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Background: Cardiac resynchronisation therapy (CRT) improves outcomes in selected patients with heart failure and left ventricular dysfunction. One mechanism of benefit is believed to be favourable ventricular remodelling. Whether CRT also decreases the frequency of ventricular arrhythmias and risk of sudden death is unknown., Objective: To determine the effect of CRT on frequency of ventricular arrhythmias and appropriate ICD therapies., Design: Retrospective cohort study., Setting: Single-centre, tertiary care facility (Mayo Clinic)., Patients: 52 patients (46 male), aged 70 (SD 10) years, who underwent upgrade from an implantable cardioverter defibrillator (ICD) to a CRT-defibrillator were included., Interventions: Upgrade of ICD to CRT-defibrillator., Main Outcome Measures: Frequency of ventricular arrhythmias prior to and following upgrade to CRT device., Results: Ejection fraction increased from 22% (SD 8%) to 27% (SD 11%) following CRT. However, the frequency of non-sustained ventricular arrhythmias, sustained ventricular arrhythmias, and ventricular fibrillation was not significantly changed prior to and following CRT (2.38 (SD 9.78) vs 58.51 (SD 412.73) per patient per month, p = 0.66; 0.07 (SD 0.17) vs 0.16 (SD 0.52), p = 0.70; 0.05 (SD 0.12) vs 0.25 (SD 1.40), p = 0.12)., Conclusions: CRT is not associated with a decrease in the frequency of ventricular arrhythmia or appropriate device therapy. Thus, use of CRT alone is not beneficial in decreasing the frequency of ventricular arrhythmias or the risk of appropriate ICD therapies.

We report the occurrence of a triboelectric phenomenon (static electricity) that mimicked malfunction of a contemporary pacemaker by creating an electrocardiograpic artifact virtually identical to the pacemaker stimuli. The diagnosis was established by observing a subtle overshoot of the questionable deflection that was absent from pacemaker stimuli.

Clinicians who provide care for patients with implantable devices for rhythm management, ie, pacemakers and internal cardioverter defibrillators, must be aware of sources of interference that could affect device function. Intracardiac radiofrequency is a recognized source of potential interference. However, radiofrequency to extracardiac sites that are relatively close to the implanted device has not been investigated thoroughly. We present 2 patients with permanent pacemakers undergoing intrahepatic radiofrequency for the treatment of metastatic disease. No interference was documented in either patient. Additional in vitro and in vivo studies are needed to determine definite clinical guidelines for such patients.

Objective: To determine whether children with pallid breath-holding spells associated with bradycardia can be treated safely and successfully with permanent pacemaker implantation., Methods: The records of pediatric patients who had apparent breath-holding spells and associated bradycardia and were treated with permanent pacemaker implantation were reviewed., Results: Ten pediatric patients with apparent breath-holding spells associated with bradycardia were treated with a permanent ventricular demand pacemaker at the Mayo Clinic between 1985 and 1995. Patients had onset of symptoms between ages 6 days and 12 months and presented for evaluation between ages 12 months and 5 years. Duration of spells was 15 seconds to 10 minutes. Medications to prevent spells were unsuccessful. Electrocardiograms documented asystolic pauses of 1.7 to 24 seconds (mean: 11.9 seconds). Permanent ventricular demand pacemakers were implanted at 10 months to 5 years of age (median: 14.5 months): 9 endocardial and 1 epicardial. Three patients required pacemaker revision. At follow-up of 38 to 170 months (median: 65.5), 5 patients had complete resolution of spells, 2 had only mild color change without loss of consciousness or seizure activity, and 3 continued to have minor brief spells., Conclusions: Permanent pacemaker therapy for children with pallid breath-holding spells associated with severe bradycardia is safe, efficacious, and warranted.

Dual-chamber pacing improved hemodynamics acutely in a subset of patients with left ventricular (LV) dysfunction but conveyed no long-term symptomatic benefit in most. More recently, LV pacing and biventricular (multisite) pacing have been used to improve systolic contractility by altering the electrical and mechanical ventricular activation sequence in patients with severe congestive heart failure (CHF) and intraventricular conduction delay or left bundle branch block (LBBB). Intraventricular conduction delay and LBBB cause dyssynchronous right ventricular and LV contraction and worsen LV dysfunction in cardiomyopathies. Both LV and biventricular cardiac pacing are thought to improve cardiac function in this situation by effecting a more coordinated and efficient ventricular contraction. Short-term hemodynamic studies have shown improvement in LV systolic function, which seems more pronounced with monoventricular LV pacing than with biventricular pacing. Recent clinical studies in limited numbers of patients suggest long-term clinical benefit of biventricular pacing in patients with severe CHF symptoms. Continuing and future studies will demonstrate whether and in which patients LV and biventricular pacing are permanently effective and equivalent and which pacing site within the LV produces the most beneficial hemodynamic results.

Objective: To determine whether a device (Urologix Targis system) used for transurethral microwave treatment interferes with sensing, pacing, and arrhythmia detection by permanent pacemakers and implantable cardioverter-defibrillators (ICDs)., Methods: We tested 13 pacemakers in both bipolar and unipolar sensing configurations and 8 ICDs in vitro. Pacemakers and ICDs were programmed to their most sensitive settings. Energy outputs of the microwave device were typical of those used clinically. The probe of the microwave device was anchored 1.2 cm from the pacemaker or ICD being tested., Results: No sensing, pacing, or arrhythmic interactions were noted with any ICD or any pacemaker programmed to the bipolar configuration. One pacemaker (Guidant Vigor 1230) showed intermittent tracking when programmed to the unipolar configuration., Conclusions: Most patients with permanent pacemakers or ICDs can safely undergo transurethral microwave therapy using the device tested. Pacemakers and ICDs should be programmed to the bipolar configuration (if available) during therapy. The pacemaker or ICD should be interrogated before and after therapy to determine whether programming changes occurred as a result of treatment. However, our findings suggest that this is unlikely.

The medical community has no independent source of timely information regarding the performance of pacemaker and ICD pulse generators and leads. Accordingly, the authors established an Internet-based registry of pacemaker and ICD pulse generator and lead failures (www.pacerandicregistry.com). During the first year, they found three previously unreported device problems that were promptly communicated to the participants. Of the failures reported, 11% of ICD and 10% of pacemaker pulse generator failures were heralded by signs other than the expected elective replacement indicator (ERI). Average ICD battery longevity was 4.0 +/- 0.7 years, and average dual chamber pacemaker battery longevity was 6.8 +/- 2.6 years. Disrupted insulation accounted for 54% of pacemaker and 29% of ICD lead failures. Compared to pacemaker pulse generator and lead failure, ICD device failures were more likely to cause severe clinical consequences. In conclusion, an Internet-based registry is feasible and capable of providing timely data regarding the signs, causes, and clinical consequences of pacemaker and ICD failures.

Background: Indications for extraction of an abandoned pacemaker lead (APL) are controversial. The purpose of this study was to determine whether or not APLs should be extracted in the absence of pacemaker-related problems., Methods and Results: We retrospectively reviewed, from 1977 through 1998, all patients with retained, non-functional leads and identified 433-266 males and 167 females. Mean age at initial pacemaker implantation was 68[emsp4 ]years. These patients received a total of 259 atrial and 948 ventricular leads. Of the total of 1,207 leads, 611 became non-functional. A total of 531 non-functional leads were abandoned, of which 18 were later extracted: one APL in 345 patients, two in 78, and three in 10. Indications for new lead placement when non-functional leads were abandoned included capture and/or sensing failure (243), lead recall (177), lead fracture (86), pacing system replacement to the contralateral side (11), accommodating patient growth (5), pacemaker function upgrade (5), replacement with implantable cardioverter defibrillator (ICD, 2), interference with ICD (1), and unknown (1). Complications that were associated with pacemakers were found in 24 patients (5.5%)-pacemaker system infection (8 patients) and venous occlusion at the time of a subsequent procedure of new lead placement when APLs had already been in place (16) which resulted in APL extraction (7) or transfer of the pacemaker system to the contralateral side (9). Neither venous thrombosis nor other complications were found in the remaining 409 patients (94.5%). The incidence of complications was higher in patients with three APLs than in patients with two or fewer APLs (40% vs. 4.7%, P=1x10(-6)), in patients with four or more total lead implantations than in patients with three or fewer total lead implantations (26.2% vs. 0. 6%, P<1x10(-10)), and in patients with three or more procedures of new lead placements than in patients with two or fewer procedures of new lead placements (36.4% vs. 3.9%, P=1x10(-10)). Patients with complications were younger than those without complications both at the time of initial pacemaker implantation (59+/-16 vs. 68+/-17 y, P=0.01) and when non-functional leads were abandoned (63+/-15 vs. 71+/-16 y, P=0.04). Mean numbers of APLs, total leads implanted, and procedures of new lead placement were significantly larger in patients with complications than in those without complications (1.58+/-0.78 vs. 1.2+/-0.44, 4.96+/-1.23 vs. 2.66+/-0.8, and 2.13+/-0.85 vs. 1.25+/-0.53, P=0.03, 4x10(-9) and 4x10(-5), respectively)., Conclusions: 1. With only 5.5% of patients having had pacemaker-related complications, the adverse outcome of APL is small. 2. Clinical clues to the possible occasion for pacemaker-related complications include three or more APLs, four or more total leads, three or more procedures of new lead placement, and a younger age at initial pacemaker implantation. 3. Patients with a large number of APLs, total lead implantations, and procedures of new lead placement should be carefully observed to detect possible pacemaker-associated complications.

Minute ventilation-sensing pacemakers enable the paced heart to respond to an increased workload. Two patients with such a pacemaker developed pacemaker-driven tachycardia when connected to an electrocardiogram (ECG) monitor also capable of documenting ventilatory frequency and ECG lead disconnection. This tachycardia stopped when the ECG leads were removed. These pacemakers and monitors emit a low-amplitude electrical current and measure the resultant impedence signal across the chest. When patients are connected to the monitor the pacemaker sensor summates both impedence signals and the paced heart rate is increased as a result.

The procedure of lead removal has recently matured into a definable, teachable art with its own specific tools and techniques. It is now time to recognize and formalize the practice of lead removal according to the current methods of medicine and the health care industry. In addition, since at this time the only prospective scientific study of lead extraction is the PLEXES trial, we suggest that studies relating to the techniques of and indications for lead extraction be designed. Recommendations for a common set of definitions, for a framework of training and reviewing physicians in the art, for general methods of reimbursement, and for consistency among clinical trials have been made. Implementation of these recommendations will require additional effort and cooperation from practicing physicians, medical societies, hospital administrations, and industry.

Background: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath., Methods and Results: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size., Conclusions: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.

Since 1990, 558 Medtronic 5524 bipolar, silicone-insulated, J-shaped, tined, steroid-eluting atrial leads have been implanted at the Mayo Clinic (Rochester, MN, USA) and the Midelfort Clinic (Eau Claire, WI, USA). Implantation data were favorable, with pacing thresholds at implantation (median threshold, 0.6 V) better than most published data on other atrial leads. The rate of acute lead-related complications (dislodgment and diaphragmatic pacing) necessitating reoperation or electrical abandonment of the atrial lead was 0.9%. This rate is lower than that in most published series of atrial leads. Over a median follow-up time of 17.5 months (up to 69 months), there were no chronic lead-related complications and no definite or suspected failures of lead material. This rate is much lower than that with other atrial leads studied previously. We conclude that the Medtronic 5524 atrial lead combines the reliability of silicone insulation with a lack of chronic complications and high thresholds due to its steroid elution and with stability in the atrium due to its J shape despite a passive fixation mechanism. There is no evidence of lead material failure during up to 6 years of follow-up.

Since 1990, 1,068 Medtronic 5024 bipolar, silicone-insulated, tined, steroid-eluting ventricular leads have been implanted at the Mayo Clinic (Rochester, MN) and Midelfort Clinic (Eau Claire, WI). Implantation data were favorable: median pacing thresholds of 0.5 V at 0.5 ms, median R wave of 13.4 mV, and median impedance of 593 omega. Of the 2.1% acute lead-related complications (dislodgment, microdislocation, diaphragmatic pacing, and undersensing), 1.2% necessitated reoperation. This rate is lower than that in most published series of other leads. During a median follow-up of 23 months (up to 76 months), 12 (1.1%) chronic lead-related complications (high thresholds, loss of capture, and undersensing) and no instances of definite or suspected lead material failure occurred. This rate is much lower than that in studies of other leads. Thus, the 5024 lead combines the reliability of silicone insulation with a low rate of chronic complications that is probably the result of its steroid elution. No evidence of failure of lead material has appeared up to 6 years after implantation.

Objectives: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction., Background: Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments., Methods: A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications., Results: Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS)., Conclusions: Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Indications for permanent pacemakers have expanded in recent years. The American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for implantation of cardiac pacemakers were recently updated and now include several of the newer indications. Greatest interest about newer applications of pacemaker therapy focuses on hypertrophic obstructive cardiomyopathy, dilated cardiomyopathy, and pacing for the prevention of atrial fibrillation. Pacing for neurocardiogenic syncope remains controversial despite emerging data. Pacing for long QT syndrome, pacing after cardiac transplantation, and pacing for hemodynamic improvement in the occasional patient with first-degree atrioventricular block and hemodynamic compromise also warrant attention. Available clinical data are discussed in the context of the recent ACC and AHA guidelines.

Current use of newer implantable cardioverter-defibrillators (ICDs) has changed the spectrum of pacemaker-ICD interactions and provided new tools for testing and understanding those interactions. Testing for pacemaker-ICD interactions was performed in 31 procedures involving 22 patients. The protocol included: (1) evaluation of pacemaker stimulus artifact amplitude and its ratio to that of the evoked ventricular electrogram, (2) testing for inhibition of ventricular fibrillation (VF) detection by the ICD during asynchronous pacing at maximum output, (3) evaluation by pacemaker event marker recordings of pacemaker sensing behavior while programmed to nonasynchronous mode during ventricular tachycardia (VT) or VF, and (4) evaluation of postshock interactions. Inhibition of detection of VT/VF was found in 6 of 22 patients (27.2%). Large stimulus artifact amplitude (>2 mV) or stimulus artifact:evoked QRS ratio > 1/3 had a positive predictive accuracy of 18% and 14.4%, respectively, and a negative predictive accuracy of 100% and 92.3%, respectively, for clinically significant interaction. Asynchronous pacing occurred in 16 of 31 procedures (51.6%), and was due to underdetection by the pacemaker in 4 of 16 (25%) and noise reversion in 12 of 16 (75%). Postshock phenomena occurred in 6 cases, 3 of which were clinically significant. Overall, 11 of 22 patients (50%) had clinically significant interactions discovered by this protocol, which led to system revisions in 6 and to pacemaker output reprogramming in 5. Thus, pacemaker-ICD interactions are frequently detected using a thorough and systematic protocol. Most cases can be managed by system revision or pacemaker reprogramming.

Unlabelled: Bradycardia support by ICDs has been limited to fixed rate, ventricular pacing. Concomitant placement of a pacemaker and an ICD exposes a patient to potentially life-threatening device interactions. ICDs capable of dual chamber pacing have recently become available. The number of ICD recipients who stand to benefit from the addition of dual chamber pacing is debated, but no data have addressed this question. This retrospective study analyzed all patients who received nonthoractomy ICD system placement at the Mayo Clinic in Rochester, MN between March 1991 and October 1996 in order to determine the proportion of patients in whom a dual chamber pacing ICD may be indicated., Definitions: (1) Definitely indicated = pacemaker present at ICD implant or NASPE Class I pacing indication; (2) Probably indicated = NASPE Class II pacing indication, NYHA Functional Class III or IV, or history of systolic congestive heart failure; (3) Possibly indicated = history of paroxysmal atrial fibrillation or an ejection fraction < or = 20%. The results were that nonthoracotomy ICDs were placed in 253 patients. A dual chamber ICD would have been definitely indicated in 11% of the study group, probably indicated in 28%, and possibly indicated in 14%. Chronic atrial fibrillation was present at ICD implant in 6.7% of patients and developed in 0.9%/yr during follow-up. The addition of dual chamber pacing to ICDs stands to potentially benefit approximately half (53%) of ICD recipients. These data do not address all patients who may benefit from dual chamber sensing.

Numerous types of interactions between pacemakers and implantable cardioverter defibrillators (ICDs) have been described. Pacemaker outputs preventing appropriate detection of ventricular tachycardia or ventricular fibrillation by the ICD is one of the more serious. Asynchronous pacemaker activity during ventricular arrhythmias may be caused by either nonsensing of the arrhythmia or by noise reversion, which is an algorithm that causes the pacemaker to switch to asynchronous pacing when repetitive sensing at a high rate occurs. We analyzed the mechanisms underlying asynchronous pacemaker activity in ventricular arrhythmias using pacemaker telemetry during the arrhythmia. Thirty-nine induced arrhythmias from 26 different procedures in 19 patients with both pacemakers and ICDs were analyzed. Of the 39 arrhythmias, asynchronous pacemaker activity occurred in 16. The underlying mechanism was nonsensing in 4 episodes and noise reversion in 12 episodes. Clinically significant interference with detection arose on three occasions. Conditions favoring the occurrence of noise reversion include specific pacemaker models, arrhythmia cycle lengths in the range causing noise reversion of the individual pacemaker model, long noise sampling periods, and VVI pacing mode. Noise reversion can be diagnosed by telemetering the pacemaker marker channel during ventricular arrhythmias as a part of routine pacemaker-ICD interaction evaluation. It can be prevented or minimized by programming short ventricular refractory periods or using pacemakers with short retriggerable refractory periods.

The purposes of this study were to define predictors of long-term pacemaker dependency in patients having permanent pacemakers implanted shortly after cardiac surgery, and to evaluate short- and long-term results and survival in this population. Data from 120 adult patients with implantation since 1980 were retrospectively analyzed. Acute and chronic complication rates (4.2% and 16.6%, respectively) were not higher than those expected in the general paced population. In addition, continuous rhythm was evaluated by use of pacemaker inhibition in a subgroup of 20 patients to verify the validity of clinical criteria for pacemaker dependency. Of the patients evaluated for dependency, 41% eventually became nondependent. Prolonged monitoring with an inhibited pacemaker confirmed the accuracy of our method of clinical evaluation of pacemaker dependency. Significant predictors of long-term pacemaker dependency were complete atrioventricular block as the indication and bypass time of > 120 minutes (by multivariate and univariate analyses, respectively). Postoperative complete atrioventricular block is the most important predictor of pacemaker dependency, enabling an earlier decision on permanent pacemaker implantation (no later than the sixth and the ninth postoperative days for wide-complex and narrow-complex escape, respectively). Further prospective studies are needed to define optimal implantation times for indications other than complete atrioventricular block.

Dual-chamber pacing may improve short-term hemodynamics and functional class in some patients with congestive heart failure, even in the absence of conventional indications for pacemaker implantation. However, the impact of different pacing modes on survival of patients with congestive heart failure is controversial. In this retrospective study we analyzed survival data from 546 elderly patients, aged 70 years and older, who underwent implantation of a permanent dual-chamber (DDD, n = 62, DVI, n = 102) or single-chamber (VVI) pacemaker (n = 382) between 1980 and 1985. Survival was further analyzed according to the presence of absence of congestive heart failure, and pacemaker mode (DDD vs. DVI vs. VVI). Overall, dual-chamber pacing (DDD and DVI) was associated with a more favorable long-term outcome when compared with single-chamber ventricular pacing, although differences were only significant for DDD pacing (P = 0.002). When patients with and without preexisting congestive heart failure were analyzed separately, survival following dual-chamber pacing (DDD and DVI) was significantly better than survival following single-chamber pacing in patients without congestive heart failure (P = 0.03), but not in patients with preexisting heart failure (P = 0.139). When patients were analyzed according to the electrophysiological indication for pacemaker implantation, overall survival of patients with AV block (P = 0.0025) but not sinus node dysfunction (P = 0.346) was improved with dual-chamber pacing. This survival advantage in patients with AV block following dual-chamber pacing was lost in the presence of heart failure (P = 0.11). These findings suggest that dual-chamber pacing, in particular DDD pacing, improves the survival in elderly patients without preexisting congestive heart failure. In contrast to the short-term hemodynamic improvement observed in selected patients with congestive heart failure, dual-chamber pacing in elderly patients with congestive heart failure, paced for conventional indications, is not associated with improved survival when compared with single-chamber ventricular pacing.

Background: A growing body of evidence suggests that electromagnetic interference may occur between cardiac pacemakers and wireless hand-held (cellular) telephones, posing a potential public health problem. Electromagnetic interference may occur when the pacemaker is exposed to an electromagnetic field generated by the cellular telephone., Methods: In this multicenter, prospective, crossover study, we tested 980 patients with cardiac pacemakers with five types of telephones (one analogue and four digital) to assess the potential for interference. Telephones were tested in a test mode and were programmed to transmit at the maximal power, simulating the worst-case scenario; in addition, one telephone was tested during actual transmission to simulate actual use. Patients were electrocardiographically monitored while the telephones were tested at the ipsilateral ear and in a series of maneuvers directly over the pacemaker. Interference was classified according to the type and clinical significance of the effect., Results: The incidence of any type of interference was 20 percent in the 5533 tests, and the incidence of symptoms was 7.2 percent. The incidence of clinically significant interference was 6.6 percent. There was no clinically significant interference when the telephone was placed in the normal position over the ear. Interference that was definitely clinically significant occurred in only 1.7 percent of tests, and only when the telephone was held over the pacemaker. Interference was more frequent with dual-chamber pacemakers (25.3 percent) than with single-chamber pacemakers (6.8 percent, P<0.001) and more frequent with pacemakers without feed-through filters (28.9 to 55.8 percent) than with those with such filters (0.4 to 0.8 percent, P=0.01)., Conclusions: Cellular telephones can interfere with the function of implanted cardiac pacemakers. However, when telephones are placed over the ear, the normal position, this interference does not pose a health risk.

Implantation of a permanent pacemaker is an accepted mode of therapy for symptomatic bradyarrhythmias. Application of pacemaker technology for the treatment of cardiomyopathies has generated considerable interest and enthusiastic support in recent years. In both hypertrophic cardiomyopathy and dilated cardiomyopathy, dual-chamber pacing has been shown to decrease symptoms and improve hemodynamics; however, not all patients will benefit from dual-chamber pacing. Technical considerations must be acknowledged in order to obtain optimal benefit with dual-chamber pacing. In addition, other more accepted therapies are available for patients with symptomatic cardiomyopathies. The purposes of this article are to review critically the current literature on the use of dual-chamber pacemakers in patients with either hypertrophic or dilated cardiomyopathy and to provide a clinical perspective based on current knowledge.

The use of wireless communication devices has increased rapidly, with current industry estimates of 50,000,000 subscribers of cellular telephone services, a number that is expected to double by the year 2000. Because wireless communication devices emit RF signals, they have the potential to interfere with implantable devices. The mechanism of interference and the magnitude of interference must be considered in terms of the type of wireless communication device being used and the characteristics of the individual implantable device that is exposed to the RF emission of the cellular phone. This article reviews the potential effects of wireless communication devices on implantable devices and makes initial recommendations for patients with implantable devices.

Since 1989, 136 Medtronic 4058 and 4058M bipolar atrial screw-in leads have been implanted at the Mayo Clinic. Early lead related complications included dislodgment in 4 (2.9%). Over a median follow-up time of 14.4 months (1 day to 3.3 years), there were 11 lead related complications (undersensing, failure to capture, diaphragmatic pacing, and gross lead dislodgment). Chronic complications resulted in reoperations in four patients (2.9%). Of 77 patients in whom pacing thresholds were measured between 2 and 4 months after implantation, 9 (11.7%) and 2 (2.6%) had high pacing thresholds and very high thresholds, respectively. The Kaplan-Meier estimate of the probability of 1-year complication-free lead survival was 93.5%. There were no lead material failures. We conclude that the 4058/4058M lead implanted in the atrial position has favorable acute and chronic performance data, with a tendency toward high pacing thresholds at 3 months. The cause of this phenomenon and its course over time should be further evaluated.

A recall of the Telectronics Accufix 330-801 atrial lead was issued in November 1994, because of fracture of the "J"-shaped retention wire. To assess the integrity of the retention wire, we have performed fluoroscopic screening on 209 patients with the Accufix 330-801 atrial lead in place. Cine films of all 135 patients originally classified as normal were reevaluated after the original screening. Eighty patients have undergone two serial fluoroscopic evaluations separated by 158 +/- 5.4 days. Nine retention wires originally classified as normal were reclassified as fracture without protrusion, and two were reclassified as fracture with protrusion when the original films were reevaluated. Eight of the 11 leads reclassified were screened during our first 2 days of fluoroscopic evaluation of this lead. Of the 80 patients who underwent a second fluoroscopic screening, 70 were initially classified as normal (9 of which were reclassified as described above), 1 fractured, and 9 indeterminate. There were no new fractures detected in this group, and the fractured retention wires did not appear to change during this observation period. We conclude that there is a definite learning curve associated with fluoroscopic evaluation of this lead, and continue to recommend that screening be performed by cardiologists experienced in fluoroscopic screening. Fractured retention wires remained stable in appearance during this observation time. No new retention wire fractures were detected; however, longer follow-up will be required before the incidence of retention wire fracture can be determined.

Objective: To document a cumulative experience with removal of the Telectronics 330-801 Accufix atrial lead after it was withdrawn from the market., Design: We reviewed our results with 96 attempted lead extraction procedures through Dec. 1, 1995., Material and Methods: All patients underwent preoperative assessment, including fluoroscopic screening of the lead. Patients had blood typing and screening done before the extraction procedure, and extractions were performed with cardiac surgical intervention available. Pacing dependence was assessed to determine the need for temporary pacing., Results: The mean patient age was 65.7 +/- 1.6 years and the mean duration of lead implantation was 31.0 +/- 1.4 months. Of the 96 lead extractions attempted, 94 were successful. Of the 96 cases, the retention wires were normal in 29, fractured without protrusion in 34, and fractured with protrusion in 33. Fifty-three leads were removed with use of simple traction only, and seven leads were removed by using a locking stylet and telescoping sheaths. The Cook workstation was used in the removal of 32 leads through the femoral vein; in 1 of these 32 patients, the retention wire was removed before lead extraction. The retention wire was removed but the lead was left intact in one patient. One lead was removed during an opertive maze procedure. Associated complications were minimal., Conclusion: Although lead extraction is a potentially fatal procedure, the Telectronics 330-801 Accufix atrial lead can be extracted safely with minimal morbidity when performed by experienced personnel.

Unlabelled: In November 1994, Telectronics Pacing Systems issued a voluntary recall of their Accufix 330-801 and 329-701 "J"-shaped atrial pacemaker leads. To assess the integrity of the lead, 156 consecutive patients with the Accufix 330-801 atrial lead implanted underwent fluoroscopic screening. Leads were visualized in at least two orthogonal views. When identified, fractured retention wires were classified into one of four groups, depending on the degree of wire extrusion outside of the lead insulation., Results: Of the 156 patients, 35 patients (22.4%) had a definite retention wire fracture, and an additional 13 patients (8.3%) had indeterminate leads. Neither the age of the patients, the time since lead implant, nor the site of fracture correlated with the incidence of wire fracture. When analyzed to include indeterminate leads that were re-evaluated and found to be fractured, as well as two leads that were identified as being radiographically normal but found to be fractured after extraction, the incidence of retention wire fracture is 25.6% (40 of 156 leads evaluated)., Conclusions: The incidence of retention wire fracture in the Accufix 330-801 lead is significantly higher than originally reported. Patients should be notified of the potential dangers associated with this lead. Cardiac digital fluoroscopy is an effective method of screening for wire fracture. Leads with fractured retention wires should be extracted and those with normal fluoroscopic appearance should undergo regular fluoroscopic screening.

A multicenter study was undertaken to determine the failure rate of a specific bipolar tined polyurethane ventricular pacing lead, the Medtronic 4004/4004M pacing lead. Seven centers in the United States and Canada implanted 586 Medtronic 4004/4004M pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The Kaplan-Meier estimate of the percentage of 4004/4004M lead failures within 4 years after implantation was 14.1% (95% confidence interval: 8.5%-19.3%). Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with previous impedance measurements. The observed rate of failure is unacceptable, and strong consideration should be given to replacing the 4004/4004M pacing lead in pacemaker dependent patients and closely monitoring nondependent patients.

A voluntary recall of the Telectronics Accufix models 330-801 and 329-701 "J"-shaped atrial pacemaker leads has been issued because of fracture and extrusion of the J-shaped retention wire. Such extrusion can result in laceration of the atrium or surrounding vascular structures. Herein we describe a patient with a fractured and extruded retention wire that was snared and removed percutaneously; the atrial lead was left intact, and pacing function was satisfactory. This unique procedure can be used to avoid the morbidity associated with percutaneous lead extraction or thoracotomy and to prevent potential dislodgment and embolization of the retention wire during lead extraction.

Permanent pacing can prevent recurrent symptoms and reduce mortality in elderly patients with symptomatic high-degree atrioventricular (AV) block. However, long-term survival with respect to comparable control subjects has not been well defined. In our study, relative long-term survival and prognostic predictors after permanent pacemaker implantation for symptomatic high-degree AV block were assessed among all residents of Olmsted County, Minnesota, who were > or = 65 years old. Of the 154 patients, 77 were men and 77 were women (mean age 80 +/- 7 years). Follow-up was 0.1 to 19.8 years (mean 4.2 +/- 2.8). Sixty-nine patients had isolated AV block and 85 had coexisting heart disease. Observed survival at 1, 3, 5, and 10 years was 85%, 68%, 52%, 21%, and 72%, 50%, 31%, 11% for patients with isolated AV block and patients with coexisting heart disease, respectively (p = 0.006). Observed survival in patients 65 to 79 years old with isolated AV block was comparable to age- and sex-matched cohorts (p = 0.53), but in patients aged > or = 80 years, it was less than that for control subjects (p = 0.014). In patients with coexisting heart disease, observed survival was less than that for control subjects in patients 65 to 79 years old (p < 0.001) and > or = 80 years (p < 0.001). Multivariate analysis identified congestive heart failure, chronic obstructive pulmonary disease, age, syncope, insulin-dependent diabetes mellitus, and male gender as independent predictors of increased mortality.

Since 1989, 72 Telectronics 330-201 active fixation, polyurethane insulated ventricular leads (Accufix) have been implanted at the Mayo Clinic. There were four (5.6%) acute lead related complications (perforation, microdislodgment, and macrodislodgment), three of which led to early reoperation. Over a follow-up time of up to 2.7 years (median 9.4 months), there were six (8.3%) chronic lead related complications but no failures of lead material. Most of these complications developed during the first month, and half of them were transient, with documented improvement later. Two patients (2.8%) required reoperation for chronic complications. At follow-up examination of the pacing thresholds, usually performed about 3 months after implantation, 14.3% of the examined patients had high pacing thresholds necessitating high-output programming. The mechanisms and later evolution of this phenomenon should be further evaluated.

Since 1989, 168 Telectronics model 330-801 active fixation, polyurethane insulated atrial leads (Accufix) have been implanted at the Mayo Clinic. There were four (2.4%) acute lead related complications, (i.e., perforation, microdislodgment, and pericarditis). Over a median follow-up time of 7.6 months (up to 2.7 years), there were 14 (8.3%) chronic complications, including 1 instance (0.6%) of definite lead failure. Most of these complications were early (within the first month) and transient. Four patients (2.4%) required reoperation for chronic complications. During follow-up, 23% of the examined patients had high pacing thresholds, most at about 3 months after implantation, necessitating high-output programming. The exact mechanism and natural history of this phenomenon should be further investigated.

This article reviews recent studies, chapters, and review articles describing advances in cardiac pacing. Initially we discuss expanding and controversial pacing indications, including neurocardiogenic syncope and hypertrophic as well as dilated cardiomyopathies. Recent contributions to the understanding of factors influencing pacing mode selection are then discussed, including survival and atrial fibrillation in the various modes, the hemodynamic importance of atrioventricular synchrony and adaptive atrioventricular intervals, the importance of rate adaptation, the development of pacemaker syndrome, pacemaker response to the development of atrial arrhythmias, and special pacing modes such as VDD and AAIR. Finally, recent advances in rate-adaptive sensors and algorithms are reviewed, including preliminary results with dual sensors.

Several techniques exist for percutaneous extraction of chronic pacemaker leads. To establish the efficacy of the Dotter retriever and pigtail catheter, we reviewed the removal of 59 endocardial pacemaker leads in 42 patients (mean age 71 years). The mean duration of lead implantation was 44 months (range 1-169 months). Thirty-two leads were withdrawn with simple traction alone, and five leads were abandoned when traction failed. The remaining 22 leads were manipulated with a Dotter retriever or pigtail catheter, or both. Twelve leads were dislodged from the endocardium with simple traction (10) or with traction transmitted through an entwining pigtail catheter (2), but they could not be fully withdrawn. Eleven of these leads (92%) were then successfully extracted with the Dotter retriever. Seven of the remaining 10 leads were successfully dislodged and removed by the Dotter retriever. Overall, 9 of 12 leads (75%) that could not be dislodged from the endocardium with simple traction were removed with a Dotter retriever or pigtail catheter, or both. Three patients in whom no catheter method worked required thoracotomy for removal of infected leads. No complications resulted from use of the Dotter retriever or pigtail catheter. We conclude that the Dotter retriever and pigtail catheter have moderate efficacy for dislodging chronic endocardial leads. Once mobilized, however, the leads can be withdrawn with great success with the Dotter retriever. Newer technology should not result in the abandonment of this proven technique.

The field of cardiac pacing has expanded rapidly in recent years. Engineering improvements and microprocessor technology have resulted in a vast increase in pacemaker technology. The "high-tech" edge of cardiac pacing often discourages all but the pacemaker specialist from approaching a malfunctioning pacemaker. Electrocardiographic signs of pacemaker malfunction can be grouped into four categories: failure to output, failure to capture, undersensing, and inappropriate pacemaker rate. For each of these categories, there may be true malfunctions and pseudomalfunctions. In addition, environmental sources of electromagnetic interference, both within and outside the hospital environment, can result in pacemaker malfunction. Approaching pacemaker malfunction with these categories in mind should help minimize confusion.

Although rate adaptive pacemakers are now frequently prescribed, there is limited information regarding long-term follow-up of patients with a pacemaker capable of rate adaptation. We have examined our patients in whom a pacemaker capable of rate adaptation via a sensor that determines minute ventilation has been implanted. After following a group of 42 patients for a mean of 13.2 months we have found this to be a reliable rate adaptive pacing system. The sensor was reliable long term, the system is easy to program, and sensor settings were changed infrequently.

A clear understanding of the components of the pacemaker timing cycles is crucial to understanding and interpreting paced electrocardiograms. The information given in this article provides basic rules for timing cycles for pacing modes currently in use and pacing modes less frequently used but of importance in understanding current timing cycles. Although understanding basic timing cycles allows interpretation of most paced electrocardiograms, manufacturer-dependent variations of the timing cycle operation make it necessary to be intimately familiar with the design of each pacemaker to be interpreted.

Energy consumption and longevity of modern pacemakers are determined by the controlling electronic circuitry and by the stimulation energy. While with technological progress the electronics' energy consumption has been reduced significantly, clinical practice shows that many cardiac pacemakers are programmed to suboptimal settings with regard to minimization of pacing energy consumption. Several methods for optimizing pacemaker output settings have been proposed in the past. The most promising concept is an output parameter optimizing pacemaker with automatic capture detection. We examined whether it is possible to distinguish between effective and ineffective pacemaker stimulus capture by analyzing high pass filtered intracardiac impedance signals that are derived from standard bipolar pacing leads. In one series of 11 patients undergoing replacement or implantation of chronic bipolar pacemakers, four patients during electrophysiology studies, and eight volunteers undergoing invasive electrophysiology trials, we examined intracardiac impedance signals obtained with various stimulation rates and output parameter settings. Additionally we analyzed a series of five patients with implanted pacemakers that can measure and telemeter intracardiac impedance signals. Several evaluation concepts have been analyzed regarding their ability to discriminate between effective and ineffective stimuli. We developed an adequate algorithm that detects capture or loss of capture at different output parameter settings based on intracardiac impedance analysis. The sensitivity is 98.5% and specificity is 91% to loss of capture for the currently investigated algorithm and this can be used to determine the optimal setting of pulse width and amplitude with regard to energy consumption. This concept is currently under realization in the external programmer and in the future an implementation of these algorithms within the pacemaker itself is intended.

A challenge for pacemaker therapists is whether a patient working in an environment with the potential for electromagnetic interference (EMI) can return to their work after a pacemaker has been implanted. Common practice has been to prohibit pacemaker patients from using electric welding machines. Twelve work environments and a new method for monitoring the pacemaker rhythm in the presence of EMI were tested. The new method uses a special memory called the event record found in several Siemens Pacesetter pacemaker models. Surface ECGs with a marking system, intracardiac electrograms, and a digital monitor were used to verify the results with event records. The results from several sources of EMI are reported. Twenty-one in vivo and in vitro tests were performed in the work environments of 12 patients. Event records were useful and accurate both in vivo and in vitro. Electric are welding machines up to 225 A did not affect these pacemakers. Arc welding machines using 1,000 A or more inhibited the in vitro test system within 1 or 2 meters of the weld or power generator. Electric welding machines with high frequency voltage superimposed on the welding current affected the pacemaker when it was within 2 meters of the power unit and 1 meter of the weld. Very large industrial degaussing coils affected pacemakers within 2 meters. The test method using event records was found to be an effective addition to monitoring the pacemaker. These results are specific for the pacemaker models tested. Such testing allows the physician to make a knowledgeable decision regarding return to work for the pacemaker patient in a high EMI environment.

A study was undertaken to evaluate the performance of the Medtronic 4012 polyurethane in-line bipolar pacing electrode. One hundred twenty six patients implanted with the 4012 lead were followed by our clinic with 116 of these leads implanted at our institution. Patients were followed a minimum of every 4 months. Testing included the performance of stimulation thresholds, sensing thresholds, and provocative maneuvers to evaluate for myopotential inhibition testing a minimum of every eight months. There were 12 documented lead failures of the total 126 patients. Further analysis was limited to the ten failures occurring in the 116 leads implanted at our center. All ten failed leads utilized the suture anchoring sleeve. Six of the leads were left cephalic implants, three were right cephalic, and one was right subclavian. Manifestations of failure included: seven oversensing abnormalities, three undersensing, four loss of ventricular capture, one premature end of service, four lead impedance decreases to < 250 omega and some presentations in combination. No leads were explanted for evaluation. The Kaplan-Meier product limit method was used to estimate the time to lead failure. The probability of not experiencing a lead failure within the first 4 years of implant is estimated to be 0.9103 (SE = 0.0338). Pacemaker dependent patients implanted with the 4012 lead should be given special consideration for prophylactic replacement.

A multicenter study was undertaken to determine the failure rate of a specific polyurethane bipolar tined pacing lead, the Medtronic 4012 pacing lead. Six centers in the United States and Canada implanted 1,190 Medtronic 4012 pacing leads. The study was designed to determine the probability and clinical manifestations of lead failure. Only failures compatible with an insulation problem were included. The probability of a 4012 lead failure by Kaplan-Meier analysis was 20.9% at 6 years after implantation. Failures were manifested as sensing abnormalities, failure to capture, early battery depletion, and significant decrease in measured impedance compared with the previous impedance measurements. Of the 95 definite lead failures, 16 (16.8%) were associated with symptoms similar to those experienced before pacemaker placement. The observed failure rate is unacceptable, and strong consideration should be given to replacing the 4012 pacing lead in pacemaker-dependent patients and closely monitoring nondependent patients.

Advances in cardiac pacing continue at an astounding rate, and, occasionally, technologic capabilities are developed almost faster than they can be implemented clinically. The development and implementation of single- and dual-chamber rate-adaptive pacemakers have been the major thrusts in cardiac pacing in recent years. Rate-adaptive pacing will continue to be of primary interest in the future as investigators search for the perfect "sensor" and attempt to develop rate-adaptive pacemakers with multiple sensors. The "smart" pacemaker--that is, an autoprogramming, autodiagnostic device--will also be refined. The ultimate "smart" pacemaker would be capable of automatically adjusting output and sensing factors as well as altering the rate-adaptive variables and even changing the pacing mode in response to variations in the underlying rhythm. Other aspects of cardiac pacing that will be actively investigated include new low-threshold pacing lead designs, refinements of the single-lead pacing system capable of P-synchronous pacing, and diagnostic information that can be derived from sensors used for rate-adaptive pacing.