(Circulation. 1999;100:2344.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Risks of Spontaneous Injury and Extraction of an Active Fixation Pacemaker Lead
Report of the Accufix Multicenter Clinical Study and Worldwide Registry
From the University of Alabama, Birmingham (G.N.K., R.C.R.), Johns Hopkins University (J.A.B.), Baltimore, Md; University of Southern California (D.T.K.), Los Angeles; Ohio State University (C.J.L.), Columbus; Mayo Clinic Foundation (M.A.L.), Rochester, Minn; Clinique Alleray-Labrousse (G.P.), Paris, France; Accufix Research Institute (J.F., M.K.O., L.G.E.), Denver, Colo; and Medical Data Research Center (G.L.G.), Providence Health System, Portland, Ore.
Correspondence to G. Neal Kay, MD, 321J Tinsley Harrison Tower, University of Alabama at Birmingham, Birmingham, AL 35294.
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Abstract |
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Background—The Telectronics Accufix pacing leads were recalled in November 1994 after 2 deaths and 2 nonfatal injuries were reported. This multicenter clinical study (MCS) of patients with Accufix leads was designed to determine the rate of spontaneous injury related to the J retention wire and results of lead extraction.
Methods and Results—The MCS included 2589 patients with Accufix
atrial pacing leads that were implanted at or who were followed up at
12 medical centers. Patients underwent cinefluoroscopic imaging of
their lead every 6 months. The risk of J retention wire fracture was
5.6%/y at 5 years and 4.7%/y at 10 years after implantation. The
annual risk of protrusion was 1.5%. A total of 40 spontaneous injuries
were reported to a worldwide registry (WWR) that included data from
34 672 patients (34 892 Accufix leads), including pericardial
tamponade (n=19), pericardial effusion (n=5), atrial perforation (n=3),
J retention wire embolization (n=4), and death (n=6). The risk of
injury was 0.02%/y (95% CI, 0.0025 to 0.072) in the MCS and 0.048%/y
(95% CI, 0.035 to 0.067) in the WWR. A total of 5299 leads (13%) have
been extracted worldwide. After recall in the WWR, fatal extraction
complications occurred in 0.4% of intravascular procedures (16 of
4023), with life-threatening complications in 0.5% (n=21). Extraction
complications increased with implant duration, female sex, and J
retention wire protrusion.
Conclusions—Accufix pacing leads pose a low, ongoing risk of injury. Extraction is associated with substantially higher risks, and a conservative management approach is indicated for most patients.
Key Words: pacemakers • pacing • complications
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The Telectronics Accufix active fixation pacing leads were recalled on November 3, 1994, after 2 deaths and 2 nonfatal injuries related to protrusion of an electrically inactive J retention wire had been reported.1 2 3 4 5 6 7 8 In these patients, the J retention wire had fractured and protruded from the polyurethane insulation, resulting in laceration of the right atrium. The J retention wire was subsequently demonstrated to have the potential to embolize to the pulmonary circulation.9 10 11 As a consequence of the recall, many of these leads have been extracted by procedures that are associated with significant morbidity and mortality.12 13 14 15 16 17 18 19 20 21 More recently, other models of Telectronics pacing leads incorporating a preshaped J retention wire within the central conductor coil have been identified as posing a risk of similar injuries.
Although several pacing leads have been recalled for unacceptably high rates of failure, the nature of the risk posed by the Accufix leads is quite different. In contrast to other pacing leads that exhibit insulation failure or conductor fracture, Accufix leads cannot be simply abandoned and replaced. Rather, to eliminate the risk of injury, these leads must be removed by procedures associated with significant morbidity and mortality. The management of patients with an Accufix lead confronts patients and physicians with risk-benefit issues that are analogous to those with recalled heart valves.22 23 To determine the clinical course of patients with Accufix leads and to establish methods for detecting J retention wire fracture, this Multicenter Clinical Study (MCS) was designed to prospectively follow a large cohort of patients in whom these leads had been implanted. This report from the MCS details the information available on the clinical outcome of patients in the MCS and those reported in a worldwide registry (WWR) of patients implanted with an Accufix lead.
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Methods |
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Multicenter Clinical Study
A total of 44 897 Accufix leads (models 329-701, 330-801, and 033-812) were distributed between 1988 and 1994, of which
91%
(41 000) were implanted. The MCS included 2589 patients in whom 2612
Accufix leads had been implanted or were fluoroscopically screened at
12 centers in the United States (n=7), Europe (n=4), and Canada (n=1)
on or before September 30, 1996. Patients in the MCS were invited to
undergo cinefluoroscopic imaging of their leads every 6 months. The
lead-related variables that were prospectively collected include
date of manufacture and J retention wire material (Elgiloy or MP35N),
cinefluoroscopic shape of the lead (true J shape, almost J shape, L
shape, and almost straight), and range of motion during the cardiac
cycle parallel and transverse (swing) to the plane of the J retention
wire (minimal, mild, moderate, or extreme).
Fracture Classification
At each cinefluoroscopic screening, the J retention wire was
classified as class 1, no fracture; class 2, fracture of the J
retention wire without protrusion; class 3, protrusion of the J
retention wire; or class 4, migration or embolization of any portion of
the J retention wire.24 25 26 The Physician Advisory
Committee proposed an initial set of management strategies in 1994 that
were based on clinical judgment in the setting of limited data
regarding the relative risks of injury from J retention wire protrusion
and lead extraction. These recommendations were revised as data became
available and advised consideration of lead extraction when there was a
protruding J retention wire, when the patient was <60 years of age, or
at the insistence of the patient. A conservative approach was
recommended for leads with J retention wires that were fractured
without protrusion; a case-by-case approach was advised for leads with
a migrated J retention wire. Management of patients in the MCS was left
to the individual physicians and patients involved but was generally
within the context of the Physician Advisory Committee recommendations.
Injuries and Extraction Complications
The occurrence of injuries related to the J retention wire in
the MCS before the recall was determined by review of medical
records. After the MCS was initiated, patients were evaluated by
clinic visit every 6 months. Lead extraction data were prospectively
collected, with complications classified as major if there was
mortality or morbidity, including requirement for an additional
surgical procedure, infection, cardiac arrest, admission to an
intensive care unit, blood transfusion, or other high level of medical
intervention. Minor complications included those that extended the
procedure time, caused additional discomfort to the patient, or
adversely affected quality of life. Extracted leads were inspected to
determine the status of the J retention wire and returned to the
manufacturer (Telectronics) and later to the nonprofit Accufix Research
Institute for analysis.
In addition to the MCS, a voluntary registry of injuries related to the J retention wire and the outcome and complications of lead extraction was established and maintained by the Accufix Research Institute.
Statistical Methods
Data regarding the MCS population were compiled from November
1994 through April 12, 1999. Comparisons were performed by use of
t tests and ANOVA or their nonparametric
equivalents for continuous variables and 
2
or Fisher’s exact test for categorical variables. The
Wilcoxon rank-sum or Kruskal-Wallis test was used to compare
ordinal categorical variables. Multivariate
analyses were performed by use of stepwise logistic regression.
Time-related events, such as patient survival and J retention wire
injury, were analyzed by use of the Kaplan-Meier method with
comparisons using the log-rank statistic. Because the exact date that a
change in fracture classification occurred between 2 consecutive
cinefluoroscopic screenings could not be known with precision, a
nonparametric generalization of the Kaplan-Meier estimate
proposed by Turnbull27 and a parametric
method that assumes a Weibull distribution of time to event were used
for time-related analyses. Cumulative hazard curves (the
negative logarithm of the event-free survival function) were generated
to present the risk of time-related events (J retention wire
fracture, protrusion, and injury). Projection of future events was
based on MCS data with the Gompertz28 distribution.
Although the MCS provides substantial information on fracture and protrusion, because of the rarity of J wire injury (2 cases in the MCS), statistical estimates of injury were based on the 40 injuries reported worldwide. The cumulative hazard curve represents only a potential risk of J retention wire injury. The competing risk of mortality in elderly patients from other causes is high, and most patients will not live long enough to experience a lead-related injury. The cumulative incidence of injury is an estimate of the risk of actually experiencing an injury during a patient’s remaining lifetime.29 Because the risk of injury appeared to be relatively constant through 8 years after implantation, Poisson regression with age and sex covariates was used to determine the cumulative incidence of J retention wire injury. Combining the Gompertz28 model for survival and the Poisson model for injury resulted in a family of cumulative incidence of injury curves stratified by age at implant and sex. The cumulative risk of fatal or life-threatening extraction complications was determined by fitting a logistic regression model to the postrecall intravascular extraction data with use of the risk factors of sex and logarithm of implant duration. The cumulative risk of extraction complications was then compared with the cumulative incidence of injury curves to determine potential thresholds of extraction versus injury risk.
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Results |
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A total of 2612 Accufix atrial leads were implanted in 2589 patients (58.5% men and 41.5% women) at the 12 MCS centers between 1988 and November 1994. The WWR included data for 34 672 additional patients with 34 892 Accufix leads. The age of the MCS population ranged from 4 to 105 years (mean, 68.8±14.2 years) at the time of lead implantation, somewhat younger than the WWR (71.7±12.4 years, P<0.0001). As of April 12, 1999, the mean age of the MCS population who remained alive with an implanted lead was 75.3±12 years (range, 9 to 98 years), with 869 patients (34%) having died and 643 patients (25%) having undergone lead extraction The age distribution of the patients at continued risk for J retention wire injury is shown in Table 1
. Among the remaining
1077 patients (41%), 847 were undergoing active follow-up with
cinefluoroscopy. At the latest follow-up, a total of 230 patients were
not undergoing active cinefluoroscopic surveillance because of marked
physical or mental limitations or other contraindications to lead
extraction. The observed (Kaplan-Meier) and estimated (Gompertz)
survival curves for the entire MCS population are shown in Figure 1. The observed probability of survival
was 65% at 5 years after lead implantation and 37% at 10 years. The
survival 15 years after implantation was projected to be 14%.
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J Retention Wire Fracture Classification
The cumulative risk of J retention wire fracture is shown in
Figure 2. On the basis of combined
fluoroscopic imaging and analysis of returned leads, there were
459 fractured J retention wires among 2023 leads (23%) at the most
recent evaluation. At the most recent fluoroscopic imaging (n=1938),
78.6% of the leads were in class 1, 16.3% were in class 2, 4.5% were
in class 3, and 0.5% were in class 4. The risk of J retention wire
fracture has decreased slightly over time from 5.6%/y at 5 years after
implantation to 4.7%/y at 10 years after implantation. Thus, at 10
years of follow-up, the cumulative risk of fracture was 56%. The
risk of protrusion of the J retention wire was constant over time,
1.5%/y (Figure 3). Thus, the
cumulative risk of protrusion was 15% at 10 years after lead
implantation. If the lead was initially in class 2, the risk of
progressing to protrusion decreased from 8.7%/y at 5 years after
implantation to 6.3%/y at 10 years (P=0.03).
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Predictors of J Retention Wire Fracture
The shape of the lead on fluoroscopy and the absence of prior
cardiac surgery were predictive of both time to fracture and protrusion
of the J retention wire by univariate analysis
(Table 2 and Figure 4). In addition, a subclavian implant
approach and any lead swing predicted J retention wire fracture but not
protrusion. By multivariate analysis, J shape,
lead swing, and prior cardiac surgery were independent predictors of
fracture, with patients having a true J shape, no lead swing, and prior
cardiac surgery at lowest risk of fracture. Because of the low event
rate, there were no significant multivariate models for
J retention wire protrusion.
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Injuries Related to the J Retention Wire
As of April 12, 1999, a total of 40 spontaneous injuries related
to an Accufix lead had been reported to the Accufix Research Institute,
including 2 patients in the MCS and 38 patients in the voluntary WWR
(Table 3). There were 6 deaths directly
attributable to a protruded J retention wire. In each case of injury in
which the J retention wire could be examined, there was a clear class 3
fracture with protrusion of the wire through the right atrium into the
pericardial space. In 2 patients, the J retention wire had penetrated
the aortic wall.
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No spontaneous injuries have been observed in the MCS population after
enrollment in the prospective strategy of cinefluoroscopic screening.
In the WWR, injuries were reported before any screening fluoroscopy in
24 patients and after initiation of fluoroscopic screening in 14
patients, including 2 deaths (Table 4).
Figure 5 illustrates the cumulative
hazard of J retention wire injury in the MCS and the entire WWR as a
function of duration after lead implantation. The risk of injury in the
MCS was 0.020%/y (95% CI, 0.0025 to 0.072); in the WWR, the risk was
0.048%/y (95% CI, 0.035 to 0.067). The risk of injury (Figure 6) ranged from 0.156%/y for patients
<50 years of age (95% CI, 0.071 to 0.297) to 0.025%/y for patients
>70 years of age (95% CI, 0.011 to 0.047). Because older patients
have a significantly higher risk of mortality from competing causes (a
lower expected lifetime in which to experience the risk of injury from
the J retention wire) and a lower intrinsic risk of injury, their
future probability of injury decreases progressively with time (Figure 7). The probability of future injury,
conditional on the fact that no injury had occurred until the
present, is projected to decline for all age groups in the MCS.
For patients >50 years of age, the projected risk of a future
injury declines over time to a level that is significantly lower than
the risk of a major complication of lead extraction.
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Lead Extraction
Within the MCS population, extraction of an Accufix lead was
attempted after recall in 642 patients (25%). The primary extraction
procedure involved an intravascular technique in 632 patients (98%)
and a primary thoracotomy in 10 patients (2%). The voluntary WWR has
received reports of attempted lead extraction after recall in 4262
patients, including 4136 patients (97%) with an intravascular
procedure and 126 (3%) patients with a primary thoracotomy. An
additional 395 leads were extracted before recall, leading to a total
of 5299 leads that are known to have been removed (13% of all leads).
The complications of lead extraction are shown in Table 5. Major extraction complications from an
intravascular approach after lead recall have included 16 deaths,
usually as a result of a tear in the superior vena cava or subclavian
veins or myocardial perforation leading to pericardial tamponade.
Nonfatal, life-threatening, and other major complications included
pericardial tamponade (19 patients), hemothorax or pneumothorax (19
patients), vascular injuries treated medically (5 patients) or
requiring surgery (14 patients), and requirement for a secondary
thoracotomy (41 patients). The risk of fatal or life-threatening
complications was significantly higher with a primary thoracotomy than
with intravascular extraction (3.4% versus 0.9%, P=0.02).
The risk of a major complication increased progressively with implant
duration (P=0.0001; Table 6).
By multivariate analysis, the predictors of
life-threatening or fatal extraction complications were longer implant
duration (odds ratio, 1.3 compared with each prior year; 95% CI, 1.1
to 1.5), female sex (odds ratio, 3.5; 95% CI, 1.7 to 7.9), and
protrusion of the J retention wire (odds ratio, 2.7; 95% CI, 1.3 to
5.3).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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Although several models of pacing leads have been recalled for unacceptably high rates of failure, the nature of the risk posed by the Accufix leads is fundamentally different. Although leads with insulation failure or conductor fracture may result in loss of pacing function with catastrophic sequelae, those leads can be abandoned with little additional risk to the patient once they have been replaced with a new lead. In contrast, the Accufix leads must be explanted to remove the risk posed by the J retention wire. Because extraction of pacing leads is associated with significant morbidity and mortality, the risks of spontaneous injury and extraction must be weighed for each patient individually when appropriate management is being considered. These considerations are analogous to those facing patients and physicians when deciding on the proper management of recalled heart valves.22 23 The MCS and WWR indicate that the risk of J retention wire protrusion has been a relatively constant rate over time. Despite this, the risk of spontaneous injury may be decreasing while the risks associated with extraction are increasing with longer implant duration. Furthermore, because the population implanted with these leads is now quite elderly (median age, 78 years), the balance of risks favors a conservative management approach for most patients.
Fracture of the J Retention Wire
The natural cardiac motion of the beating right atrium creates
cyclic stresses on the J retention wire, which leads to metal fatigue.
In general, the greater the cardiac motion, the greater the amplitude
of the cyclic stress. In addition to cyclic stress, the J retention
wire is under a mean stress as a function of its shape within the
heart. The cyclic and mean mechanical stresses imposed on the J
retention wire have been studied in patients implanted with an Accufix
lead through biplane cinefluoroscopic and 3-dimensional
reconstruction.30 Leads with an open J shape had a greater
mean stress than leads with a closed J shape. The combination of stress
amplitude and mean stress during the cardiac cycle was near the limits
of metal fatigue in 5 of 8 patients whose leads were studied by
finite-element analysis during rest and exercise. When one
considers that there are >1 million cardiac cycles every 10 days
(assuming an average heart rate of 70 bpm), these in vivo mechanical
studies indicate a high likelihood of J retention wire fracture given a
sufficient implant duration. Leads under the greatest stress will
fracture with fewer cardiac cycles; those with lower stress may not
fracture during the expected lifetime of the patient. The time-related
analysis of the MCS population suggests a cumulative fracture
rate of 56% at 10 years of follow-up, confirming the predictions of
these in vivo engineering studies. The clinical variables
associated with J retention wire fracture (open shape of the lead) also
correlate well with these finite-element analyses.
Spontaneous J Retention Wire Injuries
The most frequent injuries associated with the presence of an
Accufix lead have been related to laceration of the atrial
myocardium by a protruded J retention wire, resulting in
pericardial tamponade. Although 6 deaths have been reported, the true
incidence of fatal complications from this lead is likely to be
considerably higher because of difficulties in the diagnosis of a
protruding J retention wire without high-resolution imaging. This is
highlighted by the recognition that several cases of previously
unexplained pericarditis or pericardial tamponade could be attributed
to the J retention wire only in retrospect after formal recall of the
Accufix leads. The inability to diagnose a protruding J retention wire
on most routine chest radiographs is also likely to have resulted in an
underreporting of injuries. The reduction in the reports of injury
after widespread publicity of the risks posed by the Accufix leads
suggests that the risk of injury may be decreasing. Indeed, in the MCS,
there have been no injuries since November 1994 despite serial
cinefluoroscopic imaging. The voluntary WWR has received only 1 injury
report over the last 17 months. The mechanism for this apparent
decrease in the risk of injury over time is not clear but may relate to
a lower mechanical stress on the J retention wire for leads that
fracture later than for those that fracture earlier. Whether the
program of cinefluoroscopic screening of these leads and the
recommendations of the Physicians Advisory Committee for selective
extraction have resulted in a decrease in the risk of spontaneous
injury is uncertain. It is clear, however, that an Accufix lead that is
intact on cinefluoroscopy continues to present a risk to the
patient: There have been 1 death and 4 nonfatal cases of pericardial
tamponade since the lead was classified as class 1 between 3 and 13
months earlier. The risk of injury appears to be highest for patients
<50 years of age (0.156%/y) and lowest for patients >70 years of age
(0.025%/y). Patients having undergone prior cardiac surgery, in whom
the presence of pericardial adhesions may limit the potential risk of
pericardial tamponade, may be at an even lower risk of injury.
Extraction Risks
Extraction of the Accufix leads has been accompanied by
significant complications, including 16 deaths among 4023 intravascular
procedures (0.4%). The risk of life-threatening or fatal extraction
complications increases with the duration of lead implantation, female
sex, and protrusion of the J retention wire. It is likely that the
risks of extracting the remaining Accufix leads may be higher than
those observed so far because the minimum implant duration of these
leads is now 
4.5 years. Although new technologies have become
available for lead extraction that have made it possible to remove more
leads with an intravascular approach, these advances have yet to be
proved safer than older techniques. In fact, of the 16 deaths resulting
from extraction of an Accufix lead, a laser technique was used in 4
patients. When these observations are balanced with the relatively low
risk of spontaneous injury from the J retention wire and the advancing
age of the population at risk, a conservative management strategy
appears to be warranted for most patients. The Physician Advisory
Committee has recommended that leads with a protruding J retention wire
be considered for extraction unless the clinical status of the patient
would preclude the procedure. Although this approach has been
associated with a very low risk of spontaneous injury in the MCS, class
3 leads pose a greater risk of extraction complications, and the
balance of these competing risks is unclear even in this subgroup.
Because of an increased duration of exposure to J retention wire
injury, patients <40 years of age who are otherwise in good health
should be considered for elective extraction, especially because the
risks of extraction increase with each year that the lead has been
implanted.
Utility of a Cinefluoroscopic Screening Program
The MCS has allowed an appreciation of the risks of J retention
wire fracture, protrusion, and spontaneous injury and the outcome of
lead extraction. However, despite a greater understanding of these
factors, the overall utility of a strategy of screening and selective
extraction for limiting injuries to the patient has not been
conclusively proved. Although 16 deaths have been related to extraction
of Accufix leads and only 6 deaths to spontaneous injury, it is likely
that the rate of spontaneous injury has been underreported. It is also
likely that there would have been further spontaneous injuries if many
of the extracted leads had not been removed.
Conclusions
Accufix atrial pacing leads have a high rate of J retention wire
fracture. Results of these analyses suggest that a conservative
approach is warranted for most patients with these leads, supporting
the initial recommendations of the Physicians Advisory Committee in
1994. Despite the high risk of J retention wire fracture, the
conditional probability of injury from an Accufix lead is considerably
lower than the risks associated with lead extraction for most
patients.
Received March 30, 1999; revision received July 19, 1999; accepted July 29, 1999.
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References |
|---|
|
TopAbstractIntroductionMethodsResultsDiscussionReferences |
|---|
1. Glikson M, Von Feldt LK, Suman VJ, Hayes DL. Clinical surveillance of an active fixation, bipolar, polyurethane insulated pacing lead, part I: the atrial lead. Pacing Clin Electrophysiol. 1994;17:1399–1404.[Medline] [Order article via Infotrieve]
2. Hayes DL, Lloyd MA, Holmes DR Jr. Counseling and management of patients with Telectronics 330-801 Accufix leads. Pacing Clin Electrophysiol. 1995;18:1595. Letter.[Medline] [Order article via Infotrieve]
3. Brinker JA. Endocardial pacing leads: the good, the bad, and the ugly. Pacing Clin Electrophysiol. 1995;18:953–954.[Medline] [Order article via Infotrieve]
4. Lloyd MA, Hayes DL, Holmes DR Jr. Atrial "J" pacing lead retention wire fracture: radiographic assessment, incidence of fracture, and clinical management. Pacing Clin Electrophysiol. 1995;18:958–964.[Medline] [Order article via Infotrieve]
5. Parsonnet V. The retention wire fix. Pacing Clin Electrophysiol. 1995;18:955–957.[Medline] [Order article via Infotrieve]
6. Ardesia RJ, Saliba BC, Schoenfeld MH. Evolution of fracture in the atrial "J" lead retention wire. Pacing Clin Electrophysiol. 1995;18:2227–2228.[Medline] [Order article via Infotrieve]
7. Sulke N, Chambers J, Blauth C. Life-threatening degeneration of the Accufix active-fixation atrial-pacing electrode. Lancet. 1995;346:25–26.[Medline] [Order article via Infotrieve]
8. Lee WL, Kong CW, Lin MR, Wang JJ, Chan WL, Wang SP, Chang MS. Malfunction of an active fixation J-shaped screw-in atrial electrode lead: a case report. Pacing Clin Electrophysiol. 1997;20:2026–2028.[Medline] [Order article via Infotrieve]
9. Kao HL, Wang SS, Chen WJ, Huang SKS, Lee UT. Migration of a fractured retention wire in the pulmonary artery from an active fixation atrial lead. Pacing Clin Electrophysiol. 1995;18:1966–1967.[Medline] [Order article via Infotrieve]
10.
Gerstenfeld EP, Balarajan Y, Cooke R, Mittleman RS.
Migration and right atrial perforation of an Accufix atrial lead
retention wire following partial lead removal during myomectomy.
Chest. 1998;114:637–639.
11. Mucha E, Catalano P, Myers T. Fracture and migration of a pacemaker atrial lead retention wire found by fluoroscopic screening in an asymptomatic patient. South Med J. 1996;89:798–800.[Medline] [Order article via Infotrieve]
12. Caudill CC, Clinch B, Krueger SK, Gard JR, Turk KT, Wilson CS. Percutaneous extraction of a fractured, exposed atrial "J" lead retention wire. Cathet Cardiovasc Diagn. 1996;37:342–346.[Medline] [Order article via Infotrieve]
13.
Saito H, Zuguchi M, Miura M, Shinozaki S, Hata M,
Tabayashi K. Percutaneous removal of a fractured and
extruded Telectronics Accufix atrial retention wire: new approach
preserving pacing function. AJR Am J Roentgenol. 1996;167:1334–1336.
14.
Telfer EA, Olshansky B, Cadman C, Prater SP, Lanzarotti
C, Miles RH, Blakeman BP. Telectronics 330–801 atrial lead extraction
via the subclavian approach. Ann Thorac Surg. 1997;64:175–180.
15.
Jessurun C, Sung C, Massumi A. Extraction of an Accufix
atrial J-shaped support wire. Circulation. 1997;95:2587.
16. Saibil EA. Removal of a fractured retention wire of an Accufix "J" pacemaker lead with an Amplatz goose neck snare. J Vasc Interv Radiol. 1996;7:367–369.[Medline] [Order article via Infotrieve]
17. Daoud EG, Kou W, Davidson T, Niebauer M, Bogun F, Castellani M, Chan KK, Goyal R, Harvey M, Strickberger A, Man CK, Morady F. Evaluation and extraction of the Accufix atrial J lead. Am Heart J. 1996;131:266–269.[Medline] [Order article via Infotrieve]
18. Lloyd MA, Hayes DL, Stanson AW, Holmes Jr. DR. Snare removal of a Telectronics Accufix atrial J retention wire. Mayo Clin Proc. 1995;70:376–379.[Abstract]
19. Lloyd MA, Hayes DL, Holmes DR, Stanton AW, Espinosa RE, Osborn MJ, McGoon MD. Extraction of the Telectronics Accufix 330–801 atrial lead: the Mayo Clinic experience. Mayo Clin Proc. 1996;71:230–234.[Abstract]
20. Kennergren C. First European experience using excimer laser for the extraction of permanent pacemaker leads. Pacing Clin Electrophysiol. 1998;21:268–270.[Medline] [Order article via Infotrieve]
21.
Furman S. Invited commentary. Ann Thorac
Surg. 1997;64:180.
22. Lindblom D, Bjork VO, Semb BKH. Mechanical failure of the Bjork-Shiley valve: incidence, clinical presentation, and management. J Thorac Cardiovasc Surg. 1986;92:894–907.[Abstract]
23.
van der Meulen JHP, Steyerberg EW, van der Graaf Y, van
Herwerden LA, Verbaan CJ, Defauw JJAMT, Habbema JDF. Age thresholds for
prophylactic replacement of Bjork-Shiley convexo-concave
heart valves: a clinical and economic evaluation.
Circulation. 1993;88:156–164.
24. van Hemel NM, Defauw JJAM, Ruiter JH. Second report of the Dutch committee for monitoring atrial-J retention wire fractures. Cardiologia. 1997;4:164–166.
25. Saliba B, Ardesia RJ, John RM, Venditti FJ, Schoenfeld MH. Predictors of fracture in the AccufixTM atrial "J" lead. Am J Cardiol. 1997;80:229–231.[Medline] [Order article via Infotrieve]
26. Lloyd MA, Hayes DL, Holmes DR Jr. Serial fluoroscopic evaluation of a pacing lead. Pacing Clin Electrophysiol. 1996;19:501–504.[Medline] [Order article via Infotrieve]
27. Turnbull BW. The empirical distribution function with arbitrarily grouped, censored and truncated data. J R Stat Soc B. 1976;38:290–295.
28. Gompertz B. On the nature of the function expressive of the law of human mortality, and on the new mode of determining the value of life contingencies. Philos Trans R Soc Lond A Biol Sci. 1825;115:513–580.
29. Grunkemeier GL, Anderson RP, Miller DC, Starr A. Time-related analysis of nonfatal heart valve complications: cumulative incidence (actual) vs Kaplan-Meier (actuarial). Circulation. 1997;96(suppl II):II-70–II-74.
30. Hoffmann KR, Williams BB, Esthappan J, Chen SY, Carroll JD, Harauchi H, Doerr V, Kay GN, Eberhardt A, Overland M. Determination of 3D positions of pacemaker leads from biplane angiographic sequences. Med Phys. 1997;24:1854–1862.[Medline] [Order article via Infotrieve]
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 Conservative Approach for Extraction of Accufix Leads Journal Watch Cardiology, January 21, 2000; 2000(121): 10 - 10. [Full Text]
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