Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead

GRADAUS, R., et al. : Implantation of a Dual Chamber Pacing and Sensing Single Pass Defibrillation Lead. Dual-chamber ICDs are increasingly used to avoid inappropriate shocks due to supraventricular tachycardias. Additionally, many ICD patients will probably benefit from dual chamber pacing. The purpose of this pilot study was to evaluate the intraoperative performance and short-term follow-up of an innovative single pass right ventricular defibrillation lead capable of bipolar sensing and pacing in the right atrium and ventricle. Implantation of this single pass right ventricular defibrillation lead was successful in all 13 patients (  age 63 ± 8 years  ; LVEF  0.44 ± 0.16  ; New York Heart Association [NYHA]  2.4 ± 0.4  , previous open heart surgery in all patients). The operation time was  79 ± 29  minutes, the fluoroscopy time  4.7 ± 3.1  minutes. No perioperative complications occurred. The intraoperative atrial sensing was  1.7 ± 0.5 mV  , the atrial pacing threshold product was  0.20 ± 0.14 V/ms  (  range 0.03–0.50 V/ms  ). The defibrillation threshold was  8.8 ± 2.7 J  . At prehospital discharge and at 1-month and 3-month follow-up, atrial sensing was  1.9 ± 0.9, 2.1 ± 0.5, and 2.7 ± 0.6 mV  , respectively, (  P = NS, P < 0.05, P < 0.05  to implant, respectively), the mean atrial threshold product  0.79, 1.65, and 1.29 V/ms  , respectively. In two patients, an intermittent exit block occurred in different body postures. All spontaneous and induced ventricular arrhythmias were detected and terminated appropriately. Thus, in a highly selected patient group, atrial and ventricular sensing and pacing with a single lead is possible under consideration of an atrial pacing dysfunction in 17% of patients.     

Multicenter Experiences with a Single Lead Electrode for Dual Chamber ICD Systems

Monitoring of atrial signals improves the accuracy in identifying supraventricular tachyarrhythmias to prevent inappropriate therapies in patients with implantable ICDs. Since difficulties due to the additional atrial lead were found in dual chamber ICD systems with two leads, the authors designed a single pass VDD lead for use with dual chamber ICDs. After a successful animal study, the prototype VDD lead (single coil defibrillation lead with two additional fractally coated rings for bipolar sensing in the atrium) was temporarily used in 30 patients during a German multicenter study. Atrial and ventricular signals were recorded during sinus rhythm (SR), atrial flutter, AF, and VT or VF. The implantation of the lead was successful in 27 of 30 patients. Mean atrial pacing threshold was 2.5 +/- 0.9 V/0.5 ms, mean atrial impedance was 213 +/- 31 ohms. Atrial amplitudes were greater during SR (2.7 +/- 1.6 mV) than during atrial flutter (1.46 +/- 0.3 mV, P < 0.05) or AF (0.93 +/- 0.37 mV, P < 0.01). During VF atrial "sinus" signals had significantly (P < 0.01) lower amplitudes (1.4 +/- 0.52 mV) than during SR. The mean ventricular sensing was 13.3 +/- 7.9 mV and mean ventricular impedance was 577 +/- 64 ohms. Defibrillation was successful with a 20-J shock in all patients. In addition, 99.6% of P waves could be detected in SR and 84.4% of flutter waves during atrial flutter. During AF, 56.6% of atrial signals could be detected without modification of the signal amplifier. In conclusion, a new designed VDD dual chamber lead provides stable detection of atrial and ventricular signals during SR and atrial flutter. Reliable detection of atrial signals is possible without modification of the ICD amplifier.     

Single Pass Lead VDD Pacing in Children and Adolescents

Implantation of permanent pacemakers in children and adolescents is possible but usually is limited to single chamber generators. The natural growth of these patients may require physiological pacing, but until recently two leads were required for this type of pacing. The single pass lead VDD pacing mode makes posible physiological pacing by using only one lead, for both atrial sensing and ventricular sensing and pacing. The feasibility of VDD pacing using endocardial lead was evaluated in 16 children and adolescents with congenital or postsurgical atrioventricular block. Their mean age was 7.9 ± 4.9 years (range 1-16 years) and the smallest patient's weight was 8.2 kg. In all the patients, a single pass pacing lead with atrial sensing rings and bipolar ventricular pacing and sensing capability was implanted through the left or right subclavian vein. The pacemaker generator was implanted in a rectopectoral position. The mean atrial electrogram during the implantation was 4.2 ± 2.1 mV and 2.6 ± 1.9 mV after a mean of 1 week. The ventricular pacing threshold was 0.5 ± 0.2 V; the ventricular pacing impedance was 560 ± 95 Ω and the ventricular electrogram amplitude was 9.9 ± 2.1 mV. This is a first report to demonstrate the feasibility of atrial synchronous ventricular endocardial pacing using a single pass lead in a relatively large group of children and adolescents.     

Three-year follow-up of atrial sensing efficacy in children and adults with a single lead VDD pacing system

The purpose of this study was to evaluate the efficacy of atrial sensing in children with a single pass lead VDD pacing system and to compare it with the efficacy of atrial sensing in adult patients with the same pacing system. Although the feasibility of single pass lead VDD pacing system implantation in children was recently demonstrated, the efficacy of atrial sensing remains unclear. In addition, the effect of accelerated growth of children on the systems' efficacy has not been addressed. Atrial sensing followed by ventricular sensing and atrial sensing followed by ventricular pacing was prospectively evaluated in 13 children (age 0.5-15 years) and 24 adult patients (age 19-74 years). All had the same endocardial pacing system using a single pass lead. The children and adults had effective atrial sensing at a success rate of 94.00 +/- 9.687% and 96.04 +/- 4.64%, respectively, during mean follow-up of 3.5 years. The atrial electrogram amplitude was similar in both groups, 1.8 +/- 1.5 mV in children and 1.8 +/- 1.1 mV in adults. The adult patients more frequently exhibited ventricular sensing following atrial sensing. The ventricular pacing threshold and impedance were stable in both groups. When necessary, in children, the atrial sensing was corrected by adjusting the pacemaker's lower rate programming. Highly effective atrial sensing was demonstrated in children and adult patients with a single pass lead VDD pacing system. During a mean follow-up of 3.5 years, not only was the atrial electrogram amplitude stable, but the clinically relevant atrial sensing was highly effective, justifying endocardial pacing with single pass lead VDD pacing in children and adults with preserved sinus node function.     

Far-field QRS complex sensing: prevalence and timing with bipolar atrial leads

Sensing of far-field QRS complex through the atrial pacemaker lead may cause a number of pacemaker function disturbances, most of which are rarely seen with modern pulse generators. However, certain pulse generator algorithms will still be jeopardized by far-field QRS complex sensing. Intracardiac electrograms with markers were obtained by telemetry in 30 patients following implantation of a permanent bipolar atrial lead and a DDDR pulse generator. The occurrence and timing of far-field QRS complex sensing was studied at different atrial amplifier sensitivity settings. With paced ventricular complexes, QRS sensing was documented in all 30 cases at the maximum atrial sensitivity (0.1 mV). The median QRS complex sensing threshold was 0.3 mV, and the sensing window at high atrial sensitivities was 67-202 ms following the ventricular pacing impulse. In one case, QRS complex sensing was seen up to an atrial sensitivity of 1.5 mV. In 12 of 13 patients with 1:1 AV conduction, atrial sensing of spontaneously conducted ventricular complexes was seen (median sensing threshold 0.2 mV; the sensing window was -23 to 114 ms relative to the ventricular amplifier sensing event). Far-field QRS complex sensing was also found in all 12 patients in whom ventricular fusion complexes were obtained (median sensing threshold 0.2 mV; the window of sensing was 64-187 ms after the ventricular pacing impulse). Constant or intermittent QRS complex sensing via the atrial bipolar lead was thus universally demonstrable. It occurred in only a minority (20%) of patients at a sensitivity of 0.5 mV or less. Knowledge regarding the timing of the oversensing as related to the atrial sensitivity setting may aid in the design of algorithms of future pacemakers and cardioverter defibrillators.     

Performance of temporary epicardial stainless steel wire electrodes used to treat atrial fibrillation: a study in patients following open heart surgery

AF is the most common arrhythmia following open heart surgery. Transthoracic cardioversion is used when pharmacological treatment fails to restore SR, or is ineffective in controlling ventricular response rate. We report on the performance of temporary atrial defibrillation wire electrodes implanted on the epicardium of patients undergoing open heart surgery. Epicardial stainless steel wire electrodes for both pacing/sensing and atrial defibrillation were placed at the left and right atrium during open heart surgery in 100 consecutive patients (age 65 +/- 9 years; male/female 77/23). Electrophysiological studies performed postoperatively revealed a test shock (0.3 J) impedance of 96 +/- 12 omega (monophasic) and 97 +/- 13 omega (biphasic). AF was induced by burst stimulation in 84 patients. All patients were successfully converted to SR. The mean energy of successful shocks was 3.1 +/- 1.9 J. Atrial pacing and sensing were accomplished in all patients. Pacing threshold was 1.9 +/- 1.7 V (0.5 ms) in the left atrium and 2.1 +/- 2 V in the right atrium. P wave sensing was 2.5 +/- 1.6 mV in the left atrium and 2.3 +/- 1.4 mV in the right atrium. No complications were observed with shock application, nor with lead extraction. Atrial defibrillation using temporary epicardial wire electrodes can be performed successfully and safely in patients following cardiac operations. The shock energy required to restore SR is low. Electrical cardioversion in the absence of anesthesia should be feasible.     

Chronic experiences with a single lead dual chamber implantable cardioverter defibrillator system

Monitoring of atrial rhythm in patients implanted with ICDs may improve accuracy in identifying supraventricular arrhythmias and, therefore, prevent inappropriate therapies. Since difficulties were found in dual chamber ICDs with separate leads, a new designed single lead dual chamber ICD system was tested. Twenty-five patients implanted with a Deikos A+ (single coil defibrillation lead with two atrial sensing rings combined with a dual chamber ICD with a high amplifying atrial channel) were tested. Atrial and ventricular signals were analyzed during sinus rhythm (SR) and sinus tachycardias (STs), atrial flutter and AF, and VT or VF. Follow-ups were performed after 1, 3, 6, 9, and 12 months after implantation. Analysis of EGM amplitudes of stored episodes revealed that atrial signals during atrial flutter (2.1 +/- 0.51 mV) were comparable to those of ST (2.2 +/- 0.5 mV). Atrial amplitudes during AF were significantly lower (0.81 +/- 0.5 mV, P<0.01). During VF atrial "sinus" signals (2 +/- 0.8 mV) were stable. Ventricular parameters did not differ from a standard ICD lead; defibrillation threshold was 11.4 +/- 4.5 J (16 patients). During intraoperative and prehospital discharge measurements, 97.1% of SR-P waves and 99.2% of atrial flutter waves were detected correctly. In AF 91.11% of atrial signals were detected. Analysis of 505 stored episodes showed that 96.8% of ST and 100% of atrial flutter and 100% of AF episodes have been classified correctly and no underdetection of VT/VF was found. The first experiences with the new VDD-ICD system show an increase of the specificity to detect ventricular tachycardias to a level comparable to dual chamber ICDs with two leads. The reliability of this system has to be proven in a prospective randomized study.     

A Randomized Controlled Clinical Trial Comparing Ventricular Fibrillation Detection Time Between Two Transvenous Defibrillator Models

The Ventak AV is an implantable cardioverter defibrillator with dual chamber pacing capability. Features include detection and treatment of ventricular arrhythmias, detection of atrial arrhythmias, as well as dual chamber pacing. The objective of the investigation was to verify the efficacy of the Ventak AV in detecting ventricular fibrillation in the presence of dual chamber pacing. Thirty-three patients, who were to receive an implantable defibrillator were randomized (1:1) in a paired comparison study to the Ventak AV (study device) and the Ventak Mini (control) during defibrillation threshold testing. In order to create a "worst case scenario" for sensing of ventricular fibrillation, pacing was performed at high lower rate limit values (Ventak AV DDD pacing at 150/min, Ventak Mini at VVI 100/min). Ventricularfibrillation was induced and the randomized device was allowed to detect and treat the arrhythmia. This test was repeated for each patient using the alternate device in a randomized order, such that all patients were tested with both devices. The mean ventricular fibrillation detection time for the Ventak AV was 2.0+/-0.11 seconds and for the control device the detection time was 1.8+/-0.11 seconds (P = 0.26). Appropriate tachyarrhythmia therapy decision was documented in all episodes for both devices. The study patient population demonstrated equivalent ventricular fibrillation detection time between the Ventak AV and the Ventak Mini. The Ventak AV demonstrated effectiveness in detecting ventricular fibrillation in the presence of high rate dual chamber pacing.     

Right ventricular outflow tract placement of defibrillation leads: five year experience

Over a 5-year period, 112 patients (89 male/23 female, mean age 65 years) underwent right ventricular outflow tract (RVOT) placement of permanent active-fixation transvenous pacing/defibrillating leads. At implantation, the pacing threshold was 0.6 +/- 0.3 V at 0.5 ms pulse duration and R wave amplitude was 10.9 +/- 4.9 mV. The defibrillation threshold (DFT) of right-sided implants was 17.7 +/- 3.4 J while that of left-sided implants was 16.1 +/- 3.3 J. Patients were followed at 1 and 3 month postimplant and at six-month intervals thereafter. At mean follow-up of 22.5 +/- 17.5 months (range 1-47 months) there were no lead dislodgments, unsuccessful shock therapies, or failure to sense or pace for bradycardia or tachycardia. Death was not sudden in the 17 patients who died. We conclude that RVOT pacing-defibrillation lead implantation is safe, efficacious, and potentially attractive because preliminary evidence suggests that it may not be associated with the adverse hemodynamic effects of pacing at the right ventricular apex.     

Five-Year Follow-Up of a Bipolar Steroid-Eluting Ventricular Pacing Lead

Steroid-eluting pacing leads are known to attenuate the threshold peaking early after implantation. Long-term performance, however, is not yet settled. The lead design tested in this prospective study combines a 5.8-mm2 tip of microporous platinum-iridium with elution of 1.0 mg of dexamethasone sodium phosphate and tines for passive fixation (model 5024, Medtronic Inc.). In 50 patients (mean age 69 +/- 10 years), the electrode was implanted in the right ventricular apex. Follow-up was performed on days 0, 2, 5, 10, 28, 90, 180 and every 6 months thereafter for 5-years postimplant. At each visit, pacing thresholds were determined as pulse duration (ms) at 1.0 V and as the minimum charge (microC) delivered for capture. Lead impedance (omega) was telemetered at 2.5 V-0.50 ms, and sensing thresholds (mV) were measured in triplicate using the automatic sensing threshold algorithm of the pacemaker implanted (model 294-03, Intermedics Inc.). On the day of implantation, mean values were 0.10 +/- 0.03 ms, 0.12 +/- 0.03 microC, 758 +/- 131 omega, and 13.1 +/- 1.8 mV, respectively. Beyond 1-year postimplant, pacing thresholds did not vary significantly. Sensing thresholds and lead impedance values were stable during long-term follow-up. Five years after implantation, mean values were 0.23 +/- 0.11 ms, 0.24 +/- 0.07 microC, 670 +/- 139 omega, and 11.6 +/- 3.1 mV for pulse width and charge threshold, lead impedance, and sensing threshold, respectively, and all leads captured at 1.0 V with the longest pulse duration available (1.50 ms). It is concluded that the bipolar steroid-eluting tined ventricular lead showed stable stimulation thresholds, lead impedance values, and sensing thresholds for 5 years after implantation.     

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.     

Experience with a Low Profile Bipolar, Active Fixation Pacing Lead in Pediatric Patients

Continued miniaturization of permanent pacing systems has promoted use of this technology in younger and smaller pediatric patients. Intermedics ThinLine 438-10 active fixation pacing leads (4.5 Fr lead body) were implanted in 26 patients (17 males/9 females; 9.9 +/- 6.9 years). Twenty of 26 patients received dual chamber systems, 6 of 26 patients single lead systems. Each patient has been followed 3 months. Pacemaker analysis at implant and 6 months later evaluated pulse width thresholds at 2.5 V (atrial 0.07 +/- 0.02 vs 0.13 +/- 0.02 ms [P = 0.01]; ventricular 0.08 +/- 0.04 ms vs 0.20 +/- 0.04 ms [P = 0.01]); sensing thresholds (atrial 4.1 +/- 0.41 mV vs 4.0 +/- 4.2 mV [P = NS]; ventricular 9.7 +/- 0.72 vs 9.3 +/- 0.94 mV [P = NS]); and impedance (atrial 345 +/- 12 vs 370 +/- 120 O [P = 0.04]; ventricular 412 +/- 17 vs 458 +/- 190 O [P < 0.01]). One volt lead failed with exit block at approximately 6 weeks. The youngest (9 months to 5 years) and smallest (6.5-18.0 kg) ten patients have each shown by venography to have at least mild venous stenosis at the lead(s) insertion site; five patients demonstrated collateral formation around asymptomatic obstruction, with no thrombus formation. The Intermedics 438-10 ThinLine pacing lead has demonstrated good and stable early postimplant electrical parameters. Angiographic evaluation in our smaller patients has shown evidence for asymptomatic venous obstruction.     

Single-Lead VDD Pacing System

A single pass ventricular lead with a dual chamber electrode system, designed for VDD pacing, was implanted in 17 patients (11 men, 6 women, aged 53 to 86 years, mean 74) for symptomatic bradycardia due to second-or third-degree AV block and normal sinus node function. Bipolar atrial electrodes, diagonally displaced along the lead axis and positioned within the right atrial cavity, are used to detect atrial activity that is then differentially processed within the pacemaker. P wave amplitude (amp) derived from a PSA-DAA device at implant was 1.38 +/- 0.28 mV. P wave signal amp derived from telemetered atrial electrograms was 1.29 +/- 0.22 mV at predischarge (n = 17), 1.31 +/- 0.24 mV at 3 months (n = 15), 1.30 +/- 0.24 mV at 6 months (n = 8), 1.51 +/- 0.34 mV at 9 months (n = 4), and 1.35 +/- 0.35 mV at 12 months (n = 2); and the far-field QRS signal measured at predischarge was of negligible voltage (0.17 +/- 0.07 mV). The susceptibility of the atrial sensor system to interference was noted with chest wall stimulation and only at higher sensitivities (0.1 to 0.3 mV) and not with isometric arm exercise. Intact VDD pacing function at rest and during exercise was established using Holter and periodic ECG monitoring. Postoperative complications included one lead displacement and one pocket hematoma. Three patients died postimplant of causes unrelated to pacemaker function. Advantages of the single-lead VDD pacing include: (1) elimination of second atrial sensing lead; (2) superior atrial sensing performance; (3) effective resistance to myopotential and far-field signal interference; and (4) stability of postimplant atrial signal amplitude.     

Differential Bipolar Sensing of a Dual Chamber Pacemaker

Differential bipolar sensing was evaluated in 10 consecutive patients with symptomatic heart block managed with dual chamber pacing. During pacemaker implantation atrial and ventricular electrograms were recorded using unipolar (UP) and differential bipolar (DBP) sensing amplifiers. The mean peak-to-peak amplitudes of the UP and DBP atrial electrograms were 3.3 +/- 1.2 mV and 4.2 +/- 1.2 mV, respectively. The difference was statistically significant (p less than 0.05). The mean peak-to-peak amplitudes of the ventricular electrograms were, respectively, 6.8 +/- 1.5 mV and 7.5 +/- 1.4 mV (p less than 0.01). Within 6 weeks after pacemaker implantation, patients visited the outpatient clinic. Isometric exercise tests were performed during UP and DBP sensing of the pacing system. Myopotential sensing in the ventricle occurred in nine patients during UP sensing and in none of the patients during DBP sensing (p less than 0.01) at a sensitivity setting of 0.5 mV. In addition, chest wall stimulation was performed to assess the effects of far-field signals on the ventricular sensing circuit of the pulse generator. Chest wall stimuli inhibited ventricular output during UP sensing in all 10 patients, whereas during DBP sensing inhibition of the ventricular channel occurred in three patients and then only at high output (greater than 8 V) settings. The susceptibility of the pacing system to crosstalk was also determined. However, neither during UP sensing nor during DBP sensing could cross-stimulation or cross-inhibition be demonstrated. In conclusion, DBP sensing is superior to UP sensing in terms of myopotential and far-field sensing.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical Evaluation of a Prototype Passive Fixation Dual Chamber Single Pass Lead For Dual Chamber ICD Systems

Dual chamber ICD systems use two separate leads for sensing. We developed and tested a new prototype of a single pass dual chamber passive fixation lead for dual chamber ICDs. Methods and Results: The prototype was a modification of the Guidant CPI Endotak DSP lead. The additional sensing electrode for the right atrium consisted of a side-mounted porous atrial ring electrode (AR). Atrial signals were recorded from the lead in patients during normal sinus rhythm (NSR), atrial fibrillation (AFib), and/or atrial flutter (AFl) with the AR in stable contact with the atrial wall or floating. During NSR, with the AR in contact with the atrial wall, an average P wave amplitude of 7.2 ± 1.5 mV (mean ± SD, n = 12) was measured. After induction of AFib/AFl, the single amplitude decreased to 3.6 ± 1.5 mV (n = 8) during AFib and 3.4 ± 1.7 mV (n = 9) during AFl. Amplitudes dropped between 53% and 75% when the AR lost atrial wall contact. The atrial pacing threshold was 1.0 ± 0.4 V (n = 16) when the AR was in contact with the atrial wall. Conclusions: In future dual chamber ICDs the signals from a passive fixation single pass lead could be used for atrial sensing and pacing as long as the sensing electrode for the right atrium remains in contact with the atrial wall. This system might lead to a simpler, less invasive implantation of dual chamber ICD systems.     

Bipolar ventricular far-field signals in the atrium

In an attempt to evaluate the prevalence and predisposing factors of bipolar ventricular far-field oversensing, 57 patients were studied who had a Medtronic dual chamber pacemaker implanted (models 7940: n = 6; 7960i: n = 41; 401: n = 3; 8968i: n = 7) and bipolar atrial leads with a dipole spacing from 8.6 to 60 mm attached to various parts of the atrial wall (lateral/anterior: n = 30; appendage: n = 10; atrial septum: n = 10; floating: n = 7). Median bipolar sensing threshold for P waves was 4.0 mV (2.8-4.0 mV, lower and upper quartile) with standard leads and 0.35 (0.25-1.4) mV with single pass (VDD) devices. At the highest sensitivity available, 43 of 50 DDD pacemakers but only two of seven VDD systems detected intrinsic R waves in the atrium (P < 0.01). Ventricular far-field oversensing occurred at 0.5 mV in 28 (56%) and at 1.0 mV in 16 of 50 DDD units (32%), respectively, and there was one observation in a septal implant at a sensitivity of even 2.8 mV. With ventricular pacing, VDD systems were as susceptible to far-field signals as DDD pacemakers. Outside the postventricular blanking period (100 ms), evoked R waves were detected by 27 of 57 systems (47%) at maximum atrial sensitivity, by 10 (18%) at 0.5 mV, and by 2 (4%) at a setting of 1.0 up to 1.4 mV, respectively. There was no definite superiority of any lead position, there was a trend in favor of the atrial free wall for better intrinsic R wave rejection, but just the opposite was the case for paced ventricular beats. Bipolar signal discrimination tended to be higher with short tip-to-ring spacing (1 7.8 mm) but the difference to larger dipole lengths (30-60 mm) was not significant in terms of the R to P wave ratio and the overall far-field susceptibility. In summary, bipolar ventricular far-field oversensing in the atrium is common with short postventricular blanking times and high atrial sensitivity settings that may be warranted for tachyarrhythmia detection and mode switching. A potentially more discriminant effect of shorter dipole lengths (< or = 10 mm) remains to be tested.     

Atrial Lead Placement During Atrial Fibrillation. Is Restitution of Sinus Rhythm Required for Proper Lead Function? Feasibility and 12‐Month Functional Analysis

Unexpected atrial fibrillation (AF) during implantation of an atrial pacemaker lead is sometimes encountered. Intraoperative cardioversion may lengthen and complicate the implantation process. This study prospectively investigates the performance of atrial leads implanted during AF (group A) and compares atrial sensing and pacing properties to an age- and sex-matched control group in which sinus rhythm had been restored before atrial lead placement (group B). Patient groups consisted of 32 patients each. All patients received DDDR pacemakers and bipolar, steroid-eluting, active fixation atrial leads. In patients with AF at the time of implantation (group A), a minimal intracardiac fibrillatory amplitude of at least 1.0 mV was required for acceptable atrial lead placement. In patients with restored sinus rhythm (group B), a voltage threshold < 1.5 V at 0.5 ms and a minimal atrial potential amplitude > 1.5 mV was required. Patients of group A in whom spontaneous conversion to sinus rhythm did not occur within 4 weeks after implantation underwent electrical cardioversion to sinus rhythm. Pacemaker interrogations were performed 3, 6, and 12 months after implantation. In group A, implantation time was significantly shorter as compared to group B (58.7 +/- 8.6 minutes vs 73.0 +/- 17.3 minutes, P < 0.001). Mean atrial potential amplitude during AF was correlated with the telemetered atrial potential during sinus rhythm (r = 0.49, P < 0.001), but not with the atrial stimulation threshold. Twelve months after implantation, sensing thresholds (1.74 +/- 0.52 mV vs 1.78 +/- 0.69 mV, P = 0.98) and stimulation thresholds (1.09 +/- 0.42 V vs 1.01 +/- 0.31 V, P = 0.66) did not differ between groups A and B. However, in three patients of group A, chronic atrial sensing threshold was < or = 1 mV requiring atrial sensitivities of at least 0.35 mV to achieve reliable atrial sensing. Atrial lead placement during AF is feasible and reduces implantation time. However, bipolar atrial leads and the option to program high atrial sensitivities are required.     

Cross-Talk in Bipolar Pacemakers

Investigation of dual chamber pacing and sensing interactions at high rates is becoming increasingly important with the advent of sensor driven dual chamber pacemakers. The present study was designed to investigate the pacemaker and lead interactions that will affect cross-talk during high rate atrial and ventricular pacing. The study was divided into two phases, phase one investigated the mechanisms of cross-talk using standard pacemaker circuitry and various electrode types in a canine model. In six dogs with complete heart block, dual chamber pacing was carried out with four lead types at increasing pacing rates, while output of the ventricular sense amplifier of a pacemaker breadboard was monitored. Ventricular sense amplifier output signals (n = 332) progressively increased from 31.5 +/- 18.3 mV at 100 ppm to 102 +/- 55 mV at 160 ppm. Smooth platinum-iridium and platinized leads were statistically different at higher pacing rates (P less than 0.05). This signal level is sufficient to lead to a ventricular sensing event. In a second phase of the study, the incidence of cross-talk at high pacing rates was studied in patients with implantable dual chamber bipolar pacemakers. In 166 clinical trials on 106 patients with the same pacemaker, there was evidence of cross-talk in 1/59 cases at 110 ppm and 3/47 at 130 ppm, but none at higher rates.(ABSTRACT TRUNCATED AT 250 WORDS)     

The Combined Transvenous Implantation of Cardioverter Defibrillators and Permanent Pacemakers

We developed criteria for implantation and programming of permanent endocardial pacemakers in patients with a nonthoracotomy ICD system. These criteria were prospectively used in 10 patients who recieved an ICD prior to (n = 5) or following (n = 5) implantation of a dual chamber (n = 6) or ventricular (n = 4) pacemaker with a unipolar (n = 4) or bipolar (n = 6) lead configuration. All patients were tested for interactions or malfunctions. Undersensing of ventricular fibrillation by the atrial sense amplifier and inadequate atrial pacing occurred in one patient with a unipolar dual chamber system programmed to AAIR but didn't impair ICD sensing. Transient or permanent loss of capture or sensing of the pacemaker was not observed after ICD shocks with the output programmed to double pulse width and voltage of stimulation threshold and the sensitivity to 50% of the detected R wave. One episode of transient reprogramming occurred without clinical consequences. One unipolar ventricular pacemaker lead had to be exchanged against a bipolar lead because of oversensing of the pacing artifact by the ICD. There was no failure of an ICD to detect ventricular arrhythmias due to inadequate pacemaker activity. During a follow-up period of 21 ± 11 months, a total of 78 ventricular arrhythmias were effectively treated in six patients. Thus, a combined use of transvenous ICD and pacemaker is possible despite the close vicinity of pacing and defibrillations leads. Optimized programming different to the common settings is required. As interactions occurred only in unipolar pacemaker leads bipolar systems should be used in these patients.     

Efficacy and Safety of Bipolar Sensing with High Atrial Sensitivity in Dual Chamber Pacemakers

In dual chamber pacemakers, atrial sensing performance is decisive for maintenance of AV synchrony. Particularly, the efficacy of mode switching algorithms during intermittent atrial tachyarrhythmias depends on the sensitive detection of low potential amplitudes. Therefore, a high atrial sensitivity of 0.18 mV, commonly used in single lead VDD pacemakers, was investigated for its efficacy and safety in DDD pacing. Thirty patients received dual chamber pacemakers and bipolar atrial screw‐in leads for sinus node syndrome or AV block; 15 patients suffered from intermittent atrial fibrillation. Pace makers were programmed to an atrial sensitivity of 0.18 mV. Two weeks, 3, 9, and 15 months after implantation, P wave sensing threshold and T wave oversensing thresholds for the native and paced T wave were determined. The myopotential oversensing thresholds were evaluated by isometric contraction of the pectoral muscles. Automatic mode switch to DDIR pacing was activated when the mean atrial rate exceeded 180 beats/min. The patients were followed by 24‐hour Holter monitoring. Two weeks after implantation, mean atrial sensing threshold was 1.81 ± 0.85 mV (range 0.25–2.8 mV) without significant differences during further follow‐up. Native T wave sensing threshold was < 0.18 mV in all patients. In 13% of patients, paced T waves were perceived in the atrial channel at the highest sensitivity. This T wave sensing could easily be avoided by programming a postventricular atrial refractory period exceeding 300 ms. Myopotential oversensing could not be provoked and Holter records showed no signs of sensing dysfunction. During a 15‐month follow‐up, 1,191 mode switch events were counted by autodiagnostic pacemaker function. Forty‐two of these events occurred during Holter monitoring. Unjustified mode switch was not observed. In DDD pacemakers, bipolar atrial sensing with a very high sensitivity is efficient and safe. Using these sensitivity settings, activation of the mode switch algorithm almost completely avoids fast transmission of atrial rate to the ventricle during atrial fibrillation.