Permanent Cardiac Pacing with Electrodes of a New Type of Fixation in the Endocardium

To improve electrode construction the following main problems have been considered: (1) reliable initial fixing in the endocardium, and (2) reducing the area of contact surface and improving threshold values. In this article we have described three original electrodes: 1) an endocardial electrode with a multi-edged tip (contact area 28 mm2), which gives high electric field strength and low thresholds; 2) a spreading tip electrode, which was created on the basis of morphological data. The tissues grow into the spread spaces of this tip and ensure better stability (contact area 17.8 mm2); and 3) a double-screw-in electrode which differs from the other corkscrew types. The contact end (surface area--10.4 mm2) consists of two sickle-shaped hooks. The sickle handle is 0.7 mm in length which prevents further hook penetration in the wall of the heart. It was found that a multi-edged electrode and electrodes supplied with a fixation device are, in terms of energy consumption, more effective compared to electrodes with spherical or cylindrical tips of the same area of contact surface. The double-screw-in endocardial electrode has useful features: reliable fixation and a small contact surface area and, therefore, a low threshold value. Thirty-five double-screw-in electrodes were inserted into an atrial position and 28 into a ventricular position. We have not observed any displacement of such electrodes during the past two years.     

Acute and Long-Term Ventricular Stimulation Thresholds with a New, Iridium Oxide-Coated Electrode

Efforts have been made to design electrodes that significantly reduce not only the acute and chronic stimulation thresholds, but also attenuate the early peaking phenomenon and polarization. At two voltage levels (2.7 V and 5.4 V, respectively), we evaluated the right ventricular stimulation thresholds obtained with a new, iridium oxide-coated electrode in ten patients who received a VVI pacemaker. Measurements were mode at implant and at multiple intervals for 1 year. Pulse width stimulation thresholds at implant were as follow: 0.04 ± 0.008 msec at 2.7 V, 0.03 ± 0.004 msec at 5.4 V; values at 2 weeks were 0.14 ± 0.06 msec at 2.7 V, 0.07 ± 0.025 msec at 5.4 V; values at 3 months were 0.09 ± 0.03 msec at 2.7 V, 0.05 ± 0.01 msec at 5.4 V; values at 1 year were 0.08 ± 0.02 msec at 2.7 V, 0.04 ± 0.01 msec at 5.4 V, The maximal increase of 0.11 ± 0.05 msec occurred at 2.7 V, 2 weeks after implant. Our results indicate that this new electrode provides low acute and long-term stimulation thresholds, as well as an attenuated early peaking phenomenon, being able to stimulate safely at 2.7 V even early after implant.     

The Use of Balloon-Tipped Electrodes for Permanent Cardiac Pacing

A new balloon-tipped ventricular endocardial electrode for permanent artificial cardiac pacing is described. Following transvenous insertion of the electrode to the right ventricular apex, the distal balloon is inflated with contrast material in order to wedge the electrode tip between or beneath trabeculae and prevent displacement. fifty-nine electrodes were implanted, including a second generation type incorporating a wedge tip as well as the balloon. The incidence of displacement was 17% with 10% of cases being early, and 7% late. Early in the series, 50% Urografin was used to inflate the balloon and this resulted in premature deflation and early electrode displacement in two of the nine patients. When the concentration of Urografin was reduced, the balloon remained inflated for a longer period and the incidence of early displacement was reduced to 8%. However, there was still a late displacement of 8%. Only one wedge-tipped balloon electrode displaced. This electrode had a faulty sealing mechanism and the balloon could not be adequately inflated. There was a 3% incidence of early and a 3% incidence of late threshold problems with the electrode. However, name of the wedge-tipped balloon electrodes exhibited this problem. It was concluded that this new electrode did not fulfill its objectives. The total electrode failure rate, including displacements and episodes of high threshold was approximately 24%.     

Stability of Permanent Transvenous Dual-Chamber Pacing Electrodes During Cardiopulmonary Resuscitation

For long-term dual-chamber permanent pacing, atrial and ventricular lead stability is essential. In our overall experience with such pacing systems, four patients suffered cardiac arrest at a time distant from their pacemaker implantation. Since all four patients received prolonged closed chest cardiopulmonary resuscitation, we analyzed these events to determine whether dual-chamber endocardial electrodes would remain stable in such traumatic conditions. Reliable atrial and ventricular lead position was confirmed at autopsy in the three patients whose resuscitation attempts were unsuccessful and, in the fourth patient, by continued normal lead position and pacing function post-resuscitation. The keys to this stability include the use of tined atrial and ventricular endocardial leads and specific maneuvers at the time of implantation to verify fixation. Long-term stability of presently available endocardial leads in dual-chamber pacing systems can thus be anticipated.     

Long-Term Performance of Endocardial Leads with Steroid-Eluting Electrodes

During a three-year period, 48 steroid-eluting leads (Medtronic* 4003 and 4503] have been implanted in 39 patients. 23 were implanted in the atrium and 25 in the ventricle. 36 patients with 45 leads have been observed for more than 12 months. Stimulation thresholds have been followed using pulse generators with variable output (vario): 12 atrial and 11 ventricular leads, 4 atrial leads and 11 ventricular leads have been followed using pulse generators with variable pulse-width (auto-threshold], P-waves have been followed using telemetry or sensitivity programming (23 atrial leads). R-waves have been followed using telemetry in 11 ventricular leads. Mean stimulation thresholds after 2 years are 0.7 V ± 0.2 in the atrium and 0.8 V ± 0.3 in the ventricle. P-waves after 2 years are of magnitudes allowing a sensitivity setting of 2.5 mV in 12 cases and of 1.5 mV in 2 cases; R-waves have in all cases been high enough to permit lowest programmable sensitivity setting. During the observation time, two patients have died from nonpacing-related causes. The results obtained from this investigation document low stimulation thresholds and good sensing levels in both ventricle and atrium using the steroid-eluting electrode with no significant changes after 6 weeks postimplant.     

Assessment of Long-Term Stability of Chronic Ventricular Pacing Thresholds in Steroid-Eluting Electrodes

Sixteen patients with Medtronic 4003 steroid-eluting electrodes implanted in the ventricular position were followed over 5 years. In each patient a special type of Medtronic 2443 pacemaker was implanted to allow programming of output at 1.35 V. Chronic threshold values in these patients measured at an output of 1,35 V were stable over the first 18 months of follow-up. Mean values were: 0.06 ± 0.03 msec at 6 months and 0.08 ± 0.02 msec at 18 months; these did not differ from each other significantly. However, during the period from 18 to 36 months postimplantation, a significant increase in mean pacing threshold was observed: 0.08 ± 0.02 msec at 18 months postimplantation versus 0.14 ± 0.05 msec at 36 months (P < 0.01), After 36 months, the chronic pacing threshold remained stable until the end of the 5-year follow-up period. Further long-term study of chronic threshold behavior of steroid-eluting electrodes measured at low amplitudes is warranted.     

Long-Term Threshold Stability with Porous Tip Electrodes

Experience with 163 unipolar tined porous endocardial electrodes is reported. One patient required repositioning of the electrode because of exit block. There were no other complications in the entire series of patients. All of the patients had low chronic stimulation thresholds. The mean pulse width 24 hours after implantation was 0.0534 ± 0.0128 ms. Seventy-four patients were restudied six months after implantation. The mean pulse width threshold was then 0.07432 ± 0.0775 ms. Fifty-four patients were evaluated one year after lead implantation. The mean pulse width threshold was then 0.0611 ± 0.0230 ms. The pulse generator was reprogrammed to a lower pulse width in all of the patients. This permitted a substantial prolongation of the pulse generator life. The cost effectiveness of the pulse generator was also greatly improved by pacing with reduced pulse widths. In an additional 16 patients, the voltage amplitude was reduced from 5.0 volts to 2.5 volts. This permitted an even greater increase in the pulse generator longevity.     

Cardiac Electrodes and Electrograms: Some New Observations and Concerns

Electrode studies have been performed with dead animal tissue and a variety of other materials immersed in saline solution and compared with studies in the canine heart (live and arrested) in an attempt to delineate both normal and anomalous signals sensed by pacemaker electrodes or obtained during diagnostic electrogram recording of cardiac activity. The data from these studies could be useful for defining the origin of artifacts and a variety of other phenomenon such as "fractured" QRS complexes, acute ST segment elevations, His bundle oscillatory signatures, and unexplained potentials synchronously associated with cardiac events. The studies verify that artifacts can be generated in an electrolyte medium by rubbing electrodes against insulators or biologic materials and by inducing motion between common pole materials of an active electrode system. The studies suggest that some of the grasping electrodes in current clinical use may be subject to self-generating artifacts associated with cardiac-induced frictional motion between the constituent materials employed in the electrode design.     

Experience and Implantation Techniques with a New Single-Pass Lead VDD Pacing System

Thirty-six patients were implanted with a single-lead atrial-synchronous ventricular pacing (VDD) system at our center in the first and second phases of a clinical trial between October 1987 and December 1989. The clinical system comprised a pulse generator in conjunction with a pacing lead incorporating two diagonal atrial bipolar (DAB) electrodes designed to lie in the mid-to upper-right atrium and a distal tip electrode for ventricular pacing and sensing. Twenty five of the patients had complete heart block, ten had second-degree block, and one had AV nodal block. A modified Bruce protocol limiting treadmill speed to 1.7 miles per hour was used to establish sinus node competency as evidenced by sustained sinus rate increase in a more-or-less linear fashion. The mean acute P wave amplitude measured at implant was 1.66 mV +/- 1.04 SD; the mean P wave amplitude (minimum and maximum, both sitting and supine) for all patients at all follow-up (N = 420) was 1.54 mV +/- 0.9 SD. The follow-up interval for all patients ranged from a minimum of 13 days and a maximum of 762 days, with a mean of 261 +/- 206 days as of December 1, 1989. Four dislodgments of the ventricular electrode occurred with the more pliable of two passive fixation mechanisms used on the lead; atrial sensing remained intact at all times with both fixation systems. Changes in atrial sensing threshold were quite frequent during the early follow-up visits due to electrode movement in the right atrium; however, adequate ventricular tracking of the atrial rate was achieved in all cases once the threshold values were established initially, even though several patients required atrial sensing of 0.2 mV at some of the follow-up visits. Two patients presented with pacemaker-mediated tachycardia associated with retrograde conduction, which was resolved with reprogramming; they are presently maintaining atrial synchrony in the VDD mode. Successful single-lead VDD pacing with consistent P wave sensing has been achieved with this atrial rate responsive system.     

Clinical Experience with Steroid-Eluting Unipolar Electrodes

In continuing search of low chronic threshold leads, a new concept of electrode design which is capable of delivering corticosteroids at the myocardial tissue interface has been made available by Medtronic. Twenty-three patients, 17 females and 6 males, were either implanted with 4003 (n = 21) or 5023 (n - 2) steroid-eluting electrodes in the ventricular chamber. Pacing modes utilized were WIM (n = 13) or DDD (n = 10). Pulse generators used were Medtronic (7005. 8317, 8329) Pacesetter (285) and Intermedics (283). Thresholds at the time of implantation at 0.50 msec pulse width were 0.40 ± 0.02 volts at 0.66 ± 0.05 milliamps. Resistance and R wave measured were 565.43 ± 22.07 ohms and 9.24 ± 1.06 mv, respectively. Chronic thresholds were checked on routine follow-up visits by either decreasing pulse width and for pulse amplitude. Data is being reported between 1 and 88 (23.22 ± 4.35) weeks. Pulse width threshold at 2.5 volts were 0.10 msec (n = n) and 0.05 msec or lower (n = 12). At 5.0 volts no loss of capture was seen at 0.05 msec (n = 22) except in one patient at 0.10 msec. Pulse width thresholds in the first 24 weeks were lower than 0.20 msec at 2.5 volts (n = 15) and less than 0.70 msec, at 0.8 volts (n = 6). No loss of sensing was seen by electrocardiographic analysis at the time of threshold checks with the pulse generator at standard setting of the R wave. Thus, in this initial report, the steroid-eluting electrodes have demonstrated very low thresholds both in the early and chronic follow-up phase. Demonstration of consistently low thresholds, avoiding initial peaking, will permit routine low output setting without compromising safety and thus prolong the life of the pulse generators.     

Comparison of a Porous-Surfaced with a Totally Porous Ventricular Endocardial Pacing Electrode

Porous endocardial ventricular electrodes, re-cent innovations in cardiac pacing technology, have been shown to perform in a su-perior manner compared to conventional solid electrodes with respect to such parameters as stimulation threshold, sensed R-wave amplilude, and source im-pedance, This experimental study compared the electrophysiological performance of a porous-surfaced and a totally porous electrode, two fundamental design vari-ations of the porous eJectrode concept which are in current clinical use. Six porous-surfaced (1 mm length, 2.3 mm diameter, 8.8 mm² outer surface area, pores < 25 μn) and six totally porous (1.3 mm length, 2.0 mm diameter, 7,5 mm- outer surface area, pores 100 to 150 μm) flanged ventricular endocardial eleclrodes were implanted into the right ventricular apex of 12 dogs. Stimulation threshoids under constant current and constanl voltage conditions at pulse durations of 0.1, 0.25, 0.5, 0.75, 1.0, 1.5, and 2.0 milliseconds, sensed peak-to-peak R-wave amplitudes, and source impedance ivere measured at implant and at l, 4, 8, 12,16, 24, and 30 weeks (explant) thereafter. Analyses of voriance on the data for the strength-durolion curves at expiant and the threshold-time curves at l ms pulse duration indicated highly significant differ-ences between the performance of the two types of electrodes, the porous-surfaced electrodes displaying average Stimulation threshoids approximateiy 30% lower than the totally porous electrodes. Student's t tests indicated the magnitude of the sensed R-wave to be maintained over the 30 week period for the porous-surfaced electrodes but to decrease by about 20% for the totally porous electrodes. In addition, the chronic source impedance of the porous-surfaced electrodes was significtmtly Jess (about 257%) than that of the totally porous electrodes. These differences indi-cate better overall electrophysiological performance for the porous-surfaced electrodes as compared with the totally porous electrodes. Both types of electrodes, however, operate well within the limits of highly acceptable function and therefore rep-resent attractive designs for clinical use in endocardial pacing.     

A Comparison of Platinized Grooved Electrode Performance with Ring-Tip Electrodes

One of the determinants of the capture threshold of an endocardial pacing lead is the configuration of the electrode tip. To evaluate whether micro- and macroporous electrodes have better initial and chronic thresholds than nonporous electrodes, acute and chronic capture thresholds, stimulation impedance and sensing thresholds were determined in 22 patients in whom a ventricular ring-tip electrode and a unipolar, dual chamber pacemaker with bidirectional telemetry had been implanted. These values were compared to those obtained from 25 patients receiving an electrode constructed with a platinized groove surface at the time of implant of an identical pulse generator. The ventricular capture threshold at implant was 0.7 V +/- 0.3 at 0.6 msec pulse width for both groups. The capture threshold was significantly greater in the ring tip electrode group at follow-up periods of 1 month (1.1 V +/- 0.5 vs 1.6 V +/- 0.6, P less than 0.008), 4 months (1.0 V +/- 0.2 vs 1.7 V +/- 0.8, P less than 0.002), and 10 months (1.2 V +/- 0.4 vs 1.7 V +/- 0.5, P less than 0.04) following implantation. The stimulation impedance at the time of implantation was lower in the ring-tip electrode group (530 ohms vs 603 ohms, P less than 0.03), but thereafter no significant difference was seen between the two groups. The acute and chronic sensing thresholds were similar in both groups. While the microporous electrode had significantly lower chronic capture thresholds, the magnitude of this difference is small, and probably clinically inconsequential.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical Experience with New Leads

Recent developments in cardiac pacemaker electrodes have resulted in significant benefits to the group of pacemaker patients as a whole. The results of analysis of 2,818 chronic pacemaker electrodes are presented. These electrodes are divided into major categories according to their particularities: platinum iridium, elgiloy, carbon-tip, anodized platinum and granulated iridium-platinum. All leads were in the ventricular position. The results of acute and chronic threshold measurements reveal that carbon-tipped electrodes appear to have the most favorable overall characteristics. This will have a major influence on long-term pacing practices.     

Comparison of Pacing Electrodes of Different Shape and Material—Recommendations

Plusieurs suggestions pour la comparaison des différenles électrodes de stimulation sont énumérées. Dans Ja majorité des rapports cités, ces comparaisons n'atteignent pas leur but, parce que les paramètres de mesure utilisés ne sont pas constants. Un calendrier pour les mesures de seuil aigu et chronique est proposé rheobase et chronaxie est aussi expliqué. EnFin le rôle de la polarisation ďélectrode est disculé.
Recommendations for comparing different pacing electrodes to one another are presented. In most reported studies, such comparisons fall short of the intended gool because they are made with eiectrode parameters that are not constant. The suggestions presented include timetables for acute and chronic threshold measurements, conditions for measuring lead impedance, and the relationship between rheobase and chronaxie. In addition, the effects of polarization of the electrodes are discussed.     

Successful Percutaneous Extraction of a Chronic Left Ventricular Pacing Lead

This report describes a patient with a chronic endocardial left ventricular pacing lead. To avoid the risk of future embolization, it was felt that the lead should be removed and right ventricular pacing established. The lead was carefully evaluated by transesophageal echocardiography to exclude adherent thrombus. Successful percutaneous lead extraction was accomplished without sequelae, thus avoiding the morbidity of a thoracotomy.     

Permanent Cardiac Pacing After Open-heart Surgery: Acquired Heart Disease

Retrospective review of 5,942 patients who underwent open-heart surgery for acquired heart disease revealed that 123 patients (2.1%) required permanent cardiac pacing postoperatively; 4.6% of these underwent predominantly valvular surgery and 0.6% had coronary bypass. The most important factors appeared to be: 1) preoperative evidence of a conduction disorder; 2) advanced patient age; 3) dense calcium in the aortic annulus; 4) valvular surgery and, especially, tricuspid valve surgery; and 5) poor myocardial protection. Postoperative permanent pacing had a considerable impact on patient morbidity from maintenance operations; most complications were lead-related problems.     

Chronic Right Ventricular Pacing and Cardiac Performance:

Cardiac stimulation from right ventricular apical or free-wall lead positions alters inter- and intraventricular impulse conduction and distorts biventricular contractility. This may contribute to eventual cellular remodeling and the development of histopathological changes which, over time, adversely affect left ventricular systolic and diastolic functions. This concept has especially important implications when pacemaker therapy is initiation in young patients. Recent studies demonstrating physiological benefits of right ventricular septal, outflow, or bundle of His pacing, in deference to the apical implant site, have gained interest to potentially prevent dysfunction and improve paced myocardial contractility. Pacing initiated in children can be expected to have more far-reaching consequences than pacing initiated in the elderly. Unfortunately, there have been limited clinical pediatric studies that evaluate precise site-specific lead locations. This current report presents a review of pacemaker applications in children, both with and without structural congenital heart defects, including the earliest applications in which patient survival was the prime concern, to more recent studies attempting to optimize physiological and histological parameters associated with pacemaker induced contractility. The past decade has seen direct evidence that right ventricular apical pacing in children contributes to adverse histological remodeling and eventual contractile dysfunction. More recent studies demonstrate that selective site pacing can be effectively applied to all children with and without structural congenital defects and shows promise in the prevention of previously documented adverse remodeling and deterioration of systemic ventricular contractility. (PACE 2004; 27[Pt. II]:844–849)     

Evaluation of an Ultrasonically Guided Venepuncture Technique for the Placement of Permanent Pacing Electrodes

We have evaluated a method of puncturing the subclavian vein in its extrathoracic portion using on ultrasound guidance system. Seventy consecutive patients requiring permanent pacemakers were included in the study. The method was successful in 56 (80%) cases (23 dual chamber systems) and unsuitable or unsuccessful in 14 (20%) cases (2 dual chamber systems). The time taken to achieve a successful cannulation of the vein was similar to that taken with conventional subclavian Venepuncture (average time taken for each Venepuncture WAS 31 seconds, range 5–130 seconds). There was a significant "learning curve" in that nearly all of the unsuccessful cases were in the first half of the series. There were no major complications. Computerized Tomography (CT) confirms that the point of entry into the subclavian vein using this technique lies outside the thoracic cavity, thereby minimizing the risk of pneumothorax. This approach to the subclavian vein is an easy technique to learn, with few immediate complications and there maybe less chance of lead fracture due to subclavian crush in the longer term.     

The Value of Redundancy in Chronic Bipolar Pacemaker Electrode Systems

Bipolar pacing systems, because of the presence of two intracardiac electrodes, provide lead redundancy. This allows conversion of bipolar to unipolar pacing or the reversal of lead polarity. During a 3-year period, this redundancy was utilized in 34 (13.7%) of 248 patients with chronic bipolar lead systems during follow-up pacemaker surgery. Of the 34 patients, elective pulse generator change was the most frequent indication for surgery (23 patients) and in this group redundancy was used most often to select the lead configuration with the highest R-wave amplitude and lowest stimulation threshold, or to solve the problem of weld defects of the connector pins or frayed insulation. The remaining 11 patients underwent surgery for pacemaker system malfunction and in this group redundancy was used to avoid the need for lead repositioning or placement of a new catheter system. Lead redundancy in those patients in whom bipolar pacing has been selected provides flexibility at the time of additional pacemaker surgery, and its use may obviate the need for a change in catheter system when stimulation thresholds are excessive, wire fraction is irreparable, or bipolar sensing signals are inadequate.