Spinal Cord Stimulation to treat post-operative AF

See protocol page 13,14.

CABG surgery, could lead to Post-Operative Atrial Fibrillation (POAF) in about
a third of the patients.
During AF, the heart will maintain most of its function since the ventricles
will still work effectively. However, the rate will be slightly less regular,
leading to symptoms such as a racing heart, tiredness or fainting and a reduced
quality of life. Moreover, patients with AF also have a higher risk of having a
stroke than patients without AF. Post-operative AF (POAF) is AF developed
within the first 5 days after the CABG operation. Symptoms could lead to
prolonged hospitalization, of prolonged bladder catheterization and of
medication assumption.

Recent experimental studies have shown that the delivery of low electric
stimuli, to the spinal cord might have a role in protecting the heart from the
occurrence of AF. For this reason we would like to investigate if these
electric stimuli generated by the Spinal Cord Stimulation (SCS) device System
are able to reduce the percentage of AF in the five days after surgery.

See protocol page 19
The primary objective is to determine the occurrence of post-operative AT/AF
between the start of anesthesia and the first 5 days after CABG surgery in
randomized groups, defined as patients in the SCS group and patient in the
control group.

See protocol page 22

This is a prospective pre-market single center clinical research feasibility
study. The study is a non-blinded randomized controlled study with 50 subjects.
Patients in the treatment group will be implanted with a spinal cord lead (n =
25) before surgery. This lead will be connected to an external spinal cord
stimulator (SCS). Patients will be stimulated continuously at the highest
amplitude which is still comfortable for the patient until hospital discharge,
which will be 5 days after surgery. Control patients (n = 25) will be treated
according to clinical practice. End-points will be evaluated at various times
before, during and after surgery up to 5 days after surgery.
Patient will come for a final visit one week after dischage for a final check
(extra visit compared to standard of care).

Half (n=25) of the patients will receive a temporary lead into the spinal cord
and will receive spinal carod stimulation(SCS) for 5 days after the CABG
procedure. Conform the standard procedures for a lead implantation an Xray
will be made to check the lead position.

All patients (n=50) will receive a holter from day 0 to day 5.

See protocol page 65-68.

* Implanting a neurostimulation lead has small risks similar to spinal
procedures, including spinal fluid leak, headaches, swelling, bruising,
bleeding, infection, or paralysis, hematoma on your back where the lead is
inserted.
* If you are on anticoagulation therapy you might be at a greater risk for
postoperative complications such as hematomas that could result in paralysis in
rare cases.
* Adverse effects of stimulation are usually mild and go away when stimulation
is reduced or turned off. These adverse effects could include radicular chest
wall stimulation, uncomfortable stimulation, a jolting or shocking sensation,
or persistent pain at the incision site.
* The lead or extension could migrate within the body or erode through the
skin. There could be undesirable changes in stimulation, possibly related to
cellular changes around the electrode(s), changes in the position of the
electrode(s), loose electrical connections, or lead or extension fractures. It
is also possible that the implanted materials could cause an allergic or immune
system response.
* Your neurostimulation system might unexpectedly cease to function due to
electrical shorts or open circuits, conductor (wire) fractures, and insulation
breaches. These events cannot be predicted.
* In rare cases, excessive tissue growth around the electrode(s) may result in
spinal cord compression and paralysis. Additional surgery is required to treat
these complications, which can occur weeks to years after lead implantation.