2
YEAR EXPERIENCE WITH THE FRACTAL LEADS POLYROX PX 60-BP (VENTRICULAR)
AND PX 52-JBP (ATRIAL).
J.
Van den Broek,* C. Drossos.
Ballarat
Health Services, Ballarat, Australia, and Biotronik, Australia.
Recent
pacemaker lead development has aimed to reduce energy consumption
and ensure good detection of cardiac signal. The main priorities
in low energy pacing are to reduce the inflammatory reaction at
the lead tip, and to maximise the Electrochemically Active Surface
area (EAS).
Inflammatory
reaction has been reduced by using biocompatible materials (Platinum
alloys and Titanium) and the use of steroid eluting leads.
Further reduction in stimulation threshold has been achieved with
reduction in Geometrical Surface area (GSA), however this is limited
with conventional leads in view of increasing resistance to charge
transfer with reduction in EAS. Iridium fractal surface
treatment increases EAS, with smaller GSA.
Methods:
We entered patients with usual indications to Cardiac Pacing in
a prospective non randomised clinical investigation with an aim
to follow up for 24 months. The Biotronik Polyrox PX 60-BP
and PX53-JBP leads with an Iridium fractal surface were implanted.
We present the data on 17 patients, (12 atrial leads and 17 ventricular
leads) to 24 month follow up.
|
Lead
|
Implant
|
1
mth
|
3mth
|
12mth
|
24
mths
|
|
Atr.
Thresh
|
.6
± .3
|
.9
± .2
|
.8
± .3
|
.6
± .3
|
.6
± .3
|
|
Vent.
Thresh
|
.6
± .1
|
.9
± .3
|
.7
± .2
|
.6
± .2
|
.5
± .2
|
|
P-Wave
Amp
|
3.6
± 2.0
|
2.8
± 1.5
|
2.8
± 1.5
|
3.1
± 1.2
|
3
± 1.1
|
|
R-Wave
Amp
|
12.0
± 1.0
|
10.1
± 4.0
|
11.2
± 4.0
|
11.2
± 3.8
|
9.9
± 3.8
|
|
Atrial
Imp
|
726
± 173
|
465
± 61
|
511
± 85
|
528
± 104
|
568
± 112
|
|
Vent.
Imp
|
474
± 110
|
474
± 110
|
474
± 110
|
474
± 110
|
651
± 98
|
Conclusions:
These thresholds were comparable to thresholds achieved with current
steroid leads and maintained at 24 months, an initial rise was
apparent due to early inflammation which was improving by 1 month
and back to implant levels by 12 months. Advantages with
this lead are low energy pacing, equivalent threshold in unipolar
and bipolar stimulation, superior sensing with application to
rate adaptive pacing algorithms, and may have novel applications
such as early detection of cardiac transplant rejection.