Risks of spontaneous injury and extraction of an active fixation pacemaker lead: report of the Accufix Multicenter Clinical Study and Worldwide Registry.

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 approximately 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.

Spontaneous versus extraction related injuries associated with Accufix J-wire atrial pacemaker lead: tracking changes in patient management.

UNLABELLED: To make recommendations for management of potentially fatal failure of the Accufix series of atrial J-wire permanent pacemaker leads, we closely monitored the number of injuries and fatalities resulting either from spontaneous fracture of the J-wire or from attempts to extract the lead. In a population of 30,357 patients, 2,298 patients are enrolled in a prospective follow-up Multicenter Study, the remainder are patients with known clinical status from voluntary reporting, and 2,992 patients died following implant. In the remaining 27,365 patients, 6 deaths have been attributed to J-wire related injury (J-inj) while 13 were complications (E-inj) associated with 4,076 lead extraction procedures (3,974 intravascular (intra)/102 primary thoracotomy (PT). The date of occurrences were from 1994 to November 1997. CONCLUSIONS: (1) Since lead extractions were not conducted in a controlled study, it is not known whether the deaths associated with lead extraction is in excess of what would have occurred if these leads had not been removed in this specific subset. (2) Awareness of the procedure related complication rate appears to have moderated the rate of lead extraction and may ultimately lead to management that reasonably balances the risks of patient injury.

Kaplan-Meier analysis of freedom from extraction or death in patients with an Accufix J retention wire atrial permanent pacemaker lead: a potential management tool.

UNLABELLED: Morbidity (36 cases) and mortality (6 cases) have been reported in patients with Accufix J retention wire atrial leads. This has resulted in ongoing patient fluoroscopic monitoring as well as lead extractions. The estimated implanted worldwide population is 40,860. Estimating the size of the remaining population at risk is an important tool for assessing patient management guidelines. RESULTS: The Kaplan-Meier method can be used to calculate the cumulative probability of remaining free of extraction and death for patients based on implant duration. The individual Kaplan-Meier curves for lead extraction and patient survival can also be computed. Based on the Multicenter Study (MCS) population of 2,298 patients, the probability that a patient is alive with the lead still implanted at 5 years implant duration is 52.5%. The event-free survival rate at 5 years implant duration is 81.3%. The corresponding probability of remaining free from injury due to the J-wire is 99.9% at 5 years implant duration. Assuming similar rates of death and extraction, these results can be extrapolated to the world wide population. CONCLUSIONS: The management of Accufix patients must consider patient longevity, the probability of J-wire morbidity/mortality, and the probability of extraction complication morbidity/mortality. The probability of remaining at risk as a function of time from implant can be calculated from the events known in the MCS patient population. These event-free survival estimates can be used to identify subsets of the population at greater or lesser risk based on various clinical parameters.

Cumulative hazard analysis of J-wire fracture in the Accufix series of atrial permanent pacemaker leads.

UNLABELLED: To permit a more complete analysis of J-wire fracture in the Accufix series of atrial permanent pacemaker leads, the time to occurrence of all known fractures and injuries has been redefined relative to the duration of risk exposure, that is, according to the interval of time between implant and occurrence of the event. This redefinition permits application of a cumulative hazards model to the data, which previously has not been explored. Predictors of J-wire fracture can be tested using this method. This also permits parametric curve-fitting for determination of linearity or constancy of risk of events over time. RESULTS: Among 2,063 Multicenter Study (MCS) leads analyzed, 381 fractures of the J-wire were identified. Stratified analysis based on cumulative hazard curves identified a more open shape of the J-wire as predictive of fracture, which supports the results previously reported based on logistic regression analysis. Fitting a Weibull curve to the cumulative hazard of J-wire fracture gives a shape parameter equal to 0.85. This value indicates that the instantaneous hazard of J-wire fracture decreased over time from implant. CONCLUSIONS: (1) The cumulative hazard function can be used to examine predictors of J-wire fracture and preliminary findings support the previously identified predictor of J shape; (2) Based on these analyses, the rate of J-wire fracture appears to decrease slightly as time from implant increases.

Automatic adaptation of the basic pacing rate in response to minute ventilation. Chorum French Investigational Group.

Rate responsive pacing based on minute ventilation (VE) correlates highly with metabolic demand. This type of sensing also recognizes extended periods of rest. The Chorum pacemaker includes a rate responsive algorithm that modulates the basic rate according to phases of activity versus sleep. Forty-six patients (mean age 78 +/- 15), received a Chorum pacemaker for atrioventricular block in 17 cases, sick sinus syndrome in 25, and mixed disorders in 4. Holter monitoring was performed to analyze to heart rate and to examine the circadian adaptation of the minimal pacing rate. The mean basic rate was programmed at 63 +/- 5 beats/min, and the sleep rate at 52 +/- 4 beats/min. Seventeen patients had spontaneous heart rates consistently above the programmed basic rate, and 6 had sustained supraventricular tachyarrhythmias. One-half of the patients had periods of pacing at the programmed sleep rate. The mean diurnal pacing rate was 68 +/- 5 beats/min compared to a mean nocturnal rate of 60 +/- 4 beats/min (P < 0.0001). The average time spent at the basic rate was 37 +/- 30 min (0-110) during daytime (4%), versus 242 +/- 153 min (20-477) at night (45%, P < 0.0001). No adverse effect was observed in this patient population. VE allows a reliable detection of the sleeping periods as well as an adjustment of the basic rate in accordance. Caution is advised in cases of bradycardia dependent tachyarrhythmias.

Circadian variations in minute ventilation can be reproduced by a pacemaker sensor.

Special software allowing the memorization of 24-hour minute ventilation can be loaded into the memory of the Chorus RM, a DDDR pacemaker driven by minute ventilation. This feature was tested in the postimplant period in 13 patients. Measurements of minute ventilation, respiratory rate, and respiratory amplitude were analyzed according to prospectively defined diurnal and nocturnal time periods. Minute ventilation decreased by 39% (P < 0.001) from the diurnal to the nocturnal phase, while respiratory rate and amplitude decreased by 18% and 28%, respectively (P < 0.001 each). Thus, minute ventilation allowed discrimination between sleep and waking hours. This information could be utilized to modulate the backup rate of the pacemaker.

Measurement of minute ventilation with different DDDR pacemaker electrode configurations. Investigators of a Multicenter Study Evaluating the Chorus RM and Opus RM Pacemakers.

A rate responsive minute ventilation (VE) pacemaker was implanted in 49 patients (70.8 +/- 40.0 years). A Chorus RM 7034 pacemaker was implanted in 43 patients and an Opus RM 4534 in six patients. Four sensor configurations were compared: atrial configuration (bipolar atrial lead) in 34 patients; ventricular configuration (bipolar ventricular lead) in 6 patients; unipolar configuration (double unipolar leads) in 6 patients; and floating configuration (VDD single-pass lead) in 3 patients. The patients carried out 57 exercise tests in all with cardiopulmonary recording (CPX). Real VE and oxygen consumption (VO2) were recorded by the CPX, the VE measured by the sensor (VEsensor) was recorded in the pacemaker memory. The mean correlation between VE and VEsensor was 0.90 +/- 0.08 (P < 0.001) and between VO2 and VEsensor was 0.86 +/- 0.10 (P < 0.001). The mean correlation between VE and VEsensor by configuration type were as follows: atrial configuration = 0.89 +/- 0.08; ventricular configuration = 0.95 +/- 0.05; unipolar configuration = 0.87 +/- 0.14; and floating configuration = 0.88 +/- 0.05. In conclusion, VE may be reliably measured using different electrode configurations. A study conducted in a larger population should allow one to conclude that unipolar electrodes can be used in VDDR, AAIR, VVIR, or DDDR modes to measure VE.

Value of automatic processing and reliability of stored data in an implanted pacemaker: initial results in 59 patients.

Stored data in implantable pacemakers have rarely been used as a diagnostic tool because of the complexity. Our group has developed software called AIDA, providing an automatic interpretation of data stored in memories of the Chorus (ELA medical) pacemaker. We compared the results of AIDA analysis to surface ECG Holter interpretation in 59 patients (age 75 +/- 9 years). In 33 cases, neither AIDA nor the Holter found any anomaly. Eleven patients demonstrated episodes of supraventricular tachycardia (SVT), confirmed by AIDA in ten patients; AIDA failure was due to nonsustained episodes of SVT not inducing mode switch. Loss of atrial sensing, pacemaker-mediated tachycardia, and ventricular extrasystoles were detected by AIDA in ten patients. Traditional Holter missed three cases. This initial study confirms that stored pacemaker data, automatically interpreted can provide reliable information over a 24-hour period.