Transcript Poster - Mirko Junge, Homepage

1. Institut für Rechtsmedizin, Universitätsklinikum Hamburg-Eppendorf, Butenfeld 34, 22529 Hamburg, Germany
2. Innere Medizin B, Ernst-Moritz-Arndt Universität Greifswald, Friedrich-Löffler-Str. 23a, 17487 Greifswald, Germany
3. Herz-, Thorax-, Gefäßchirurgie, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
An Anlysis of Pace Makers and Implantable Cardiverter/Defibrillators explanted post mortem
M. Junge1, J. Weckmüller2, H. Nägele3, K. Püschel1, W. Rödiger3
Frequency Distribution of the Different PM/ICD Modells
The functional state and the possible involvement in the death of patients with pace makers
(PM) and impIantable cardioverter/defibrillators (ICD) was examined in a cross-section
analysis in all cases seen in the crematorium Hamburg-Öjendorf, Germany, during the year
2000.
Manufacturer Distribution
25
100
20
80
15308 bodies were examined in the year 2000 during the mandatory second external examination before cremation in the
crematorium Hamburg-Öjendorf, Germany. 212 pace makers (PM) as well as 6 implantable cardioverter/defibrillators (ICD)
were thus explanted in accordance with federal law (Batterieverordnung BattV).
15
60
All generators were examined as to the quality of the electrical output pulses. The generators were telemetrically
interrogated in all cases were possible (197 of 218). In cases where this was not possible, the titanium case was sawn
open, a new battery was connected, and the ‚hybrid‘ was subjected to the standard testing (electrical output measurement,
telemetric interrogation). The statistical analysis was performed using SPSS Version 10.0, student edition.
10
40
5
20
Vitatron
Ventritex
Teletronic
Siemens
Pacesetter
Medtronic
CPI
Sorin Biom.
• Age of the patients when deceased: 84+/-8,6 years
Intermedics
• Age of the patients at generator implantation: 80+/-8,7 years (Diag. 6)
Biotronik
• Mean duration of implantation: 4+/-3,2 years (Diag. 7)
Guidant
0
Ela
0
5985
5989 Mirel VL
7005C
Activitrax 8403M
Actros D
Actros DR
Actros S
Actros SR
Affinity DR
Anmgstrom ICD
Ceryx 3
Ceryx 6
Ceryx I
Chorum
Chorus
Chorus II
Classix 8437
Cosmos II
Dart
Dash
Defender II ICD
Dialog II
Discovery
Dromos DR
Dromos SL
Dromos SR
Elite
Entity DR
Ergos 01
Ergos 02
Ergos 03
Inos CLS DR
Kairos D
Kairos S
Kairos SR
Kappa
Kappa DR
Kappa SR
Legend II
Legend SSIR
Logos
Meridian
Meridian DR
Metros 01
Metros TC-01
Metros TC01
micro Jewel ICD
Mini III ICD
Mini0r 36
miniDual 50
MiniOr100
MiniSwing 200
Minix SSI
Minix ST
Minuet
Multiplog 2040K
Nanos 01
Neos 01
Neos 02
Neos M01
Optima
Opus
Physios 01
Pikos 01
Pikos 01XLP
Pikos E01
Pikos LPE 01
Prevail
Prodigy DR
Prodigy S
Prodigy SR
Programalith III
Reflex
Regency SR
Relay
Saphir II
Sigma
Suprima III
Thera
Thera DR
Thera S
Thera SR
Thermos M02
Thesis
Trios 01
Trios 02
Trios M 01
Unety
Ventrak Mini IV
Vigor DR
Vigor SR
Vita 2 SSI
Vita 710
Results:
Count
Count
Materials and Methods:
Diagram 2:
• Gender distribution: 111 female, 103 male (of 214)
Diagram 1:
• Functional state of the generators (of 214 testable PM/ICD) (Diag. 3):
Frequency distribution of the different pacemaker (PM) and implantable cardioverter/defibrillators (ICD) generators explanted during the year 2000.
- 158 (72.5%) fully functional
Some consolidation has taken place on part of the manufacturers during the
last couple of years, reducing their number considerably. Furthermore a skew in
the data towards Biotronik can be observed for the region of Greater Hamburg,
which is not seen in the sales data for the whole of Germany.
Most generator models were found only once or twice, due to the large number of different models on the market.
- 41 (18.8%) ERI (elective replacement indicator)
- 14 ( 6.4%) EOL (end of life)
4 ( 1.8%) output signal only after telemetric reset of generator
-
1 ( 0.5%) undetermined
Time since last PM/ICD Follow-up before
Death
Functional State of the PM/ICD Generators
200
Last PM/ICD Follow-up / days
• High non-compliance with regard to the follow-up PM/ICD checks (max. 2859 days without
follow-up); Despite this non-compliance the pace maker patients got older than the normal
population (Diag. 4).
150
• PM/ICD generators in residents of old people‘s homes are not better cared for as those
implanted in patients living on their own (Diag. 5).
Number of Cases
100
• In some cases the data stored in the PM/ICD generators could be used to reconstruct the
agonal phase and the time of death.
80
3000
• Many distinct PM/ICD models: 93 different models out of a total of 218 generators (Diag. 1)
• All newer generators with a short duration of implantation worked flawlessly, with one
exception.
Schrittmacherfunktion vs. Wohnort
50
0
Conclusion:
undetermined
• The cause of death has to be examined very thoroughly in cases with a short duration of
implantation.
• The PM/ICD generators have to be telemetrically interrogated in order to clarify the role of
the PM/ICD system with regard to the death of the patient. For this purpose the functional
state of the electrode system has to be assessed as well.
Reset
EOL
ERI
• A prolonged life expectancy can be seen in old and very old patients receiving a PM/ICD
system.
Generator
2000
40
undetermined
1500
1000
Reset
EOL
20
500
fully functional
0
N=
Functional State
5
14
64
EOL
ERI
fully functional
ERI
fully
functional
0
unknown
own home
old people's home
Place of Residence
Functional State of the PM/ICD Generators
Diagram 3:
Diagram 4:
Diagram 5:
Functional state of the 218 PM/ICD generators examined.
Box-Plot diagram of the duration in days since the last telemetric
interrogation of the PM/ICD generator.
PM/ICD-generator function according to place of residence.
158 generators were functioning flawlessly, 41 were in ERI (Elective
Replacement Indicator) state, and 14 were in EOL (End of Life) state.
•The importance of cardiological follow-up checks of the PM/ICD system (generator and
electrodes) has to be communicated to the patients in a more effective manner.
60
2500
Number of Cases
-
Frequency distribution of the PM/ICD generator manufacturers of the
generators explanted during the year 2000 in the crematorium HamburgÖjendorf.
The high quality of the PM/ICD generators is documented by the outliners in
the functional box: One PM generator functioned flawlessly for the whole
duration of implantation—nearly 8 years—without any follow-up. The
generator was still programmed with the factory set-up for implantation.
4 generators were in need of a telemetric reset in order to start
outputting pacing signals. For one device the functional state could not
be assessed, even when using electrical measurements and telemetric
information.
No statistically significant higher numbers of PM/ICD in ERI or EOL state
could be found for deceased living in old peoples homes as compared to
those living on their own.
Most of the patients (81%) had a follow-up check of their PM/ICD within one
year. The check had a positive effect with regard to the functional state.
The complete study can be downloaded from the Internet at:
http://www.DrJunge.de/pdf/PMPS_02.ger_web.pdf
Age at Implantation / Years
5
0
Duration of Implantation / Years
20
15
10
5
0
0
12
24
36
Duration of Implantation / Months
25
Generator
State
20
undetermined
15
Reset
10
EOL
5
ERI
0
fully
functional
15
10
25
30
5
15
30
10
Duration of Implantation / Years
20
Functional state of the Generators
0
15
14
13
12
11
10
9
8
7
6
5
4
0
25
Life Expectancy with / without PM
Life Expectancy at Implantation / Years
N = 190,00
Life Expectancy at Implantation / Years
Std. Dev =
3,21
3
105
100
95
90
85
80
75
70
65
60
55
0
Mean = 4
10
2
N = 190,00
20
1
Mean = 80
Std. Dev =
8,66
Number of Cases
10
50
Number of Cases
30
30
15
20
The First 36 Months
10
40
Frequency Distribution
5
50
Life Expectance with / without PM
0
30
Life Expectance at Implantation / Years
Duration of Implantation
Age at PM/ICD Implantation
Life Expectance with / without PM
Duration of Implantation / Years
Diagram 6:
Diagram 7:
Diagrams 8 and 9:
Diagram 10:
Histogram of the ages of the patients at PM/ICD
implantation.
Duration of PM/ICD implantation in years.
Sunflower-Plot (Diagram 8) of the life expectancy of a statistically normal person of the same age and gender as the PM/ICD patient in the year of implantation,
compared to the observed duration of implantation.
Distribution of the functional PM/ICD generator state after explantation
in relation to the duration of implantation and the life expectancy at the
time of implantation.
The age does not follow a normal distribution; there is a
marked tailing with regard to low age groups.
The implantation dates could only be reconstructed for
190 of the 218 generators examined
A nearly exponential decline in the number of patients is
depicted with regard to the duration of implantation.
Due to the restriction of only 190 known implantation
dates of the total of 218 generators examined, the
duration of implantation could only be calculated for
these 190 cases.
The diagonal line marks the points in the diagram where the expected years at the age of implantations are equal to the observed years lived by the patient. All
data points below the diagonal line mark cases where the duration of implantation was longer than the life expectancy of the normal population at the age of
implantation. Meaning that the PM/ICD patients lived longer than the possibly healthy normal population. All data points above the diagonal line represent
patients who lived shorter than the matched normal population.
The life expectancy for the first 36 month post implantationem is displayed as a scatter-plot in diagram 9.
Corresponding author: mailto:[email protected]
© 2002 Mirko Junge