Arrhythmia/EP
US registry points to substantial
risk from ICD, pacemaker replacement
May 18, 2009 | Steve Stiles
|
Boston, MA - Three years ago, a Canadian
group made news when they reported a
5.8% three-month rate of major complications related to the replacement of
implantable cardioverter defibrillators (ICDs) that were subject to a safety
advisory or "recall" [1]. Sounds high, said some
implanters, especially in the US. But the numbers from a Canadian Heart
Rhythm Society working group had breached what had been nearly a vacuum
with respect to large-cohort data on the safety of replacing either ICDs or pacemakers.
Attendees at the Heart
Rhythm Society 2009 Scientific Sessions last week got a glimpse of some of
the first such US numbers associated with implanted-device change-outs from a
sizable cohort. A preliminary, unadjusted analysis, presented here by Dr
Marye J Gleva (Washington University School of Medicine, St Louis, MO),
suggested that the risk of major complications from ICD change-outs may
actually be similar north and south of the world's longest shared international
border.
In the analysis of
1031 patients from a multicenter registry called REPLACE, who received
replacement ICDs or pacemakers without planned lead revision or replacement
during a recent one-year period, about 11% developed complications of some kind
over the six-month follow-up; that rate included infections in about 1.3% of
the cohort.
The rate of major
complications, including serious infections or hematomas, was 4.2%. Minor
complications like swelling at the pocket site or need for reprogramming
occurred in 7.3%.
About half the
replacements were of ICDs and half were of pacemakers. The rate of major
complications differed substantially between the two device types, at 6.0% and
2.5%, respectively.
All complications
documented in the registry had been prospectively defined and were
independently and blindly adjudicated, Gleva reported.
Now we have compatible data that should give most
implanters real pause prior to explanting an advisory generator.
The raw numbers
should be considered only hypothesis-generating, she told heartwire,
but already she has heard from colleagues that they seem "higher than
expected." They potentially provide, however, the kind of information
clinicians need to reliably gauge the risks vs benefits of device replacement
when, for example, an ICD or pacemaker is the focus of a safety advisory.
"It's nice to
have US data that is in concert with the Canadian data," REPLACE principal
investigator Dr Jeanne Poole (University of Washington School of
Medicine, Seattle) said to heartwire. "A lot of us couldn't
believe that the complication rate actually might be that high. And now we have
compatible data that should give most implanters real pause prior to explanting
an advisory generator, unless the risk of the problem with that generator is
significant over time."
The presented
analysis didn't look at the cumulative risks of repeated device change-outs,
according to Poole, but "probably for most recalls and advisories, the
risk of explanting and reimplanting new generators is going to be many times
greater than that of following the patient closely."
The 1031 REPLACE
patients received their replacement devices at 68 US centers, had their
surgical wound checked within one to seven weeks, were evaluated at three
months, and had their final clinic visit at six months. Their mean age at
baseline was 71 years; 29% had diabetes, 14% had elevated creatinine; about
half were on aspirin, 11% were taking a thienopyridine, and 37% were on
warfarin.
All received
preoperative antibiotics and antiseptic preparation of the implant site; 82%
received antibiotic irrigation of the pocket, about half had postprocedure IV
antibiotics and half received oral antibiotics after discharge.
They were experienced implanters who have been in the
business a long time. . . . My suspicion is that we won't
see a great variance across different centers.
The 53 major
complications that occurred in 43 patients included device malfunction
requiring reopening of the pocket in 21% of such cases, readmission related to
the new device in 17%, hematoma in 15%, infection in 13%, "prolonged"
hospitalization in 11.3%, pocket revision in 7.6%, and a host of less common
"other" complications in 15%.
Six patients died
within 30 days of the implantation, but at adjudication none were considered to
be a direct result of the procedure, according to Gleva.
The 83 minor
complications experienced by 75 patients included visible swelling in 29% of
the cases, blistering in 19.3%, hematoma in 15.7%, cellulitis and device
reprogramming in 7.2% each, and various "other" ones in 21.7%.
Proportion of
patients with each device type who experienced at least one major or minor
complication
Device |
Major complication (%) |
Minor complication (%) |
All pacemaker |
2.5 |
6.2 |
Single-chamber pacemaker |
2.2 |
7.8 |
Dual-chamber pacemaker |
2.6 |
5.9 |
CRT pacemaker |
0 |
7.1 |
All ICD |
6.0 |
8.4 |
Single-chamber ICD |
5.0 |
8.9 |
Dual-chamber ICD |
4.9 |
7.5 |
CRT-D |
8.0 |
9.1 |
CRT=cardiac
resynchronization therapy, ICD=implantable cardioverter defibrillator,
CRT-D=CRT-defibrillator
To download table as
a slide, click on slide logo above
Both major and minor
complications hit at similar rates for dual- and single-chamber devices,
whether they were pacemaker-only or could defibrillate. But the major
complication rate was sharply higher for ICDs than for pacemakers.
"The centers
that participated in our study all did moderate to high volumes of these
procedures," according to Poole. "And they were experienced
implanters who have been in the business a long time. Although we haven't [yet]
done this analysis, my suspicion is that we won't see a great variance across
different centers. I think [our data] actually do reflect true complication
rates related to routine pacemaker and ICD generator changes."
Biotronik
sponsors the REPLACE registry. Gleva discloses receiving consulting
fees/honoraria and research support from Biotronik and Medtronic. Poole
reports being on the speakers' bureau for Boston Scientific, Medtronic, and
St Jude Medical and receiving research grants from Biotronik. |
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Source
1. Gould PA, Krahn AD, for the
Canadian Heart Rhythm Society Working Group on Device Advisories. Complications
associated with implantable cardioverter-defibrillator replacement in response
to device advisories. JAMA 2006; 295:1907-1911.