricular arrhythmias could theoretically be initiated when CCM-induced

ventricular activity is conducted retrograde to the atria, resulting in premature atrial

depolarization. The OPTIMIZER Smart Mini IPG may sense the ventricular activation

resulting from the retrograde-induced atrial event and deliver CCM therapy as

programmed. In addition, strong CCM therapy pulses delivered through leads implanted

in a basal position close to the atria have the potential of directly stimulating the atria. If

CCM therapy causes atrial activation through either of these mechanisms, and the atrial

signal is then conducted to the ventricles, it may look like couplet PACs (AVAV) but the

second complex would be identified as a “PVC” by the OPTIMIZER Smart Mini IPG.

The main variables that may cause CCM therapy pulses to lead to atrial activation are

ventricular lead placement location on the right ventricular septum, CCM pulse amplitude,

and CCM train delay. To prevent the occurrence of atrial arrhythmias due to CCM

therapy pulses, it is recommended that basal lead implant locations be avoided.

The potential for direct atrial activation by CCM therapy pulses can be tested during

implant by setting the CCM pulse amplitude to the highest possible value and extending

the CCM train delay by 20 to 30 ms beyond its recommended setting, while ensuring that

the CCM therapy pulse train, including its balancing phase, remain completely within the

bounds of the ventricular absolute refractory period, then delivering CCM therapy while

monitoring the patient’s heart rhythm for episodes of atrial activation. The testing should

confirm the absence of atrial activation with the increased CCM amplitude and extended

CCM train delay.

In addition to proper lead location and CCM parameter programming, another protective

measure that must be implemented is the programming of the Atrial Tachycardia Rate

(ODO-LS-CCM mode only) to a sufficiently low value to prevent CCM therapy delivery

from inducing atrial arrhythmias while still allowing for the consistent delivery of CCM

therapy.

5.2 Electrocautery

Warning: The use of surgical electrocautery devices, especially of the unipolar kind, can induce

CCM therapy inhibition or can make the OPTIMIZER Smart Mini IPG revert to its

“DOWN” mode (OOO mode, with no delivery of CCM). If the device is found to have

reverted to its “DOWN” mode, it will need to be reset, which will clear the statistical

data stored in the device. The device can be damaged if high energies are coupled

into the system.

Use of electrocautery in close proximity to an implanted OPTIMIZER Smart Mini IPG can also

couple radiofrequency (RF) energy directly through the leads and lead tips into the cardiac

muscle tissue, producing burns or possibly cardiac arrhythmias. If electrocautery is used, brief

signal bursts should be considered, with the neutral electrode positioned such that its affects on

the OPTIMIZER Smart Mini IPG and its attached leads are minimized. The risk of adverse effects

can be decreased by reprogramming the OPTIMIZER Smart Mini IPG into OOO mode. The

patient’s peripheral pulse should be monitored throughout the procedure and correct operation of

the OPTIMIZER Smart Mini IPG should be verified immediately after the procedure.