Abstract
Introduction
A large number of older people receive pacemakers each year but broad population‐based studies that describe complications following pacemaker implantation in this population are lacking.
Methods
We conducted a retrospective cohort study using data from the Australian Government Department of Veterans' Affairs database. The cohort consisted of patients who received a pacemaker from 2005 to 2014. The outcomes were subsequent rehospitalizations for infections, procedure‐related complications, thromboembolism, cardiovascular events (heart failure, myocardial infarction, and atrial fibrillation), and reoperation of pacemaker, and mortality.
Results
There were 10 883 pacemakers recipients, the median age was 86 years (interquartile range 83‐89), 61% were males, and 74% received a dual‐chamber pacemaker. Within 90 days postdischarge, rehospitalizations were occasioned by pacemaker infection in 0.5%, device‐related complications in 1.5%, cerebral infarction in 0.7%, and heart failure in 6% of single‐chamber pacemaker recipients. In dual‐chamber pacemaker recipients rehospitalizations were occasioned by pacemaker infection in 0.4%, septicemia in 0.4%, device‐related complications in 1.2%, cerebral infarction in 0.3%, and heart failure in 3%. Rehospitalizations for pacemaker adjustment occurred in 1.5% of patients. The 90‐day postdischarge mortality was 5% and 3% in patients with single‐ and dual‐chamber pacemaker, respectively.
Conclusion
Rehospitalizations for infection, procedure‐related complications, or thromboembolism occurred in 1% to 2% of patients within 90 days postdischarge, while 10% of single chamber and 7% of dual‐chamber recipients experienced a rehospitalization for a cardiovascular event.
Keywords: complications, mortality, older population, pacemaker implantation, rehospitalization
1. INTRODUCTION
The number of new pacemaker implants has been shown to be increasing worldwide.1 In Australia, this figure has reached 652 per million population in 2013.2 With the aging population, the implant rate is expected to rise further as conduction system diseases are more common with senescent. The complications associated with pacemaker implantations can include infections, stroke, atrial fibrillation, myocardial infarction, heart failure, lead displacement or failure, pneumothorax, and death.3, 4 Reports of the rate of complications from Denmark and USA requiring surgical intervention after pacemaker implantation range from 3% within 3 months to 10% within 6 months.4, 5 A large Dutch prospective cohort study found that the short‐term risk of experiencing a device‐ or procedure‐related complication was 12%.6 There are few observational studies based on real‐world data with large sample sizes that characterize the frequency and type of pacemaker associated postdischarge complications in the older population.7
The aim of this study was to describe the type and frequency of rehospitalizations for complications and mortality after discharge following pacemaker implantations in a population‐based cohort of older patients.
2. METHODS
2.1. Study design, setting, and data source
We conducted a retrospective cohort study using data from the Australian Government Department of Veterans' Affairs (DVA) database. The DVA data contain information on hospital admissions, services, procedures, prescription medicines, and medical devices linked on an individual patient level. In 2014, the database had a treatment population of approximately 233 000 people with a median age of 82 years.
We extracted data on all patients who received a cardiac implantable electronic device (CIED) between 1 January 2005 and 31 December 2014. The hospitalizations for the pacemaker procedures were determined using the Australian Classification of Health Interventions (ACHI) procedure codes enabling classification of procedures into implantations, adjustments, replacements or removals of generators or electrodes. The types of pacemaker were determined using codes from the Australian Government's Prosthesis List,8 which contains unique billing codes for individual devices enabling accurate identification of the CIEDs that the patients received (billing codes are captured in the DVA data). Hospital diagnoses were determined using the International Classification of Diseases, 10th revision, Australian Modification (ICD‐10‐AM).
The study has been approved by the University of South Australia and the Australian Government DVA human research ethics, both institutional ethics committees.
2.2. Study cohort selection
Patients were included in this study if they had full entitlement benefits so that the DVA provided funding for all clinically necessary healthcare needs. This was done to be able to identify the type of CIED based on payment for the device.
Patients who had a pacemaker procedure between 1 January 2005 and 31 December 2014 (ACHI block codes 648‐656) were identified and the first procedure selected. To ensure that a CIED was not already present at the first hospitalization, patients whose principal hospital diagnosis included adjustment of cardiac device (ICD‐10‐AM Z45.0) or complications related to cardiac devices (ICD‐10‐AM T82.1, T82.7‐T82.9) were excluded as were patients where there was a record of procedure codes for generator or electrode replacement or removal (ACHI block codes 654‐656).
Identification of patients who received pacemakers were ascertained by matching device billing codes associated with the procedures in the hospital records with billing codes in the Australian Government's Prosthesis List. Prior to 2008, ACHI procedure codes distinguished between implantation of single‐ and dual‐chamber pacemakers; however, thereafter there was no such distinction so determining whether the patients had received single‐ or dual‐chamber pacemakers was ascertained by the description of the pacemaker associated with the billing code. Patients who died during the index hospitalization were excluded from follow‐up as were patients who underwent a concomitant cardiovascular procedure (ACHI block codes 600‐693). This was done to ensure that the complications associated with another cardiac procedure were not attributed to the pacemaker implantation procedure.
2.3. Complications
The main outcomes of interest were rehospitalizations for complications and mortality following discharge from hospital after pacemaker implantation.
A list of ICD‐10‐AM diagnosis codes indicative of complications associated with pacemaker implantations was compiled from the existing literature4, 6, 9 and clinical knowledge. The identified codes were classified into: infection‐related, procedure‐related, thromboembolic, and cardiovascular events (heart failure, myocardial infarction, other acute ischaemic heart diseases [IHD], and atrial fibrillation) (Supporting Information Table S1). For each patient, hospitalizations containing a principal diagnosis of the complications were reported considering that the principal diagnosis constituted the condition that chiefly occasioned the admission. If a patient was hospitalized more than once with the same principal diagnosis, only one encounter was recorded. Rehospitalizations for adjustment and reoperation of the pacemaker were determined by records of hospital diagnosis coded with ICD‐10‐AM Z45.01 (replacement, checking and testing of the generator) and ACHI procedure codes for replacement, adjustment or removal of pacemaker generator or leads. Rehospitalizations for each type of complication and mortality were assessed at 30 and 90 days following discharge from hospital after pacemaker implantation. Follow‐up ceased if patients had device reoperations or other cardiovascular procedures. The end of study was 30 June 2015; all patients were followed until death, reoperation of cardiac device, other cardiovascular procedure or otherwise for at least 90 days.
2.4. Covariates
The patients' age and gender at the index hospitalization were extracted from the data. The indication for hospitalization for implantation of the pacemaker was determined by principal and secondary diagnoses codes (ICD‐10‐AM) associated with hospitalization. Chronic disease burden and types of co‐morbid conditions over 6 months prior to hospitalization were examined by RxRisk‐V, a prescription‐based comorbidity measure (Table S2).10 Cardiovascular procedures occurring 6 months prior to hospitalization were identified by ACHI block codes 600‐693 in the extracted data of hospitalizations for each patient.
2.5. Statistical analysis
All analyses were conducted separately for single‐chamber and dual‐chamber pacemaker cohorts. Descriptive statistics including medians, interquartile ranges, frequencies, and proportions were used to describe the study cohort at baseline and 30 and 90 days mortality and postdischarge complications. SAS 9.4 software (SAS Institute Inc., Cary, NC, USA) was used for all analyses.
3. RESULTS
The study cohort consisted of 10 883 patients who were de novo pacemaker recipients during the study period, had no concomitant cardiovascular procedures, and who were discharged alive from hospital.
Baseline characteristics are presented in Table 1. The most common type of pacemaker implanted was dual‐chamber pacemaker (74%). Patients who received single‐chamber pacemakers had a median age of 87 years, 66% were male and had a median of six co‐morbidities. Patients with dual‐chamber pacemakers had a median age of 86 years, 59% were male, and had a median of five comorbidities. The proportions of patients who received treatment for hypertension, IHD, and hyperlipidaemia were high in both groups. The most prevalent diagnosis in patients with single‐chamber pacemakers was atrial fibrillation or flutter (76%), while for patients who received dual‐chamber pacemakers, the most prevalent diagnosis was atrioventricular block (39%).
Table 1.
Baseline characteristics of the study population
| Patients | Single chamber (N = 2787) | Dual chamber (N = 8096) | P value |
|---|---|---|---|
| Males, n (%) | 1850 (66%) | 4781 (59%) | <0.001 |
| Age, median (IQR), years | 87 (84‐90) | 86 (82‐89) | <0.001 |
| Age groups, n (%) | |||
| <75 | 93 (3%) | 516 (6%) | <0.001 |
| 75‐84 | 854 (31%) | 2945 (36%) | — |
| 85+ | 1840 (66%) | 4635 (57%) | — |
| Number of co‐morbidities, n (%) | |||
| 0 | 52 (2%) | 219 (3%) | <0.001 |
| 1‐4 | 849 (30%) | 2766 (34%) | — |
| 5‐7 | 1223 (44%) | 3358 (41%) | — |
| ≥8 | 663 (24%) | 1753 (22%) | — |
| Median number of co‐morbidities (IQR) | 6 (4‐7) | 5 (4‐7) | <0.001 |
| Co‐morbidities medication treateda, n (%) | |||
| Diabetes | 336 (12%) | 1045 (13%) | 0.2 |
| Hypertension | 1426 (51%) | 4609 (57%) | <0.001 |
| Congestive heart failure | 1150 (41%) | 1877 (23%) | <0.001 |
| Hyperlipidaemia | 1340 (48%) | 4460 (55%) | <0.001 |
| Ischaemic heart disease | 1451 (52%) | 4267 (53%) | 0.5 |
| Anticoagulants use | 1399 (50%) | 1583 (20%) | <0.001 |
| Antiplatelet agents use | 1116 (40%) | 4116 (51%) | <0.001 |
| Arrhythmia diagnoses (ICD‐10‐AM) at index hospitalization, n (%) | |||
| Atrioventricular block (I44) | 472 (17%) | 3126 (39%) | <0.001 |
| Sick sinus disease (I49.5)b | 177 (6%) | 1683 (21%) | <0.001 |
| Atrial fibrillation or flutter (I48) | 2118 (76%) | 1859 (23%) | <0.001 |
| Syncope and collapse (R55) | 326 (12%) | 1240 (15%) | <0.001 |
| Abnormalities of heart beat (R00) | 624 (22%) | 1371 (17%) | <0.001 |
| Atrioventricular block and atrial fibrillation | 253 (9%) | 396 (5%) | <0.001 |
| Sick sinus syndrome and atrial fibrillation | 268 (10%) | 786 (10%) | 0.9 |
| Median length of stay (IQR), days | 3 (1‐7) | 3 (1‐6) | 0.7 |
| Prior cardiovascular procedure within 6 months | 48 (1.7%) | 187 (2.3%) | 0.07 |
Abbreviations: ICD‐10‐AM, International Classification of Diseases, 10th revision, Australian Modification; IQR, interquartile range.
For a list of other co‐morbidities, see Table S2A.
People with a diagnosis of sick sinus disease without atrioventricular block or atrial fibrillation diagnosis at index hospitalization.
3.1. Single‐chamber pacemakers
Altogether 795 (29%) patients experienced a hospitalization within 90 days postdischarge. There were 190 patients (6.8%) who experienced 201 rehospitalizations for the prespecified complications within 30 days postdischarge, and 361 patients (13%) who experienced 421 rehospitalizations for complications within 90 days postdischarge. Table 2 presents the number and proportions of patients with rehospitalizations for specific complications within 30 and 90 days postdischarge following a single‐chamber pacemaker implantation. The majority of the rehospitalizations were due to cardiovascular events, occurring in 126 (4.5%) patients within 30 days and 267 (9.7%) patients within 90 days. When only considering rehospitalizations due to infection, procedure‐related and thromboembolic complications, 70 patients (2.5%) had at least one rehospitalization within 30 days and 112 patients (4%) had at least one rehospitalization within 90 days postdischarge. The most frequent rehospitalizations for infection were due to the pacemaker, with 0.5% of patients being rehospitalized within 90 days for this complication. Of procedure‐related rehospitalizations, the most frequent diagnoses were mechanical and other cardiac device‐related complications, occurring in 1.5% of patients. The most common thromboembolic event was cerebral infarction occurring in 0.7% of patients within 90 days. Rehospitalizations for adjustment of the pacemaker occurred in 0.8% of patients within 30 days and in 1.5% of patients within 90 days postdischarge.
Table 2.
Rehospitalizations for complications in single‐chamber pacemaker recipients 30 and 90 days postdischarge (type of complication defined by ICD‐10 code)
| Single chamber (N = 2787) | Principal diagnoses | |
|---|---|---|
| 30 days | 90 days | |
| Infection‐related rehospitalization, n (%) | ||
| Septicaemia | 2 (0.07%) | 10 (0.36%) |
| Endocarditis | 0 (0%) | 1 (0.04%) |
| Postoperative wound infection | 4 (0.14%) | 8 (0.29%) |
| Infection due to cardiac device | 6 (0.22%) | 13 (0.47%) |
| Procedure‐related rehospitalization, n (%) | ||
| Cardiac tamponade | 0 (0%) | 1 (0.04%) |
| Postprocedural disorders of circulatory system | 4 (0.14%) | 5 (0.18%) |
| Pneumothorax | 0 (0%) | 0 (0%) |
| Mechanical complication of CIED | 14 (0.5%) | 22 (0.79%) |
| Complications of cardiac devices | 17 (0.61%) | 20 (0.72%) |
| Thromboembolism, n (%) | ||
| Transient cerebral ischaemic attack | 6 (0.22%) | 7 (0.25%) |
| Pulmonary embolism | 1 (0.04%) | 5 (0.18%) |
| Cerebral infarction | 14 (0.5%) | 19 (0.68%) |
| Stroke, not specified as hemorrhage or infarction | 4 (0.14%) | 6 (0.22%) |
| Atrial embolism and thrombosis | 0 (0%) | 0 (0%) |
| Phlebitis and thrombophlebitis | 2 (0.07%) | 4 (0.14%) |
| Other venous embolism and thrombosis | 1 (0.04%) | 1 (0.04%) |
| Cardiovascular events, n (%) | ||
| Heart failure | 65 (2.33%) | 166 (5.96%) |
| Myocardial infarction/acute ischaemic heart disease | 16 (0.57%) | 20 (0.72%) |
| Atrial fibrillation | 45 (1.61%) | 81 (2.91%) |
| Adjustment/reoperation, n (%) | 23 (0.8%) | 41 (1.5%) |
| Adjustment/reoperation including lead, n (%) | 19 (0.7%) | 30 (1.1%) |
Abbreviations: CIED, cardiac implantable electronic device; ICD, International Classification of Diseases.
Overall 2% of patients (n = 55) died within 30 days and 5.2% (n = 144) within 90 days postdischarge. Considering only deaths that occurred in conjunction with rehospitalizations for one of the prespecified complications, 17% (15/90) of those who had a rehospitalization within 30 days died, and 9% (32/361) of those who had a rehospitalization within 90 days died. Figure 1 presents the proportion of patients who died or had rehospitalizations within 30 and 90 days postdischarge with infection, procedure, thromboembolism, and cardiovascular‐related principal diagnoses.
Figure 1.
Single‐chamber pacemakers: proportion of recipients who died or were rehospitalized for complications within 30 and 90 days postdischarge
3.2. Dual chamber pacemakers
Altogether 2068 (26%) patients experienced a hospitalization within 90 days postdischarge. There were 422 patients (5.2%) who experienced 452 rehospitalizations for prespecified complications within 30 days postdischarge and 755 patients (9.3%) who experienced 960 rehospitalizations for complications within 90 days postdischarge. Table 3 presents the number and proportions of patients with rehospitalizations for specific complications within 30 and 90 days postdischarge following a dual‐chamber pacemaker implantation. When only considering rehospitalizations due to infection, procedure, and thromboembolic complications, 116 patients (2%) had at least one rehospitalization within 30 days and 269 patients (3.3%) had at least one rehospitalization within 90 days.
Table 3.
Rehospitalizations for complications in dual‐chamber pacemaker recipients 30 and 90 days pots discharge (type of complication defined by ICD‐10 code)
| Dual chamber (N = 8096) | Principal diagnoses | |
|---|---|---|
| 30 days | 90 days | |
| Infection‐related rehospitalization, n (%) | ||
| Septicaemia | 16 (0.2%) | 29 (0.36%) |
| Pericarditis | 0 (0%) | 2 (0.02%) |
| Endocarditis | 0 (0%) | 0 (0%) |
| Postoperative wound infection | 8 (0.1%) | 10 (0.12%) |
| Infection due to cardiac device | 14 (0.17%) | 30 (0.37%) |
| Procedure‐related rehospitalization, n (%) | ||
| Haemopericardium | 1 (0.01%) | 1 (0.01%) |
| Pericardial effusion (non‐inflammatory) | 5 (0.06%) | 7 (0.09%) |
| Cardiac tamponade | 2 (0.02%) | 4 (0.05%) |
| Postprocedural disorders of circulatory system | 6 (0.07%) | 7 (0.09%) |
| Pneumothorax | 6 (0.07%) | 6 (0.07%) |
| Shock during or due to a procedure | 1 (0.01%) | 1 (0.01%) |
| Accidental puncture and laceration during a procedure | 1 (0.01%) | 1 (0.01%) |
| Disruption of operation wound | 1 (0.01%) | 2 (0.02%) |
| Mechanical complication of CIED | 42 (0.52%) | 71 (0.88%) |
| Complications of cardiac devices | 31 (0.38%) | 36 (0.44%) |
| Thromboembolism, n (%) | ||
| Transient cerebral ischaemic attack | 11 (0.14%) | 25 (0.31%) |
| Pulmonary embolism | 9 (0.11%) | 18 (0.22%) |
| Cerebral infarction | 14 (0.17%) | 21 (0.26%) |
| Stroke, not specified as hemorrhage or infarction | 6 (0.07%) | 13 (0.16%) |
| Atrial embolism and thrombosis | 0 (0%) | 0 (0%) |
| Phlebitis and thrombophlebitis | 0 (0%) | 5 (0.06%) |
| Other venous embolism and thrombosis | 2 (0.02%) | 2 (0.02%) |
| Cardiovascular events, n (%) | ||
| Heart failure | 118 (1.46%) | 247 (3.05%) |
| Myocardial infarction/acute ischaemic heart disease | 40 (0.49%) | 78 (0.96%) |
| Atrial fibrillation | 118 (1.46%) | 220 (2.72%) |
| Adjustment/reoperation, n (%) | 65 (0.8%) | 115 (1.4%) |
| Adjustment/reoperation including lead, n (%) | 53 (0.7%) | 87 (1.1%) |
Abbreviations: CIED, cardiac implantable electronic device; ICD, International Classification of Diseases.
Infection due to the pacemaker and septicemia were the two most common reasons for infection‐related rehospitalizations, and 0.4% of patients were rehospitalized within 90 days for either of these complications. Of procedure‐related rehospitalizations, the most frequent diagnoses were mechanical and other cardiac device‐related complications, occurring in 1.3% of patients within 90 days. The most common thromboembolic events were cerebral infarction and transient ischaemic attack, occurring within 90 days in 0.3% of patients for either of these complications. Rehospitalizations for adjustment of the pacemaker occurred in 0.8% of patients within 30 days and in 1.4% of patients within 90 days postdischarge.
Overall 0.9% of patients (n = 76) died within 30 days and 2.6% (n = 208) within 90 days. Considering only deaths that occurred in conjunction with rehospitalizations for one of the prespecified complications, 4.5% (19/422) of those who had a rehospitalization within 30 days died, and 6% (45/755) of those who had a rehospitalization within 90 days died. Figure 2 presents the proportion of patients who died or had rehospitalizations within 30 and 90 days postdischarge with infection, procedure, thromboembolism, and cardiovascular‐related principal diagnoses.
Figure 2.
Dual‐chamber pacemakers: proportion of recipients who died or were rehospitalized for complications within 30 and 90 days postdischarge
4. DISCUSSION
Within 90 days of discharge, rehospitalizations for infection, procedure‐related complications, or thromboembolism occurred in 1% to 2% of single‐ and dual‐chamber pacemaker recipients, while 10% of single chamber and 7% of dual‐chamber recipients experienced a rehospitalization for a cardiovascular event. Rehospitalizations for pacemaker adjustment occurred in 1.5% of patients, most of these included lead adjustment. The overall 90‐day postdischarge mortality was 5% and 3% in patients with single‐ and dual‐chamber pacemaker, respectively.
Other studies have also found infection or procedure‐related complications at similar levels as suggested by our study.5, 6, 11, 12, 13, 14, 15 However, comparison of our results with other studies is challenged by that the reported risks of complications following pacemaker insertions differ according to study cohort characteristics, outcome measures, and length of follow‐up. In one registry‐based study with more than 33 000 initial and replacement pacemaker procedures in patients with an average age of 75 years, 1% of patients experienced tamponade, hematoma, or pneumothorax and 0.6% experienced an infection within 30 days of pacemaker implantation.16 Another study, where pacemaker implantation complications were defined as an event that required surgical intervention, reported that in 3% of patients with an average age of 72 years complications occurred within 3 months of implantation.5 In a Danish registry‐based study, 6.9% of single‐chamber and 8.9% of dual‐chamber pacemaker recipients experienced complications over a period of 6 months, ranging from major complications requiring reinterventions to minor complications that were treated conservatively.4 A recent study reports 30‐day readmission rates of 6% and 11% in single‐chamber and dual‐chamber pacemaker recipients, respectively, where heart failure was the most common cardiac etiology.17
Most studies do not distinguish between complications occurring in‐hospital and those occurring following discharge. As we did not examine in‐hospital complications, this may be the reason that the frequency of some complications such as tamponade and pneumothorax was lower than that found in other studies.5, 12, 16, 18 This may also be the reason that we did not find a difference in rehospitalizations for adjustment and reoperation procedures between single‐ and dual‐chamber recipients. In other studies, in‐hospital pacemaker implantation associated complications have been found to be higher in dual than in single‐chamber pacemaker procedures.19, 20 Furthermore, because we only considered rehospitalizations with principal diagnosis for the prespecified complications, some complications may not have been captured. In our study, 1747 (16%) patients were rehospitalized within 90 days with principal diagnoses that were different to our prespecified complications, some of these hospitalizations contained secondary diagnoses codes with the prespecified complications.
Few studies have reported complications of pacemaker implantations in the older population.7 One study of in‐hospital patients aged 80 years or older, found that 1.2% of patients died while in hospital and 6.2% had an in‐hospital complication following the procedure (obtained by recalculation of the reported data).7 Another study of 149 patients with median age 86 years reported 5.4% of patients were rehospitalized within 30 days after pacemaker implantations, with 1.3% of patients rehospitalized with cerebrovascular events.21 In a study of 481 patients, 80 years and older, 10% of patients had developed cardiovascular, traumatic, pocket, or lead‐related complications within 2 months of pacemaker insertion.22 In our study, 1.5% of single‐chamber recipients and 1% of dual‐chamber recipient experienced rehospitalization for thromboembolism within 90 days. This is higher than reported elsewhere4 and may be due to high median age in our study cohort and also the high proportion of patients with a diagnosis of atrial fibrillation.
Dual‐chamber pacemakers are recommended over single‐chamber pacemakers to avoid pacemaker syndrome which may have a deleterious effect on the quality of life.9 Single‐chamber pacemakers have been recommended for the very old (over 85 years), in patients with high comorbidity burden, and in those in permanent atrial arrhythmia.9, 23 This is consistent with our findings where patients with single chamber were older and had higher comorbidity burden than patients with dual‐chamber pacemakers. Thus the potential for preferential choice of treatment makes comparison of adverse events in recipients of single‐ and dual‐chamber pacemaker prone to bias; hence, we did not compare the outcomes in the two pacemaker groups in this study. Methods such as propensity scores that deal with confounding by indication exist; however, this method does not protect against confounding due to unmeasured variables. Further studies are needed to examine methods to address confounding by indication when comparing types of pacemaker therapies using real‐world data.
The major strength of this study is the quality of the data source. The DVA health claims data are comprehensive due to the DVA services payments. The data contain information on hospital admissions, services, procedures, prescription medicines, and medical devices, which enable determination of rehospitalizations with associated procedures and diagnoses following pacemaker implantation at an individual level.
4.1. Limitations
There are several limitations of using an administrative health claims database: one is the lack of specific clinical information related to the pacemaker such as pacing mode and lead location. Another limitation is the deficiencies in the ICD‐10 code descriptions to provide comprehensive clinical information of the complications. Furthermore, we cannot determine the extent to which misclassification and coding errors may be present. Missing data were also a limitation of our study. In our study cohort, 11% of the procedure codes had no billing codes attached so we were not able to ascertain the type of pacemaker that those patients received. The reason for the lack of billing codes was that the patients were operated in public hospitals and the DVA was not billed for the procedures. However, this is unlikely to bias the results as there is no reported difference in the outcome in public and private hospitals after pacemaker implantations in Australia.24
5. CONCLUSION
By using a comprehensive administrative claims database, we were able to describe the types and frequency of rehospitalizations for complications occurring postdischarge in an older population of real‐world pacemaker recipients. Older patients are often underrepresented in controlled clinical trials,25 thus results from these trials may not be applicable to the older population. Observational cohort studies using real‐world data such as ours may therefore contribute to a better understanding of complications associated with pacemaker implantation in this growing population.
CONFLICTS OF INTEREST
P.S. reports having served on the advisory board of Biosense‐Webster, Medtronic, St Jude Medical, Boston Scientific and CathRx. P.S. reports that the University of Adelaide has received on his behalf lecture and/or consulting fees from Biosense‐Webster, Medtronic, St Jude Medical, and Boston Scientific. P.S. reports that the University of Adelaide has received on his behalf research funding from Medtronic, St Jude Medical, Boston Scientific, Biotronik, and LivaNova. D.H.L. reports having received research funding from St Jude Medical and having received lecture/or consulting fees from St Jude Medical, Boehringer Ingelheim, and Pfizer. None of the other authors report conflicts of interest that are directly relevant to the content of this study.
AUTHOR CONTRIBUTIONS
M.H.G. contributed to the conception, design, analysis, and interpretation of data and drafting of the manuscript. N.L.P., M.C.S.I., S.S., P.S., D.H.L., and E.E.R. contributed to design, analysis, and interpretation of data and revising it critically for important intellectual content. All authors have given final approval of manuscript being submitted.
Supporting information
Table S1. ICD‐10‐AM prespecified diagnoses codes for complications. ICD‐10‐AM, International Classification of Diseases, 10th revision, Australian Modification.
Table S2. Co‐morbidities based on RxRisk‐V.
ACKNOWLEDGMENTS
We acknowledge the support of the data custodian, the Australian Government DVA, which provided data for the conduct of this study. The work was supported by an Australian Government National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Post‐Marketing Surveillance of Medicines and Medical Devices grant (GNT1040938). E.E.R. was supported by NHMRC GNT1110139. P.S. was supported by a Practitioner Fellowship from the NHMRC and by the National Heart Foundation of Australia. D.H.L. was supported by the Robert J. Craig Lectureship from the University of Adelaide.
Gillam MH, Pratt NL, Inacio MCS, et al. Rehospitalizations for complications and mortality following pacemaker implantation: A retrospective cohort study in an older population. Clin Cardiol. 2018;41:1480–1486. 10.1002/clc.23091
Funding information National Health and Medical Research Council, Grant/Award Number: 10409381110139
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Associated Data
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Supplementary Materials
Table S1. ICD‐10‐AM prespecified diagnoses codes for complications. ICD‐10‐AM, International Classification of Diseases, 10th revision, Australian Modification.
Table S2. Co‐morbidities based on RxRisk‐V.