TY - JOUR
AU - Maisel, William H.
AB - ContextDespite there being millions of pacemaker and implantable cardioverter-defibrillator (ICD) generator implants worldwide, little is known about device reliability.ObjectivesTo perform a meta-analysis of prospective pacemaker and ICD registries to determine annual rates of pacemaker and ICD malfunction and to identify trends in these rates.Data SourcesMEDLINE (January 1966 to April 2005), the Cochrane Central Register of Controlled Trials (through second quarter 2005), the Cochrane Database of Systematic Reviews (through second quarter 2005), and a bibliographic review of secondary sources. Search terms included pacemaker, artificial; defibrillators, implantable; registries; performance; and malfunction.Study SelectionEligible registries were prospective; reported the number of patients with pacemaker, ICD, or both; and allowed determination of the annual number of device malfunctions. Of 1007 references screened, 3 registries meeting the selection criteria were identified and included 2.1 million pacemaker person-years and 14 821 ICD person-years of observation.Data ExtractionIncluded the annual number of patients with pacemakers and ICDs at risk of device failure and the annual number of generator malfunctions (1983-2004 for pacemakers, 1988-2004 for ICDs). A device malfunction was defined as an integral component failure that required device explantation prior to reaching elective replacement. Failures of pacemaker and ICD electrodes were not included in the study.Data SynthesisThere were 2981 pacemaker and 384 ICD generator malfunctions. Pacemaker reliability improved markedly during the 1980s (Pfor trend <.001) and the pacemaker malfunction rate remained low during the remainder of the study. Implantable cardioverter-defibrillator reliability improved during the first 10 study years (Pfor trend <.001). From 1998-2002, however, the ICD malfunction rate increased more than 4-fold (Pfor trend <.001), before decreasing substantially in the latter 2 years of the study. Overall, the mean (SE) annual ICD malfunction rate was about 20-fold higher than the pacemaker malfunction rate (26.5 [3.8] vs 1.3 [0.1] malfunctions per 1000 person-years, P<.001). Battery malfunctions were the most common cause of device failure.ConclusionsPacemaker reliability has improved markedly. In contrast, after more than a decade of improving device reliability, the ICD malfunction rate transiently increased before experiencing substantial reductions in the latter 2 study years. Whether increasing device sophistication accounts for the observed decrease in reliability is not known. Continued monitoring of pacemaker and ICD performance is required.Recently, questions about the safety and reliability of permanent pacemaker and implantable cardioverter-defibrillator (ICD) generators have gained national attention.Surprisingly, despite millions of implants worldwide and increasingly broad indications for their use, little is known about the overall performance of these devices.Previous reports have documented occasional device failures, hundreds of thousands of advisory devices, and an increasing rate of recall.Whether increasing device complexity has been accompanied by a decrease in device reliability is not known.Manufacturers are required to report to the US Food and Drug Administration (FDA) any device malfunction that causes, or could cause, harm to a patient.However, because of underreporting of device malfunctions by clinicians, it can be difficult to determine the true incidence of device malfunction.Several pacemaker and ICD registries have monitored pacemaker and ICD performance, although most are limited by their small size, voluntary nature, or lack of knowledge regarding the number of at-risk patients.This has limited accurate determination of pacemaker and ICD malfunction rates.This study was undertaken to overcome these limitations. Specifically, a meta-analysis of all relevant pacemaker and ICD registries was performed to determine pacemaker and ICD malfunction rates and to identify trends in these rates.METHODSAll registries involving pacemaker and ICD generators were identified using a 2-level search strategy. First, public domain databases including MEDLINE (January 1966 to April 2005), the Cochrane Central Register of Controlled Trials (through second quarter 2005), and the Cochrane Database of Systematic Reviews (through second quarter 2005) were searched for English-language articles using the keywords pacemaker, artificial; defibrillators, implantable; registries; performance; and malfunction. Then references from relevant articles were searched.To be included in the study, registries had to be prospective, report the precise number of patients who had received a pacemaker or an ICD implant, allow determination of the annual number of device malfunctions, and involve at least 100 devices. A Quality of Reporting of Meta-analysis (QUOROM)flow diagram of the registry selection process is presented as Figure 1.Figure 1.A Flow Diagram of the Study Selection ProcessThe analytic set comprised 3 registries selected from among 1007 articles originally identified by the search strategy.A device was only considered to have malfunctioned if it suffered a failure that required device explantation prior to reaching elective replacement. Only malfunctions due to integral component failure (hardware or firmware abnormalities) were counted. Specifically, device replacements for other reasons, such as oversensing, undersensing, normal battery depletion, or upgrade of system (from single chamber to dual chamber, or from pacemaker to ICD, for example) were not included. Electrode abnormalities were not included.All qualifying registries were assessed for completeness of follow-up and objectivity of the outcome (malfunction) assessment.Statistical AnalysisFor each registry, data regarding the annual number of “at risk” patients and the annual number of device malfunctions were used to generate annual malfunction rates. When the precise number of person-years at risk was not available, person-years were calculated based on either age at implant and age-based life expectancy of patients who received pacemaker or an ICDor registry device life-table survival analysis.Study-specific annual estimates were combined using inverse variance-weighted averages of logarithmic ratios in both fixed- and random-effects models. Between-study heterogeneity was analyzed by means of standard &khgr;2tests, with P≤.10 deemed statistically significant. When no significant statistical heterogeneity was identified, the fixed-effect estimate was used preferentially as the summary measure.Meta-regression to assess explanations for between-study heterogeneity was considered, then abandoned, due to the small number of registries in the final analyses and the lack of significant between-study variance detected by the &khgr;2test. A priori, trends were assessed over each 5-year interval and over the duration of the study. After identifying the registries but before extracting the data, it was decided to report pacemaker reliability beginning in 1983 and ICD reliability beginning in 1988. Malfunction rates are reported per 1000 person-years. The tand &khgr;2tests were used to compare continuous and discrete outcomes, respectively. Mantel-Haenszel &khgr;2tests were used to assess for trends.Sensitivity analyses were performed to assess the contribution of each study to the pooled estimate by excluding individual registries one at a time and recalculating the estimates for the remaining studies. Publication bias was assessed graphically using a funnel plot and mathematically using an adjusted rank-correlation test, according to the method of Begg and Mazumdar.Analyses were conducted using STATA statistical software, version 8.2 (StataCorp, College Station, Tex) and SAS statistical software, version 9.1 (SAS Institute Inc, Cary, NC). A 2-tailed Pvalue of less than .05 was interpreted as being statistically significant.RESULTSRegistriesOf 10 prospective registries initially identified by the search strategy, 3 satisfied the predefined criteria: the Bilitch Registry,the Danish Pacemaker and ICD Register,and the UK Pacemaker and ICD Registry(Table 1).Table 1.Registries Selected for Pacemaker and Implantable Cardioverter-Defibrillator Meta-analysisRegistry NameRegistry Years (Years Contributing to Meta-analysis)*No. of Devices†Devices ImplantedDevice Person-yearsDevice MalfunctionsPacemakerICDPacemakerICDPacemakerICDPacemakerICDBilitch Registry1974-1993 (1983-1993)1982-1993 (1988-1993)227863520264036014161250Danish Pacemaker and ICD Register1982-2004 (1994-2004)1989-2004 (1994-2004)4474531141447698807319134UK Pacemaker and ICD Registry1977-2004 (1983-2004)1989-2004 (None)408087139991925338NA2501NAAbbreviations: ICD, implantable cardioverter-defibrillator; NA, not available.*Registry years for which data were used to conduct meta-analysis. See “Methods” section for details.†Device person-year and malfunction totals for years included in meta-analysis.The Bilitch Registry monitored the performance of 22 786 pacemaker generators in 16 903 patients from 6 North American centers beginning in 1974 and 3520 ICDs in 2626 patients from 13 North American centers starting in 1982.The registry ended in 1993.The Danish Pacemaker Register began in 1982, incorporated ICDs in 1989, and includes Danish pacemakers and ICD implants from all 14 Danish pacemaker and all 5 Danish ICD implantation centers.The register includes 44 745 pacemakers implanted in 35 827 patients and 3114 ICDs implanted in 2367 patients.Detailed annual malfunction data were available from the Danish Pacemaker and ICD Register for the years 1994-2004. The UK National Pacemaker and ICD Registry includes all implanted pacemakers and ICDs in the United Kingdom and Republic of Ireland.The registry monitored 408 087 pacemaker implants in 322 668 patients from 190 centers from 1977-2004 and 13 999 ICD implants in 11 451 patients from 58 centers from 1989-2004.Although detailed annual ICD malfunction reporting from the UK ICD registry has not been published, annual pacemaker malfunction reporting was available and was used in the meta-analysis for determination of pacemaker reliability.PacemakersPacemaker reliability meta-analysis was based on a total of 2.1 million pacemaker person-years of observation, with the United Kingdom, the Danish, and the Bilitch registries contributing 91.8%, 6.9%, and 1.3%, respectively. Pacemaker malfunctions were observed in 2981 devices during the 22-year period covered by the study. Annual pacemaker malfunction rates ranged from a high of 12.4 malfunctions per 1000 person-years (95% confidence interval [CI], 10.9-13.9 malfunctions per 1000 person-years) in 1983 to a low of 0.7 malfunctions per 1000 person-years (95% CI, 0.3-1.2 malfunctions per 1000 person-years) in 1998 (Figure 2). There was a significant decrease in annual pacemaker malfunction rate from the first to the second 5-year study period (1983-1987 to 1988-1992, P = .009). Although there was some annual variation in pacemaker malfunction rate over the ensuing years, there was no significant trend in annual failure rate between 1992 and 2004. Overall, pacemaker reliability markedly improved during the study (Pfor trend <.001).Figure 2.Pacemaker Malfunction Rates, 1983-2004The annual pacemaker malfunction rates are displayed for the 3 individual registries included in the meta-analysis and for the meta-analysis itself. Pacemaker malfunction rates decreased significantly during the study period. Error bars represent 95% confidence intervals. See “Methods” sections for details.The mean (SE) annual pacemaker malfunction rate was not significantly different between the Bilitch and the UK pacemaker registries during the study years that the 2 registries coexisted (1983-1993; 5.2 [1.2] vs 4.1 [1.3] malfunctions per 1000 person-years; P = .53). Both registries demonstrated a marked reduction in pacemaker failure rates and both demonstrated similar overall trends in device performance (Figure 2). For the years 1994-2004, when data from both the Danish and the UK registries were available, the mean (SE) annual pacemaker malfunction rate was higher, albeit not statistically significantly, for the Danish vs the UK registry (2.2 [0.7] vs 0.8 [0.1] malfunctions per 1000 person-years, P = .07). In reality, only in 2001 were the pacemaker malfunction rates markedly different (Figure 2). During this year, the Danish registry reported an unusually high number of premature battery failures predominantly related to one model from one manufacturer (Vigor pacemaker, Guidant Corp, Indianapolis, Ind). The fixed-effects estimate (rather than the random-effects estimate) was used for 2001 and believed to be a more accurate representation of the true incidence of pacemaker malfunction (Figure 2). The size of the Danish registry (one tenth the number of person-years compared with the UK registry in 2001) may make it more susceptible to sampling variations in individual device performance.Implantable Cardioverter-DefibrillatorsImplantable cardioverter-defibrillator malfunction rates are based on a total of 14 821 person-years of observation: 59.4% from the Danish and 40.6% from the Bilitch registries. The ICD malfunctions were observed in 384 devices during the 17-year study period. Annual ICD malfunction rates ranged from a high of 52.5 malfunctions per 1000 person-years (95% CI, 35.8-69.2 malfunctions per 1000 person-years) in 1989 to a low of 5.6 malfunctions per 1000 person-years (95% CI, 1.6-15.5 malfunctions per 1000 person-years) in 1998 (Figure 3). Although there was a significant decrease in the ICD malfunction rate over the course of the study (Pfor trend <.001), the improvement in device reliability primarily occurred during the first 10 study years (Pfor trend <.001). Indeed, there was a significant decrease in the annual ICD malfunction rate during the first 5-year study period (1988-1992, Pfor trend <.001) and during the second 5-year study period (1993-1997, Pfor trend <.001). In contrast, during the third 5-year period (1998-2002), the ICD malfunction rate significantly increased from 5.6 malfunctions per 1000 person-years (95% CI, 1.6-15.5 malfunctions per 1000 person-years) in 1998 to a peak of 26.3 malfunctions per 1000 person-years (95% CI, 18.1-37.5 malfunctions per 1000 person-years) in 2001 (Pfor trend <.001, Figure 3). Device reliability improved markedly during the latter 2 years of the observation period. The lowest ICD malfunction rates were observed from 1996-1999 and again in 2003-2004.Figure 3.Implantable Cardioverter-Defibrillator Malfunction Rates, 1988-2004The annual implantable cardioverter-defibrillator (ICD) malfunction rates are shown. The annual rate of ICD malfunction decreased from 1988 to 1998 and increased significantly between 1998 and 2002 before experiencing a reduction in the latter study years. Data from the Bilitch Registry (1988-1993) and the Danish Register (1994-2004) contributed to this analysis. Error bars represent 95% confidence intervals. See “Results” section for details.Comparison of Pacemaker and ICDMalfunction Rates.The number of pacemaker person-years of observation exceeded the number of ICD person-years of observation during the study period by more than 100-fold. Yet the total number of pacemaker malfunctions was only 7.8 times the number of ICD malfunctions. Indeed, during the years for which both pacemaker and ICD annual malfunction rates were available (1988-2004), the mean (SE) annual ICD malfunction rate was about 20-fold higher than the pacemaker malfunction rate (26.5 [3.8] vs 1.3 [0.1] malfunctions per 1000 person-years, P<.001). Even during the years of lowest annual ICD malfunction rate (1996-1999, 2003-2004), ICDs failed more than 9 times as often as pacemakers.Types of Device Malfunctions.Battery malfunctions, most often premature battery failure, were the most common cause of device failure in every registry for both pacemakers and ICDs (Table 2). For pacemakers, an additional 14.3% (95% CI, 9.0%-20.6%) of device malfunctions were due to low or no output states. A number of root causes, however, can masquerade as a battery abnormality including rapid premature battery depletion, electrical short circuits, inappropriate high-current drains, or hermetic seal abnormalities. Miscellaneous other types of device failures, such as programming malfunctions, device header abnormalities, magnetic switch malfunctions, and charge circuit abnormalities (for ICDs) accounted for the majority of the other reported device malfunctions (Table 2).Table 2.Pacemaker and Implantable Cardioverter-Defibrillator Malfunction RatesMalfunctionPacemakerICDNo. (%)*Meta-analysis, % (95% CI)No. (%)*Meta-analysis, %(95% CI)UK RegistryDanish RegisterBilitch RegistryDanish RegisterBilitch RegistryBattery1395 (55.8)131 (41.1)100 (62.1)52.8 (42.3-63.2)104 (77.6)204 (81.6)80.1 (76.0-83.9)No or low output306 (12.2)67 (21.0)16 (9.9)14.3 (9.0-20.6)6 (4.5)01.5 (0.4-9.3)Programming malfunction78 (3.1)11 (3.4)5 (3.1)3.2 (2.6-3.9)000Miscellaneous†278 (11.1)18 (5.6)10 (6.2)7.9 (4.4-12.3)4 (3.0)17 (6.8)5.6 (3.5-8.0)Unspecified444 (17.8)92 (28.8)30 (18.6)21.6 (14.8-29.3)20 (14.9)29 (11.6)12.9 (9.7-16.4)Total2501 (100)319 (100)161 (100)100134 (100)250 (100)100Abbreviations: CI, confidence interval; ICD, implantable cardioverter-defibrillator.*Percentage of column totals may not add to 100% due to rounding.†Includes device header abnormalities, magnetic switch malfunctions, charge circuit abnormalities. See “Methods” section for details.COMMENTAlthough millions of pacemakers and ICDs have been implanted worldwide, surprisingly little is known about their reliability.This study demonstrates that pacemaker reliability improved markedly during the 1980s and that the pacemaker malfunction rate has remained low despite increasing device complexity. In contrast, after a decade of significant improvements in ICD reliability through the late 1990s, the ICD malfunction rate increased more than 4-fold from 1998 through 2002. Notably, however, ICD reliability improved substantially in the latter 2 study years. Overall, the ICD malfunction rate is substantially higher than the pacemaker malfunction rate.Because pacemakers and ICDs are complex medical devices, it is not surprising that they may occasionally malfunction. In fact, hundreds of malfunctions affecting dozens of models have previously been reported.Device malfunctions are not unique to one model or to one manufacturer.Indeed, each major pacemaker and ICD manufacturer has experienced product performance difficulties.Trends in Device PerformancePacemakers experienced impressive reductions in malfunction rates during this study, overall experiencing a 6-fold reduction in the risk of device failure. Most of these reliability improvements were observed during the 1980s at a time when pacemakers underwent rapid technological advances including the introduction of dual-chamber pacing, improved programmability, increased longevity, reduced size, and more comprehensive diagnostics.In addition, pacemaker reliability changed little from 1988 to 2004 despite the advent of additional novel pacing features, such as increased electrogram storage capacity and automatic threshold determination. Pacemakers, therefore, are evidence that significant technological advancements may be achieved without sacrificing device reliability.Implantable cardioverter-defibrillators, like pacemakers, experienced impressive reductions in annual malfunctions rates during the first years of the study. In fact, ICD malfunction rates decreased 10-fold between 1988 and 1998. In contrast to pacemakers, however, ICD malfunction rates increased substantially from 1998 to 2002, suggesting that during this period they became less reliable. A number of novel features were introduced to ICDs in the mid and late 1990s, including dual-chamber sensing and pacing, sophisticated algorithms for arrhythmia detection and treatment, marked increases in device memory, and significant reductions in device size.Whether increasing device sophistication led to the observed decrease in ICD reliability is not known. Although it is reassuring that the ICD malfunction rates for the years 2003 and 2004 are lower, ongoing monitoring of ICD performance is still required.Comparison With Other StudiesIn the United States, manufacturers are required to submit detailed annual reports to the FDA regarding the number of pacemaker and ICD implants and the number and causes of device malfunction.Analysis of these reports from 1990 to 2002 demonstrated trends in pacemaker and ICD performance similar to those observed in this study.Specifically, like this study, the FDA annual report analysis showed an overall improvement in pacemaker reliability, an ICD malfunction rate nadir in the mid to late 1990s, a trend of decreased ICD reliability from 1998 to 2002, and ICD malfunction rate considerably higher than the pacemaker malfunction rate.Although device malfunction reporting to the FDA by physicians and patients is voluntary and subject to substantial underreporting,this study was an analysis of active registries, for which device performance and malfunction reporting were proactively monitored. Therefore, the results are less likely to be affected by malfunction underreporting. Dozens of models from multiple manufacturers were included in these registries. Because all major manufacturers distribute their product internationally, it is not unexpected that device performance from international registries, as in this study, would be similar to that observed in a US–based FDA analysis. Individual manufacturer's product performance could not be analyzed in this study because not all registries annually provided sufficient detail.Types of Device MalfunctionsDevice malfunction was classified according to the physician report and clinical behavior of the device, not on a manufacturer-determined cause-of-device failure. Nevertheless, abnormal device behavior had to be significant enough to result in generator removal to be considered a malfunction. Importantly, lead abnormalities, oversensing or undersensing, and malfunctions that could be overcome with device reprogramming were not included in this study. Only true device malfunctions that required generator replacement were counted.Battery abnormalities were the most common reported cause of device malfunction for both pacemakers and ICDs. These battery abnormalities likely represent a variety of specific malfunctions. For instance, a true battery malfunction or an electrical short circuit could both result in rapid battery depletion and present as premature battery failure. Electrical and battery abnormalities are the most common cause of pacemaker and ICD advisories and malfunctions.Marked reductions in ICD size may account for some of the observed increase in ICD malfunction rate. Specifically, novel battery, capacitor, and circuitry designs have been developed to promote, among other things, size reductions. On occasion, these design changes have led to unanticipated device failures.Although the malfunctions reported in this study were sufficient to warrant device replacement, not all malfunctions are of similar severity. Premature battery depletion, for example, may require premature device replacement but does not necessarily carry the same risk as a sudden unexpected electrical short that may lead to unanticipated catastrophic device failure. Efforts to better categorize and report device failures would allow for more accurate assessment of device performance.Implications of Study FindingsGiven the number of pacemaker and ICD malfunctions, and the transient but notable increase in ICD malfunction rate, ongoing surveillance of pacemaker and ICD performance is clearly required. Active device registries, as used in this study, can provide important insights into device performance trends. Individual device, model, and manufacturer performance may vary from the results reported in this study. The Centers for Medicaid & Medicare Services (CMS) has recently initiated an ICD Registry as a requirement of reimbursement for ICDs implanted for primary prevention. Unfortunately, as currently configured, the CMS ICD registry cannot monitor device performance trends. Efforts to adapt this existing registry for the purpose of actively monitoring pacemaker and ICD performance should be undertaken and could be achieved at relatively little increased expense.Although this study investigated actual device malfunctions, it does not include data on the number of advisory or recalled devices (ie, devices with the potential to malfunction) or the number of devices replaced due to an advisory in the absence of demonstrable malfunction. Pacemaker and ICD advisories and malfunctions have enormous financial implications and have resulted in tens of thousands of device replacements.Increasingly sophisticated device self-monitoring capabilities may allow for more reliable device follow-up in the near future. Automatic checks as well as wireless or Internet-based physician notification schemes may drastically improve routine pacemaker and ICD monitoring of performance. In the meantime, routine pacemaker and ICD office checks remain the best method for monitoring device performance in individual patients. Despite the observed transient increase in the ICD malfunction rate, these devices are clinically proven to reduce mortality in appropriately selected patients. As such, the clinical benefits of the devices far outweigh the risk of malfunction.LimitationsThere are several limitations to this study. Although malfunctions had to result in device replacement in order to be counted, the true clinical implications of these procedures and of device malfunctions that did not require device replacement is unknown. In addition, malfunctions that may have resulted in death are notoriously underreportedand would not have been counted in this study. For device failures, the year of device implant was not known. The malfunction rates in this study represent a patient's risk of device failure in a given year. An individual patient's risk will potentially vary depending on factors that could not be sufficiently evaluated in this study, such as device model and years since implant.Although there were a relatively small number of registries that qualified for the meta-analysis, each was a prospective, active registry. Overall, more than 2 million pacemaker person-years and more than 10 000 ICD person-years of observation were included. Because of the large observational experience and the international nature of the study, it is likely that the results are generalizable to patients with a pacemaker or ICD throughout the world. Individual product performance, however, may vary.ConclusionsThis study of pacemaker and ICD registries demonstrates that the pacemaker malfunction rate decreased markedly during the 1980s and has remained low despite increasing device sophistication, the ICD malfunction rate decreased steadily for a decade beginning in 1988 reaching a nadir in the mid to late 1990s, the ICD malfunction rate increased 4-fold from 1998 to 2002 before experiencing substantial reductions in the latter 2 years of the study, and the ICD malfunction rate is substantially higher than the pacemaker malfunction rate. Continued monitoring of pacemaker and ICD performance is required. Efforts should be directed at improving the reliability of these important devices.Corresponding Author:William H. Maisel, MD, MPH, Cardiovascular Division, Beth Israel Deaconess Medical Center, 185 Pilgrim Rd, Baker 4, Boston, MA 02215 (wmaisel@bidmc.harvard.edu).Author Contributions:Dr Maisel had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.Study concept and design,acquisition of data,analysis and interpretation of data,drafting of the manuscript,critical revision of the manuscript for important intellectual content,statistical analysis,administrative, technical, or material support,and study supervision: Maisel.Financial Disclosures:Dr Maisel is an FDA consultant, although this study was conducted without FDA financial support. There are no additional financial disclosures.Disclaimer:Dr Maisel is the chair of the FDA Circulatory System Medical Devices Advisory Panel. 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TI - Pacemaker and ICD Generator Reliability
JF - JAMA
DO - 10.1001/jama.295.16.1929
DA - 2006-04-26
UR - https://www.deepdyve.com/lp/american-medical-association/pacemaker-and-icd-generator-reliability-KxCOTRTBve
SP - 1929
EP - 1934
VL - 295
IS - 16
DP - DeepDyve
ER -