*Senior Resident **Assistant Professor ***Additional
Professor ****Additional Professor & Head
Address for correspondence: Dr.Yashpaul
Sharma, Assistant Professor, Dept. of Cardiology, Postgraduate
Institute of Medical Education and Research, Chandigarh-160012, India.
E-mail: ypspgi@yahoo.com
Abstract
Re-use of DDD pulse generators explanted from
patients died of unrelated causes is associated with an additional
cost of two transvenous leads if implanted as DDD itself, and high
rate of infection according to some studies. We studied the clinical
and economical aspects of reutilization of explanted DDD pacemakers
programmed to VDD mode. Out of 28 patients who received VDD pacemaker
during the period, October 2000- September 2001 in the Department of
Cardiology, PGIMER, Chandigarh, 5 poor patients were implanted with explanted
DDD pulse generators programmed to VDD mode. Each implantation was planned
and carried out according to a standard protocol. The age ranged from
45 to 75 (mean-61) years. The indications for pacing were complete heart
block (4) and second degree AV block (1). The clinical profile, costs and
complications, if any were noted and followed up at regular intervals.
The results were compared with patients who received new DDD pulse generators
during this period. The additional cost for the atrial lead was not required
in these patients. None of these patients had any local site infection.
Compared to the two-lead system, the single lead system provided more rapid
implantation and minimized complications associated with placement of
an atrial lead. The explanted DDD pacemaker can be safely reused as VDD
mode with same efficacy in selected patient population. This is associated
with lower cost and complications compared to reimplantation as DDD itself.
Key words: Explanted pacemakers,
VDD, DDD.
Introduction
Technology is outpacing the financial resources available for health
care all over the world. Pacemakers are among the expensive devices,
and when indicated properly they have no alternative. In many instances
pacemakers outlive the patients and it would be a waste to dispose these
pacemakers that are still in good condition having considerable battery
life left without allowing others to benefit. However the reuse
of pacemakers is associated with widespread technical, medical, ethical
and legal considerations.
Reuse of DDD pulse generators explanted from patients
dying of unrelated causes is associated with an additional cost of
two transvenous leads, if reimplanted in DDD mode itself. There are
also reports of unacceptably high rates of infection associated with
reuse of explanted pacemakers. We studied the clinical and economical
aspects of utilization of explanted DDD pacemakers programmed to VDD
mode.
Materials and methods
During the period October 2000 to December 2001
(15 months) the patients who received pacemakers in PGIMER, Chandigarh
were studied. Out of these patients, those who received generators explanted
from patients who had died of unrelated causes were noted. We used explanted
dual chamber pulse generators (Medtronic, Prodigy DR, model 7860, bipolar)
after programming to VDD mode, with the use of new VDD lead (58-13.5-9F)
in poor patients who could not afford a new pulse generator. Appropriate
preprocedural evaluation was done in these patients to achieve optimal
patient selection for VDD mode. The pulse generators had been explanted
postmortem from patients who died of causes other than pacemaker failure
after informed consent from the nearest relative. The generators were
properly cleansed in antiseptic solution and sterilized with ethylene
oxide and reliably tested for function and battery life. The recipient’s
consent was also sought after proper explanation of the risks and benefits.
These patients were followed up after one month
of implantation initially and three monthly thereafter. They were compared
with those patients who received DDD pacing during the same period
regarding cost, complications and procedural time. To assess the quality
of life (QOL), a standard questionnaire (Table1) was given to
the patients during their last follow up visit of the study period.
The questionnaire contained 7 questions, 3 related to the general QOL
and 4 specific to the pacemaker related symptoms. Each question contained
4 responses, the individual score varying from 1-4 according to severity.
The total score in each patient was calculated.
Table 1: Questionnaire for Quality of
life (QOL) assessment
A: General Quality of Life
1. Inconvenience caused by the procedure
Nil /minimal/moderate/severe
2. Symptoms before and after pacemaker implantation
Disappeared /improved/unchanged/worsened
3. Did you need a change in your profession?
Positive
adjustment/more strenuous work
No adjustment/former
occupation
Minimal adjustment/less
strenuous
Major change/retired
B: Pacemaker related symptoms
Before implantation
After implantation
severe/moderate/mild no severe/moderate/mild/no
1. Fatigue
2. Dizzy spells
3. Palpitation
4. Breathlessness
|
Results
During the study period 136 pacemakers were implanted
in same number of patients in this hospital, which included 53 dual
chamber (DDD 25, VDD 28) and 83 single chamber (VVI/ R 78, AAI/R 5)
pacemakers. Indications for the implantation included sick sinus syndrome
(31), high-grade AV block (94), symptomatic trifascicular block (9)
and cardiomyopathy (2). 21 cases involved reuse of pacemakers, which
included 9 cases of reimplantation in the same patient (pacemaker infection-2,
lead fracture or displacement-5, and pacemaker extrusion-2) and 12 cases
of reuse of pacemakers explanted postmortem (dual chamber-8, single chamber-4).
Out of 8 dual chamber pacemaker generators explanted,
5 programmable DDD pulse generators were reimplanted in VDD mode.
These 5 patients included one female and their age varied from 45 to
75 (mean 61) years (Table 2). Four of them had complete heart
block while one had second-degree Mobitz-type II heart block. The battery
life assessed prior to reuse varied from 43 to 124 (mean 89.4) months.
The average battery voltage at implantation was 2.77 volts. A new VDD
lead (58-13.5-9F), which costs about 20,000/-, was used in all. This reduced
the extra amount spent on the two transvenous leads (2 x 18, 000/- =Rs
36,000/-) by Rs16, 000/- per patient. As the VDD lead required only a single
lead introducer for its insertion, an extra amount of Rs 2,000/- was also
avoided making a net gain of Rs 18,000/-, i.e., 50% of the total expenditure
of refurbishment per patient.
Table 2: Baseline characteristics
Discussion
We studied 5 patients who received explanted DDD
programmable pulse generators, which were programmed to VDD mode prior
to implantation. Analysis of cost effectiveness and safety in these
poor and unaffordable patients revealed that these generators can be
safely and effectively used at a significantly lower cost.
The rationale for the reuse of pacemakers is based
on the following facts. The current lithium battery pacemakers have
an expected life greater than 10 yrs. In high-risk subgroups of patients
with coronary artery disease and atrioventricular block, the 3-year mortality
approaches 60%1
and thus many pacemakers would have more than 5 years of life left when
the recipients die. Pringle et al reported a mortality rate of 58% within
2 years of last generator implant based on a retrospective examination
of 169 consecutive pacemaker patient-deaths2.
It should also be noted that in patients with severe cardiac diseases
such as heart failure and cardiomyopathy, more sophisticated pacemakers
are often implanted, and these patients do die earlier from their original
disease. Thus the waste of pacemaker life is aggravated.
Mugica et al reviewed over 3,500 patients who
had a 10-year follow up and reported no significant difference in the
actuarial survival of those patients given explanted generator compared
to those received newer one 3.
Rosengarten et al observed similar incidence of pacemaker related complications
and survival among new and refurbished pacemakers in a prospective comparative
study over a mean follow up period of 36 months4.
Such experiences have repeatedly confirmed that when properly carried
out, re-use of pacemakers does not pose any additional risk with considerable
reduction in cost. The lack of widespread acceptance of pacemaker re-use
is, therefore, not alone due to technical or medical considerations,
but is related to ethical and legal problems associated with this approach.
The ethical and legal issues involve both the
retrieval of a still usable pacemaker from a deceased patient and
the selection of the patient to receive such a pacemaker. In countries
such as Sweden, pacemakers are considered to be the property of the
state and can be removed routinely without the need for consent from
the families of patients who have died. In many other countries including
Canada, US and India, once the pacemaker has been implanted regardless
of the source of funding for this procedure, the device is considered
to belong to the patient. Retrieval of such a device therefore requires
the consent of the next of kin or the living will of the patient. In view
of theoretical risks of reimplantation of cadaveric explants, informed
consent of the recipient also should be sought, after proper explanation
of possible risks involved in the re-use.
The clinical problem of reuse of pacemaker in
the recipient is mainly based on the rate of infection and battery
life. The risk of re-use is that an instrument might be improperly selected
due to an inaccurate history of use, or improperly cleansed, tested or
sterilized. Explanted pacemakers should be considered for re-use only
when the reliable clinical record indicates that the instrument has had
no malfunction and has an arbitrarily set minimum battery life of 5 years.
After proper electronic testing, the pulse generators are to be washed
under sterile conditions in distilled water and then gas sterilized with
ethylene oxide for two hours at 55°C and 60% humidity. The device is
released for implantation after essential aeration for 48 hours at 55°C
in an aeration device or in the appropriate sterilizer. Mond et al described
a high rate of infection with the reuse of explanted pacemakers5.
Based on a retrospective case control study, which involved 100 patients
who received re-used pacemakers, Linde et al concluded that the re-use
of pacemakers could be carried out without increased risk to the patient
provided a proper routine for technical control and sterilization is followed6.
Experiences of other authors have also confirmed the short- and long-term
safety of re-use of cadaveric explants7,8,9.
None of our patients had local site infection.
Battery life of the pulse generators was properly assessed prior to
implantation by a pacing system analyzer in all. The average battery
life of these 5 pulse generators at the time of implantation was 89.4months
(at 60 bpm, output 4 V, pulse width 0.4 ms and VDD mode). The re-use
as VDD system resulted in avoiding the need of atrial lead placement leading
to reduction in fluoroscopy time and virtual nonexistence of complications
related to atrial lead, apart from reducing the cost significantly.
The cost reduction by Rs 16,000/- per patient was significant
considering the baseline economic status of these poor patients. There
was no significant difference in the duration of hospital stay, need
of antibiotics or additional cost to the patients. Proper atrial sensing,
the most essential component of VDD pacing was also unaltered on follow
up. Similarly, none of these patients had pacemaker syndrome, pacemaker-mediated
tachycardia or atrial arrhythmias on follow up. There was no significant
difference in the quality of life score between those received explanted
pulse generator and newer one.
This study has some limitation in that the patient
sample is small due to obvious problems mentioned. We didn’t assess
the incidence of VVI pacing by Holter monitoring on follow up. However,
with good sinus node function, programmed lower rate of 50 bpm and
good atrial tracking noted at each follow up visit, significant VVI
pacing in between is unlikely, though we cannot categorically deny such
an occurrence. However, this issue is largely overwhelmed by the fact
that most recipients were extremely poor and they were not in a position
to afford anything more than the cost of the new electrode.
The re-use of pacemakers is not carried out routinely,
as many physicians and affordable patients do not encourage it usually.
The manufacturers are also understandably reluctant to participate
in refurbishing used pacemakers and the pacemaker warranty disclaims
liability to anyone except the first recipient. Yokoyama reported that
re-use of explanted pacemaker constituted only 0.1% of all implanted pacemaker
units in Japan in 199210.
The corresponding figures from India are not available.
We could not find many publications on the re-use
of explanted pacemakers from our country. Panja et al noted that the efficacy
of re-used pacemaker was highly comparable to that of newly implanted one
in terms of morbidity and mortality. Re-use in the same patient, but not
reuse of cadaveric explants was associated with high rate of infection
in their study7. Sethi
et al re-used 13 explanted generators out of 42 refurbished pacemakers.
There was no pulse generator failure or adverse reactions among these
during a mean duration follow up of 34 months8.
Balachander et al also reported the safety and efficacy of refurbished
pacemakers in 140 implantations9.
Hence, the pacemaker reuse needs to be encouraged in developing countries
and rationale for reuse should be purely economical.
Concluding, the explanted programmable dual chamber
pacemakers can be safely re-used in VDD mode with same efficacy in
selected patient population, at significantly lower cost.
References
1. Otterstad JE, Selmer R, Strom O, et
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2. Pringle RA, Leman RB, Kratz JM, Gillette PC. An
argument for pacemaker reuse: Pacemaker mortality in 169 patients over 10
years. Pacing Clin Electrophysiol 1986; 9:1295-8.
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arguments in favor of pacemaker reuse. Pacing Clin Electrophysiol 1986;
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4. Rosengarten M, Chiu R, Hoffman
R. A prospective trial of new versus refurbished cardiac pacemakers:
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Mond H, Tartaglia
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6. Linde CL, Bocray A, Jonsson H,
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7.
Panja M, Sarkar CN, Kumar S, et al. Reuse of pacemaker. Indian Heart
J. 1996: 48; 677-80.
8.
Sethi KK, Bhargava
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J. Efficacy and safety of refurbished pacemakers- Report on collaborative
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