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Europace Advance Access originally published online on February 10, 2006
Europace 2006 8(3):216-220; doi:10.1093/europace/euj027
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


PACING

Role of ventricular autocapture function in increasing longevity of DDDR pacemakers: a prospective study

Giuseppe Boriani1,*, Luigi Rusconi2, Mauro Biffi1, Letterio Pavia3, Massimo Sassara4, Dario Malfitano5, Maria Grazia Bongiorni6, Luigi Padeletti7, Ignazio Filice8, Daniela Sanfelici9, Pietro Maffei10, Alfredo Vicentini11, Angelo Branzi1 and on behalf of Autocapture Study Group

1 Institute of CardiologyUniversity of BolognaAzienda Ospedaliera Policlinico S.Orsola-Malpighi, Via Massarenti, 9 40138 Bologna Italy ; 2 Ospedale CeccariniRiccione Italy ; 3 Ospedale PiemonteMessina Italy ; 4 Ospedale Grande degli InfermiViterbo Italy ; 5 Ospedale GravinaCaltagirone Italy ; 6 Ospedale. CisanelloPisaItaly ; 7 Ospedale CareggiFirenze Italy ; 8 Ospedale S. PaoloSavona Italy ; 9 Ospedale Santa CoronaPietra Ligure Italy ; 10 Ospedale di Sanremo Italy ; 11 Clinica PederzoliPeschiera del Garda Italy

Manuscript submitted 13 June 2005. Accepted after revision 30 September 2005.

* Corresponding author. Tel: +39 051 6363531; fax +39 051 344859. E-mail address: cardio1{at}almadns.unibo.it


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
Aims Autocapture is an algorithm for automatic adaptation of ventricular output to capture threshold. The aim of this prospective study was to estimate the effects of ventricular Autocapture algorithm on DDD–DDDR pacemaker longevity.

Methods and results Eighty-three patients implanted with a DDD–DDDR pacemaker (Affinity or Entity; St Jude Medical, USA) were enrolled and the Autocapture function was activated pre-discharge. Ventricular pulse duration was randomly programmed at 0.3 or 0.4 ms, with a cross-over at 8–12 weeks and again at 13–14 months. Diagnostic data were retrieved from device memory and by calculating battery current drain from long-term threshold recordings; device longevity was estimated at the following settings: Autocapture with a pulse duration of 0.3 and 0.4 ms, respectively, standard output (3.5 V, 0.4 ms) and conventional low output programming (2.5 V, 0.4 ms). According to a series of assumptions, Autocapture was associated with a 55–60% increase in estimated device longevity compared with standard output programming and a 6–7% increase in longevity compared with low output programming. No significant differences were found between Autocapture programmed with a pulse duration of 0.3 or 0.4 ms. In projections to a 10-year follow-up, use of the Autocapture function resulted in a 42% reduction in pacing-related estimated costs compared with standard output programming at 3.5 V, 0.4 ms.

Conclusion Pacing with constant adaptation of ventricular output in dual-chamber devices has the potential to increase generator longevity and to reduce sizeably pacing-related costs compared with standard programming.

Key Words: Autocapture, Cardiac pacing, Cost-effectiveness, Stimulation threshold


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
The longevity of an implantable cardiac pacemaker is determined by the capacity of the battery, its chemistry, and current drain.1Go–3Go To improve pulse generator longevity, pacing systems with low output stimulation, capable of monitoring ventricular capture and automatically adjusting the output to correct for transient loss of capture have been designed.4Go–10Go Maintenance of effective ventricular cardiac stimulation is an obvious requirement to guarantee patient safety, despite the variability in stimulation threshold and the possibility of transient increases in stimulation threshold due to metabolic and pharmacological factors.11Go Autocapture is a system for continuous and automatic adaptation of ventricular output to capture threshold. Its increased generator longevity in VVI–VVIR devices compared with standard programming at conventional low-energy settings has been demonstrated.12Go

The aims of the prospective study were to (i) calculate the battery current drain in a population implanted with a series of DDD–DDDR pacemakers capable of automatic sampling of ventricular stimulation threshold and of automatic adjustment of ventricular output known as Autocapture, (ii) evaluate the effect of ventricular Autocapture function on longevity of a dual-chamber device, and (iii) calculate the potential impact of this feature on long-term pacing-related costs.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
Patient population
Patients with conventional indications for dual-chamber cardiac pacing with advanced atrioventricular block (stable or paroxysmal), in whom constant stimulation of at least 75% of the total beats was expected after pacemaker implant, were considered for the study. Written informed consent was obtained from all the patients.

Material and study design
The study was designed to calculate the battery current drain and device longevity by evaluating ventricular pacing output during long-term follow-up of a group of patients who had received a dual-chamber pacemaker with Autocapture function (Affinity DR 5330 and DC 5230 or Entity DR 5326 and DC 5226, St Jude Medical, USA) with a battery capacity of 0.95 Ah. As previously reported in detail,4Go–7Go Autocapture is a programmable option for automatic adaptation of ventricular device output to stimulation threshold, in order to guarantee continuous ventricular capture. All patients had received low polarization, low threshold bipolar ventricular leads (Membrane E and EX, St Jude Medical). At implantation, conventional measurements of lead impedance, pacing threshold, sensing amplitude, and slew rate were performed. Ventricular evoked response was measured in order to allow proper functioning of the Autocapture algorithm.

In accordance with the study protocol, patients, pre-discharge, underwent (i) active programming of Autocapture and (ii) randomized allocation to a ventricular pulse duration of 0.3 or 0.4 ms. A cross-over for ventricular pulse duration was scheduled at 8- and 12-week follow-up visits. Analysis of data obtained from the ventricular threshold vs. time recordings, retrieved at 8- and 12-week, 13- and 14-month follow-up visits using a sampling frequency of 6 h (with a total sampling time of 32 days), was performed to calculate battery current drain and to estimate device longevity under multiple output settings: (i) Autocapture at 0.3 ms pulse duration in the ventricle and 2.5 V, 0.4 ms in the atrium; (ii) Autocapture at 0.4 ms pulse duration in the ventricle and 2.5 V, 0.4 ms in the atrium; (iii) standard programming at 3.5 V, 0.4 ms in the atrium and the ventricle; (iv) conventional low output programming at 2.5 V, 0.4 ms in the atrium and the ventricle. The Autocapture setting provides a ventricular output equal to the capture threshold increased by 0.25 V. The estimated pacing-related costs of the device provided with Autocapture function were compared with those estimated by the device at conventional low output settings, using a series of assumptions already reported.12Go

Data analysis
A series of factors known to affect current drain and pacemaker longevity were considered.12Go As documented, pacemaker longevity is inversely proportional to current consumption and is directly proportional to battery capacity, such that the larger the battery and/or the lower the current drain, the greater the longevity expected from the device, according to the formula L=114*C/I,1Go where L, device longevity (years); C, battery capacity (Ah); I, battery current (µA). The total amount of current is calculated as the sum of the house-keeping current (i.e. the current for internal device functions correspondent to 11.2 µA)+the current for normal and backup pulses. Calculations have been carried out considering a basic rate of up to 60 bpm, assuming 100% pacing either at atrial or ventricular level. Data on ventricular pacing threshold and on output pulse amplitude were retrieved from diagnostics stored in the memory of the device, allowing the availability of detailed data on the pacing threshold in two 4-week periods (i.e. between the 8th and 12th week, and between the 13th and 14th month after device implant). For each patient follow-up, the corresponding pacing threshold graph was evaluated using a 6 h sampling rate providing the rough data from which the current drain calculations were performed.12Go When Autocapture was active, calculation of longevity included a rate of 0.8% of backup ventricular pulses (stimulation at 4.5 V and at the programmed pulse duration) over the entire time period considered, according to the data obtained from the manufacturer.

Projections of the costs of the DDD/DDDR pacing system at different settings, with or without activation of the Autocapture function, were based on partial modification of the assumptions published by Sutton and Bourgeois.12Go,13Go In detail, the following costs in arbitrary currency units were considered:12Go 166 currency units for the dual-chamber device, 26 units for the two leads, 148 units both for implant and replacement procedure, and 8 units for each follow-up visit. Two follow-up visits per year were considered when the Autocapture was not active (three for the first year) and one follow-up visit per year when it was active (two for the first year and after the fourth year).12Go

Statistical analysis
All data related to current drain and generator longevity were analysed comparing mean values by repeated measures analysis of variance (SPSS Advanced Statistics, SPSS Inc., Chicago, IL, USA) with a P-value less than 0.05 to define statistical significance. For cost comparison, the limited number of discrete observations related to the investigated period (10 years) makes a time series analysis not feasible. The comparison has, therefore, been performed as analysis of variance with the ‘repeated measures’ design.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
Eighty-three patients (60 men, 23 women) were enrolled in the study and all reached the 12-week follow-up. Thirty-two patients completed the follow-up at 14 months after implant. The mean age was 74±10 years (range 42–94). During the study period, no clinical complications were observed.

At 12-week and at 14-month follow-up visits, ventricular pacing impedance was 702±143 {Omega} (range 435–1289 {Omega}) and 711±150 {Omega} (range 430–1289 {Omega}), respectively; atrial pacing impedance was 604±131 {Omega} (range 397–1073 {Omega}) and 652±120 {Omega} (range 402–929 {Omega}), respectively. Evoked response amplitude was 13.3±6.1 mV (range 3.0–29.9 mV) and 12.7±5.5 mV (range 2.8–26.4 mV) at 12 weeks and 14 months, respectively, and amplitude of polarization signal was 0.65±0.52 mV (range 0.20–2.74 mV) and 0.63±0.57 mV (range 0.20–3.33 mV), respectively. The mean output voltage (Autocapture +0.25 V) at 0.3 ms pulse duration during 4–12 weeks and 12–14 months was 1.25±0.32 V (range 0.75–2.09 V) and 1.25±0.40 V (range 0.80–2.73 V), respectively, whereas at 0.4 ms pulse duration, it was 0.99±0.22 V (range 0.69–1.43 V) and 1.01±0.41 V (range 0.63–2.38 V), respectively. At 12-week follow-up, the actual percentage of ventricular pacing was >75% in 90% of the patients and >90% in 57% of the patients. These figures were comparable at the 14-month follow-up.

Using recorded data (29 392 samples), current drain and generator longevity (time to recommended replacement time) were calculated for the different settings defined and for the two separate monitoring periods. Programming Autocapture function in Affinity or Entity pacemakers with a pulse duration of 0.4 ms resulted, according to data collected in the first study period (up to 12 weeks after implant), in a 60% increase in estimated longevity compared with standard output programming and in a 7% increase in estimated longevity compared with low output programming. According to data collected 12–14 months after implant, Autocapture resulted in a 55% increase in estimated longevity compared with standard output programming and in a 6% increase in estimated longevity compared with low output programming (Figs 1 and 2). No difference emerged considering the use of Autocapture associated with a programmed pulse duration of 0.3 or 0.4 ms.


Figure 0271
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Figure 1 Projections of device longevity for different programming based on threshold data measured at 8–12 weeks of follow-up.

 


Figure 0272
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Figure 2 Projections of device longevity for different programming based on threshold data measured at 13–14 months of follow-up.

 
The cumulative costs of a pacing device and leads including implantation, follow-up visits, and replacement over the long-term, based on previously described assumptions and computed in units of cost for the projected longevity, are shown in Fig. 3. In a projection at 10 years, activation of Autocapture function appeared to be associated with a 42% reduction in pacing-related costs compared with a standard setting of 3.5 V, 0.4 ms output.


Figure 0273
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Figure 3 Projections of pacing-related costs during a 10-year follow-up based on described assumptions. AC, pacing with Autocapture at 0.4 ms pulse duration; 3.5 V, pacing with standard programming at 3.5 V, 0.4 ms in the atrium and ventricle; 2.5 V, pacing with conventional low output programming at 2.5 V, 0.4 ms in the atrium and ventricle.

 
Analysis of threshold data revealed that stimulation thresholds >2.5 and 1.5 V occurred in 4 (5%) and 20 patients (24%), respectively; this analysis did not take into consideration the first month after implant and considered only threshold trends indicating an evident threshold increase.


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
The prolongation of pulse generator longevity is an important goal to be achieved in order to reduce the costs of cardiac pacing.2Go Considering that pacing threshold may vary significantly as a result of several factors,11Go programming the pacemaker at a low output in order to increase the service life is limited by the necessity to maintain a safety margin with a 2:1 ratio14Go and may be time consuming. Pacing at low output has been used only in a small proportion of patients in clinical practice before the availability of systems with automatic capture verification and adaptation of output to threshold.15Go

This study demonstrates the important implications of the Autocapture function which promotes the extension of projected pulse generator longevity, while maintaining an adequate safety margin in case of fluctuations in stimulation threshold. The automatic ventricular output regulation guaranteed by the Autocapture function has provided effective stimulation in those patients (5–24 % of the population) in whom conventional low output programming would have caused an inadequate safety margin for ventricular capture, with the potential for adverse events. The reliable safety profile of the same Autocapture system that we used, on a beat-by-beat basis, has been recently confirmed in an observational study on 83 patients, implanted with either VVIR or DDDR pacing systems.16Go In that study, Autocapture allowed safe ventricular pacing even in a subgroup of five patients with large variations (>1 V) in ventricular capture threshold that would have required a larger safety margin than commonly applied using standard devices without the Autocapture feature.

The present study shows how the use of Autocapture is associated with significant advantages in device expected longevity in comparison with different output settings. The Autocapture function in a dual-chamber pacemaker (Affinity DR or Entity DR, in this study), permits a service life of about 11 years, 4 years longer than that expected with standard programming of the same pacemaker and about 8–9 months longer than that expected using conventional low output programming.

At present, such a service life seems particularly useful and appropriate in light of epidemiological studies indicating that patient longevity has improved substantially and is expected to extend further in coming years.17Go,18Go Sutton and Bourgeois13Go calculated a 61–71% survival rate at 10 years in patients with AV block or SSS implanted with a DDD pacemaker. Recently, a longitudinal study of unselected patients followed for 30 years in a pacemaker clinic showed an overall survival of 44.8 and 21.4% at 10 and 20 years, respectively, with a net improvement in prognosis in the last decade.18Go

The availability of pacemakers with a long projected service life seems to be concordant with the need to contain the costs of long-term cardiac pacing.2Go,13Go,15Go Our projections of costs savings determined by the Autocapture feature in comparison with different settings show a reduction of up to 42% is achievable at 10 years of follow-up. In this study, randomized programming to a pulse duration of 0.3 or 0.4 ms allowed a comparison to demonstrate that there is no significant difference in projected longevity using these two programmed values. Therefore, in clinical practice, the choice of pulse duration to be programmed in combination with Autocapture may be left to physician preference, although a lower duration theoretically would imply an advantage in expected longevity, although of limited, if not negligible, extent.

The positive effects demonstrated by this study in terms of longevity of the device and of relative costs should be even more considerable when the Autocapture function is evaluated in devices with low internal energy consumption circuitry and in devices with automatic regulation of output also in the atrial channel.19Go

Study limitations
The present study has some limitations. The longevity of the devices was not directly measured; it was estimated on the basis of projections and calculations derived from data on ventricular pacing threshold and on output pulse amplitude. All the projections and calculations were applied to devices from the same manufacturer. Therefore, these results cannot be extrapolated to other DDD–DDDR devices currently used in clinical practice. Moreover, device management matters, such as long-term troubleshooting, and infections or lead complications were not taken into account.


    Conclusions
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
Projections of device longevity based on threshold data prospectively monitored during the follow-up of patients implanted with a DDD–DDDR device indicate that a device algorithm for automatic adaptation of ventricular output may increase significantly the service life in comparison with the same pacemaker with standard or conventional low output programming. These estimates also indicate that using the Autocapture algorithm a significant reduction in projected costs of pacing may be expected. Confirmation of long-term projections will require prospective evaluations in larger number of patients over longer follow-up periods. According to our data, programming of pulse duration at 0.3 or at 0.4 ms in combination with Autocapture did not result in relevant differences with regard to estimated longevity or costs.


    Appendix
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
List of investigators and co-ordinators for the Autocapture Study Group. Bologna, Institute of Cardiology, Azienda Ospedaliera S. Orsola-Malpighi: G. Boriani, M. Biffi, L. Frabetti; Riccione, Ospedale Ceccarini: L. Rusconi; Messina, Ospedale Piemonte: L. Pavia; Viterbo, Ospedale Grande degli Infermi: M. Sassara, R. Guerra; Caltagirone, Ospedale Gravina: D. Malfitano; Pisa, Ospedale. Cisanello: M.G. Bongiorn, M. Ratti; Firenze, Ospedale Careggi: L. Padeletti, P. Pieragnoli; Savona, Ospedale. S. Paolo: M. Gazzarata, G.B. Siri, I. Filice; Pietra Ligure, Ospedale Santa Corona: D. Sanfelici; Ospedale di Sanremo: P. Maffei; Peschiera del Garda, Clinica Pederzoli: A. Vicentini; S. Marino, Istituto di Sicurezza Sociale: T. Lisi, L. Marinelli; Rivoli, Ospedale degli Infermi: A. Sibona; Imperia, Ospedale Civile: G. Musso, R. Mureddu, S. Aquarone; Milano, St. Jude Medical Italy: Paolo Giovanzana, Antonio Mininno.


    Acknowledgement
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
The authors thank Paolo Giovanzana, Francesco Junginger and Antonio Mininno, St Jude Medical, Italy, for technical and scientific collaboration.


    References
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Conclusions
 Appendix
 Acknowledgement
 References
 
[1] Furman S. Basic concepts. In Furman S, S S, Hayes S, DL S, Holmes Jr DR (Eds.). A Practice of Cardiac Pacing 1993; 3rd ed. Mt Kisco, NY Futura Publishing Co pp. p68–71 In:.

[2] Ohm OJ and Danilovic D. Improvements in pacemaker energy consumption and functional capability: four decades of progress. Pacing Clin Electrophysiol 1997; 20: 2–9.[CrossRef][Medline]

[3] Schuchert A and Meinertz T. A randomized study on the effects of pacemaker programming to a lower output on projected pulse generator longevity. Pacing Clin Electrophysiol 2001; 24: 1234–9.[CrossRef][Medline]

[4] Sermasi S, Marconi M, Libero L, Moracchini PV, Rusconi L, Mininno A, et al. Italian experience with Autocapture in conjunction with a membrane lead. Pacing Clin Electrophysiol 1996; 19: 1799–804.[CrossRef][Medline]

[5] Clarke M, Liu B, Schuller H, Binner L, Kennergren C, Guerola M, et al. Automatic adjustment of pacemaker stimulation output correlated with continuously monitored capture thresholds: a multicenter study. Pacing Clin Electrophysiol 1998; 21: 1567–75.[CrossRef][Medline]

[6] Schuchert A, Ventura R, Meinertz T. Automatic threshold tracking activation without the intraoperative evaluation of the evoked response amplitude. AUTOCAP Investigators. Pacing Clin Electrophysiol 2000; 23: 321–4.[CrossRef][Medline]

[7] Lau C, Cameron DA, Nishimura SC, Ahern T, Freedman RA, Ellenbogen K, et al. A cardiac evoked response algorithm providing threshold tracking: a North American multicenter study. Clinical evaluation of the Microny-Regency Clinical Evaluation Study. Pacing Clin Electrophysiol 2000; 23: 953–9.[CrossRef][Medline]

[8] Madrid AH, Olague J, Cercas A, del Ojo JL, Munoz F, Moro C, et al. A prospective multicenter study on the safety of a pacemaker with automatic energy control: influence of the electrical factor on chronic stimulation threshold. Pacing Clin Electrophysiol 2000; 23: 1359–64.[CrossRef][Medline]

[9] Simeon L, Duru F, Fluri M, Jenzer HR, Rahn M, Candinas R. The impact of automatic threshold tracking on pulse generator longevity in patients with different chronic stimulation thresholds. PEACE Investigators. Pacing Clin Electrophysiol 2000; 23: 1788–91.[Medline]

[10] Schuchert A, Vojtk J, Liu B, Kolk R, Stammwitz E, Beiras J. Affinity MembraneEX Study Group. Autocapture compatability in patients with the MembraneEX lead and Affinity pulse generators. Europace 2001; 3: 332–5.[Abstract/Free Full Text]

[11] Dohrmann Ml and Goldschlager NF. Myocardial stimulation threshold in patients with cardiac pacemakers: Effect of physiologic variables, pharmacologic agents and lead electrodes. Cardiol Clin 1985; 3: 527–37.[Medline]

[12] Boriani G, Biffi M, Branzi A, Mininno A, Sigliano R. Pacemate Study Group. Benefits in projected pacemaker longevity and in pacing related costs conferred by automatic threshold tracking. Pacing Clin Electrophysiol 2000; 23: 1783–7.[Medline]

[13] Sutton R and Bourgeois I. Cost benefit analysis of single and dual chamber pacing for sick sinus syndrome and atrioventricular block. Eur Heart J 1996; 17: 574–82.[Abstract/Free Full Text]

[14] Barold SS, Stokes K, Byrd CL, McVenes R. Energy parameters in cardiac pacing should be abandoned. Pacing Clin Electrophysiol 1997; 20: 112–21.[CrossRef][Medline]

[15] Parsonnet V. The cost effectiveness of dual chamber pacing. Eur Heart J 1996; 17: 495–6.[Free Full Text]

[16] Ribeiro LPR, Rincon LG, Oliveira BG, Vinha CR, Melatto D, Torres AA, et al. Automatic adjustement of pacing output in the clinical setting. Am Heart J 2004; 147: 127–31.[CrossRef][Web of Science][Medline]

[17] Murray CJ and Lopez AD. Alternative projections of mortality by cause 1990–2020: Global Burden of Disease Study. Lancet 1997; 349: 1498–504.[CrossRef][Web of Science][Medline]

[18] Brunner M, Olschewski M, Geibel A, Bode C, Zehender M. Long term survival after pacemaker implantation. Eur Heart J 2004; 25: 88–95.[Abstract/Free Full Text]

[19] Boriani G, Biffi M, Cameron D, Datteri S, Snell J, Holmstrom N, et al. Atrial evoked response integral for automatic capture verification in atrial pacing. Pacing Clin Electrophysiol 2003; 26: 248–52.[CrossRef][Medline]


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