Conventional Pacemaker Research Articles

Upgrade to biventricular pacing in advanced heart failure patients previously implanted with a conventional pacemaker for a classical indication: is it worth it?

Upgrade to biventricular pacing in advanced heart failure patients previously implanted with a conventional pacemaker for a classical indication: is it worth it?

Far-field P-wave sensing by the right ventricular lead of conventional dual chamber pacemakers.

This report describes two cases of far-field sensing of the P wave by the ventricular channel of conventional DDD pacemakers programmed to a relatively high sensitivity to promote sensing of ventricular extrasystoles. Ventricular pacing was maintained in both cases when the ventricular channel was not inhibited. One case was caused by displacement of a bipolar ventricular lead towards the right ventricular inflow tract. The other case occurred only in relation to an atrial extrasystole in the absence of ventricular lead displacement.

Biventricular pacing in patients with congestive heart failure: two prospective randomized trials

Epidemiologic studies suggest that 20–30% of patients diagnosed with symptomatic congestive heart failure (CHF) have intraventricular conduction disorders characterized by a discoordinate contraction pattern and wide QRS. Biventricular pacing is an emerging therapy allowing simultaneous electrical stimulation of the right and left ventricles with the use of an implantable pacing system. The aim of this article is to describe 2 prospective randomized multicenter trials examining the effects of biventricular pacing on functional capacity, quality of life, and hemodynamic status in patients with dilated cardiomyopathy and intraventricular delay. The VIGOR CHF Trial is designed to assess functional and symptomatic improvement in heart failure patients with biventricular pacing and without a concomitant indication for conventional bradycardia pacemaker therapy. To assess for potential placebo effects, patients are randomized to receive either biventricular pacemaker therapy or no pacing therapy for the first 6 weeks, after which both groups receive pacing therapy. The VENTAK CHF trial uses an implantable cardioverter defibrillator system (ICD) designed to provide chronic biventricular pacing therapy in addition to treating ventricular tachyarrhythmias. All patients receive conventional ICD and CHF therapy throughout the study and are randomized in a 2-period crossover design to receive either no pacing or biventricular pacing for 3-month intervals. Patient enrollment in both studies is ongoing, with a closed analysis. The unique designs of these trials provide the opportunity to study this therapy in high-risk patients who have been optimally treated for heart failure.

Prospective evaluation of shoulder-related problems in patients with pectoral cardioverter-defibrillator implantation

Background: The pectoral approach to implantation of cardioverter defibrillators (ICDs) has become a standard in defibrillator therapy because of reduced generator size, weight, and volume. But the size of these devices is still comparable to the size of the early conventional antibradycardia pacemakers that were associated with a number of significant pocket- and shoulder-related problems after implantation in the pectoral region. In a prospective, single-center study of 50 patients with subpectoral implantation of a fourth-generation ICD, the ipsilateral shoulder joint was evaluated regarding active shoulder motility, shoulder-related pain, shoulder function, shoulder elevation, insertion tendinitis, and morphologic alterations of the shoulder. Methods and Results: The shoulder was evaluated before implantation and at 3, 6, and 12 months after implantation. Shoulder motility was documented by evaluating active abduction, forward flexion, and external rotation. Shoulder-related pain and function were documented by the "Basic Shoulder Evaluation Form," insertion tendinitis was diagnosed by standardized palpation and the impingment test, and morphologic alterations were documented by ultrasound and radiograph of the shoulder. Three months after implantation, 20 (40%) patients had a reduced active abduction, 30 (60%) patients had an impaired active forward flexion, and eight (16%) patients had a reduced external rotation. Thirty-one (62%) patients reported shoulder-related pain or impaired shoulder function according to the "Basic Shoulder Evaluation Form." Twenty-four (48%) patients showed a shoulder elevation and 21 (42%) patients demonstrated clinical signs of insertion tendinitis. After 12 months the number of patients with reduced active abduction, forward flexion, and external rotation dropped to four (8%). Shoulder-related pain and reduced function were documented in seven (13%) patients, four (8%) patients still had shoulder elevation, and five (10%) patients still had signs of insertion tendinitis. None of the postoperatively performed ultrasounds or radiographs showed any pathologic shoulder alterations. No predictors for the occurrence of shoulder-associated problems could be found. Conclusions: (1) Decreased active shoulder motility, shoulder-related pain, reduced function, shoulder elevation, and insertion tendinitis of the ipsilateral shoulder joint are diagnosed in many patients 3 months after subpectoral ICD implantation. (2) After 12 months the number of patients with impaired shoulder motility, function, shoulder-related pain, shoulder elevation, and insertion tendinitis decreased significantly. (3) Ultrasound and radiographs of the ipsilateral shoulder showed no evidence of pathologic morphologic alterations after subpectoral ICD implantation. (4) No shoulder-associated problems required an operative revision of the subpectoral generator pocket. (Am Heart J 1997;134:577-83.)

Continuous ambulatory haemodynamic monitoring with an implantable system. The feasibility of a new technique.

This study evaluates the feasibility and safety of a completely implantable system for long-term ambulatory monitoring of important haemodynamic parameters in patients with severe cardiopulmonary disease. The design of the implantable monitoring system is similar to a conventional single lead pacemaker. A lead with incorporated biosensors for the continuous recording of pressure and oxygen saturation signals is positioned in the right ventricle and connected to a monitor and memory device subcutaneously implanted like an ordinary pacemaker can. Five patients with implanted haemodynamic monitoring systems have been followed for from 7 to 16 months. Continuous measurements of activity, heart rate, mixed venous oxygen saturation and estimated pulmonary artery diastolic pressure were registered with variable resolution during daily living and predefined provocations. The memory covered a maximum of 3 weeks at low resolution. The monitored parameters showed an adequate and significant response to various haemodynamic situations. Except for the demand of recalibration of two oxygen sensors, there were no technical problems and the quality of data were excellent. Long-term ambulatory haemodynamic monitoring is feasible and potentially useful for the management of patients with severe cardiopulmonary disease.

Clinical results with single lead VDD pacing.

For patients with atrioventricular block single lead atrial synchronous ventricular pacing (VDD) may have advantages compared to conventional dual chamber pacing (DDD) since it eliminates the need for an atrial lead. The purpose of this study was to investigate the clinical performance of a novel VDD pacemaker and the reliability of atrial sensing via the "floating' atrial electrode. 31 patients (10 females; age 64 +/- 13 years) underwent an implantation of a VDD pacemaker system (Intermedics UNITY). The patients were analyzed with regard to implantation parameters, complications and postoperative atrial sensing performance using the diagnostic data of the pacemaker memory. The mean follow-up was 6.3 (1-18) months. The implantation procedure did not differ from that of conventional single chamber pacemakers. Dislocation of a ventricular electrode was the only complication observed. The P wave at implantation was 1.6 +/- 0.9 mV and dropped to 0.9 +/- 0.4 mV at predischarge. During follow-up the atrial sensing threshold remained stable. The atrial sensing performance (percentage of atrial synchronous ventricular complexes) after reprogramming the highest atrial sensitivity was 99.7%. Two patients (6%) developed atrial fibrillation. 29 patients (94%) remained in VDD mode as primarily intended. From these results it is concluded that VDD pacing represents an excellent alternative in patients with atrioventricular block and intact sinus node function. The atrial sensing was found to be reliable.

The value of DDD pacing in patients with an implantable cardioverter defibrillator.

Although the beneficial effects of DDD pacing are well known, currently available ICDs provide only fixed rate ventricular antibradycardia pacing. In a consecutive series of 139 patients with ICDs, we have analyzed the need for antibradycardia pacing and the indications for DDD pacing. We also report our initial experience with the Defender 9001 (ELA Medical, France) DDD-ICD. Out of 139 patients, 25 (18%) were in need of antibradycardia pacing. Ten patients already had a pacemaker at the time of ICD implantation and ten other patients had a conventional pacemaker indication at that time. Five patients became pacemaker dependent during a follow-up of 20 +/- 8 months. The disorders necessitating pacemaker therapy were high degree AV conduction disturbances in 72%, sick sinus syndrome in 12%, and AF with a slow ventricular response in 16% of patients. Based upon current indications, DDD pacing was indicated in 20 (80%) of 25 patients. The Defender 9001 DDD-ICD (ELA Medical) was used in two patients with ischemic cardiomyopathy and pacemaker syndrome with VVI pacing. Cardiac output during DDD pacing increased by 36% in one patient with an increase in VO2 max during exercise of 29%. The other patient showed an increase in cardiac output of 50% with DDD pacing, and, while unable to exercise with VVI pacing, had a VO2max of 24 mL/kg per minute during DDD pacing. Up to 18% of our ICD patients are in need of antibradycardia pacing. Of these pacemaker dependent patients, 80% have an indication for DDD pacing. Our first clinical experience with a DDD-ICD confirms the hemodynamic benefit of AV synchronous pacing in ICD patients with pacemaker syndrome.

Comparison of Two Activity-Controlled Rate-Adaptive Pacing Principles: Acceleration versus Vibration

Activity-guided rate-adaptive pacing is currently the most widely used principle for rate adaptation. Broad experience has been gathered from several hundred thousand pacemakers that adjust the pacing rate according to vibrational forces detected by a piezosensor bonded to the inner side of the pacemaker can. A new generation of accelerometer-based pacemakers has been introduced into clinical practice. The vibrational type detects vibration, pressure, and shock waves traveling through the body with physical stress and using the pacemaker can as a resonator. In contrast, the accelerometer is insulated from the pacemaker housing and is incorporated into electronic hybrid circuitry. The forces detected by an accelerometer are motion and acceleration of the body in an anterior-posterior direction. Clinical studies conducted to date have shown that the accelerometer to be superior to the conventional vibration activity pacemakers, as far as the discrimination of different workloads and rejection of unwanted environmental noise are concerned.

Usefulness of transcutaneous triggering of conventional implanted pulse generators by an activity-sensing pacemaker for predicting effectiveness of rate response pacing

A noninvasive procedure has been developed to assess effectiveness of activity-sensing rate response ventricular (VVIR) pacing systems in patients with implanted conventional fixed-rate ventricular (VVI) pacemakers capable of triggered mode operation (VVT). A VVIR pacemaker (activity threshold medium or low, rate response 6 to 10, upper rate 125 or 150 beats/min) was strapped to the chest wall (prepectoral area) of patients with previously implanted fixed-rate VVI pacemakers. In 17 of the 18 patients included in the study, the implanted pacemaker was capable of triggered mode operation (VVT). Triggering of the conventional pacemaker was achieved by reprogramming it to the VVT mode (high sensitivity, short refractory) and connecting the output of the “strapped-on” VVIR pacemaker (5 volts, 1.5-ms pulse width) to 2 standard cutaneous electrodes positioned so as to be in proximity to the implanted intracardiac electrode system. Patients underwent symptom-limited treadmill exercise tests during both VVI and VVIR pacing. Triggering conventional VVI pulse generators by a “strapped-on” VVIR pacing system proved feasible in 16 of 17 cases and improved overall heart rate response (fixed rate 86 ± 22 vs VVIR 118 ± 7 beats/min) and exercise duration (fixed rate 6.6 ± 4.9 vs VVIR 10.1 ± 4.8 minutes) (mean values for all patients studied during exercise testing). Triggering of a previously implanted permanent pacemaker by a strapped-on activitytriggered device may be useful to assess rate response pacing before implantation of a VVIR device in patients in whom elective pulse generator replacement is planned.

Sensor-triggered, rate-variable cardiac pacing. Current technologies and clinical implications.

Conventional implantable dual-chamber cardiac pacemakers adjust heart rate and maintain normal atrial and ventricular contraction by tracking "native" atrial electrical activity and pacing the ventricles after a predetermined programmable atrioventricular delay. However, in patients with symptomatic bradyarrhythmias, optimal function of "atrial-tracking" devices may be limited by concomitant sinoatrial disease. Provision of chronotropic response during physical exertion or emotional stress may be achieved by using physiologic sensors to alter pacing rate independently of atrial activity. Additional systems using sensor technologies are being developed. Future pacing systems will have dual-chamber pacing capability and may use several sensors coupled synergistically in order to take advantage of particular strengths of each. Physiologic sensor technology may be of diagnostic value in both antitachycardia devices and implantable cardioverter and defibrillator systems.

Surgical treatment of arrhythmias: Current status and future directions

A variety of surgical interventions have evolved for the treatment of intractable or life-threatening arrhythmias unresponsive to conventional pharmacologic or pacemaker therapy. Supraventricular arrhythmias associated with rapid ventricular responses can be indirectly treated with ablation of the atrloventricular conduction system and insertion of a pacemaker. Ventricular tachyarrhythmias have previously been treated with sympathectomy, resection of tissue or revascularization. More recent approaches include the simple ventriculotomy, encircling endocardial ventriculotomy, cryosurgical ablation and insertion of the automatic implantable defibrillator. Refinement of methods to localize more precisely the origin of ventricular arrhythmias may allow design of more direct surgical procedures. The surgical treatment of arrhythmias related to the preexcitation syndromes remains the model of electrophysiologic surgery. It is now feasible to divide accessory pathways with a high degree of success and at low risk in selected patients.

Performance of implanted biogalvanic pacemakers.

Seventeen unipolar cardiac pacemakers powered by hybrid biogalvanic cells were implanted in dogs. Long term clinical effects and electrical performance in vivo of the generators were investigated. The biogalvanic cells were designed to provide 50 years of generator operation. No systemic pathological changes which would be attributed to the generator or the biogalvanic cell were observed. Local reaction to implants was mild and not significantly different from the one observed in conventional pacemaker implantations to date. The electrical performance of the biogalvanic cells was very encouraging. Final steady-state cell voltage levels of .65V to .75V were reached in 100--150 days after implantation and remained constant in 3 units to date which represents over 36 months after implantation for each generator.

Undesirable cardiac arrhythmias associated with rate hysteresis pacemakers

The introduction of the ventricular inhibited pulse generator with the feature of rate hysteresis has been associated with a variety of rhythm disturbances, some causing serious concern. This pulse generator has two different pacing rates: (1) the automatic rate, which is the interval between two successive paced beats (usually 860 msec or 70/min), and (2) the hysteresis interval, which results in a 1,000 msec delay between a sensed cardiac contraction and the next pacemaker discharge. The hysteresis interval after a sensed signal may result in long pauses that may predispose to the development of serious cardiac arrhythmias. Two examples of this type of complication were recently observed. One patient had bigeminal rhythm with mechanically ineffective cardiac contractions and an effective cardiac rate of 35/min; he experienced dyspnea and weakness during these prolonged episodes. Another patient had repeated episodes of ventricular fibrillation. The cardiac arrhythmias were not controlled by antiarrhythmic agents, and both patients required replacement of the pulse generator. The proposed advantages of pulse generator hysteresis are (1) prolongation of battery life, and (2) maintenance of effective atrial transport; these advantages may be outweighed by undesirable cardiac arrhythmias that may be associated with this mode of pacemaker function. Rate hysteresis cardiac pacemakers should be reserved for patients having predominantly sinus rhythm without ventricular irritability. In patients with frequent ectopic ventricular activity, atrial fibrillation or high degree atrioventricular block, the rate hysteresis pacemaker offers no advantage over the conventional demand pacemaker. For patients with frequent ectopic ventricular activity not easily controlled by antiarrhythmic agents, consideration should be given to the use of a permanent demand pacemaker with external rate control, which may provide greater flexibility in arrhythmia management.

The Rechargeable Cardiac Pacemaker

After five years of laboratory development and in vivo testing, a rechargeable cardiac pacemaker with R-wave inhibited demand circuitry was introduced into clinical use in February 1973. We have used the rechargeable pacemaker in 25 patients in the past 1 1/2 years. The series includes 14 women and 11 men, with an age range of 38 to 80 years. Eleven of the patients had the rechargeable system implanted as a replacement for a failing or a failed conventional pacemaker. These 11 patients accounted for 26 previous pacemakers. The rechargeable pacemaker is smaller than conventional pacemakers, and it promises to obviate the need for periodic pulse generator replacement. Our initial experience with the rechargeable pacemaker has been favorable, and patient acceptance has been good.

Selective coronary arteriography during permanent ventricular tachycardia

A variety of surgical interventions have evolved for the treatment of intractable or life-threatening arrhythmias unresponsive to conventional pharmacologic or pacemaker therapy. Supraventricular arrhythmias associated with rapid ventricular responses can be indirectly treated with ablation of the atrloventricular conduction system and insertion of a pacemaker. Ventricular tachyarrhythmias have previously been treated with sympathectomy, resection of tissue or revascularization. More recent approaches include the simple ventriculotomy, encircling endocardial ventriculotomy, cryosurgical ablation and insertion of the automatic implantable defibrillator. Refinement of methods to localize more precisely the origin of ventricular arrhythmias may allow design of more direct surgical procedures. The surgical treatment of arrhythmias related to the preexcitation syndromes remains the model of electrophysiologic surgery. It is now feasible to divide accessory pathways with a high degree of success and at low risk in selected patients.

Self-synchronizing cardiac pacemaker.

A new kind of cardiac pacemaker for direct heart stimulation in cases of intermittent or variable heart block is presented. The pacemaker is capable of providing stimuli either synchronously with ventricular depolarization or at a fixed rate when natural pacing fails. Thus any competition between artificial and physiological rhythm is avoided, while allowing the exploitation, from the hemodynamic viewpoint, of the surviving capability of physiologic control of the heart rate. The main features of the instrument are that the shifts from synchronous to free operation and vice versa take place in an automatic way, and no electrode besides those which provide stimulation are needed for synchronization. The mean power consumption of the pacemaker is comparable with that of conventional unsynchronized pacemakers. Thus the subcutaneous implantation is possible, with a theoretical lifetime of 30 000-hour autonomy. Schematic diagrams and waveforms are included.