QJM Advance Access published online on September 27, 2008
QJM, doi:10.1093/qjmed/hcn122
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The patient journey from symptom onset to pacemaker implantation
From the Department of Cardiology, Freeman Hospital, Newcastle upon Tyne NE7 7DN, UK.
Address correspondence to Dr M.S. Cunnington, c/o Dr J.M. McComb, Department of Cardiology, Freeman Hospital, Freeman Road, Newcastle upon Tyne NE7 7DN, UK. email: mike.cunnington{at}ncl.ac.uk
Received 27 June 2008 and in revised form 26 August 2008
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Summary |
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Background: Regional variation in permanent pacemaker (PPM) implantation rates is well described, the reasons for which are unclear. Significant delays to PPM implantation in UK practice were described 20 years ago, but contemporary data are lacking.
Aim: To investigate delays to PPM implantation and their causes.
Design: Prospective observational study in a UK regional pacing centre and its referring district hospitals.
Methods: A total of 95 consecutive patients receiving first PPM implant for bradycardia indications from 1 June 2006 to 31 August 2006 were included. Hospital records from the referring and implanting centres were reviewed to determine the timings of: symptom onset; first hospital contact; documented pacing indication (defined by 2002 ACC/AHA/NASPE guidelines); referral to implanter; and PPM implantation.
Results: Forty-eight patients (51%) were referred for pacing urgently; median delay from symptoms to PPM 15 days (range 0–7332 days). Forty-seven patients (49%) were referred electively; median delay from symptoms to PPM 380 days (range 33–7505 days), P < 0.0001. Twenty-three of the 47 elective patients (49%) had previous hospitalization with symptoms suggestive of bradycardia. Thirty-three of the 95 patients (35%) had a Class I or IIa pacing indication which did not trigger a pacing referral.
Conclusions: There are significant delays to PPM implantation in the United Kingdom, longer in those treated electively than those managed as emergencies. Some delays are due to ‘process’ problems including waiting lists, but a substantial proportion of patients had delays due to failure to refer for pacing once a pacing indication was documented.
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Background |
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Geographic variations in permanent pacemaker (PPM) implantation rates are well described, both in Europe,1 and within England and Wales.2 The reasons for this are not clear, but preliminary investigation suggests that local factors, perhaps prior to referral for pacing, may be important.3 In order to determine what these local factors might be, and how patients are referred for pacing, we investigated the patient journey, from onset of symptoms to PPM implantation, in patients receiving PPMs at a large regional pacing centre.
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Methods |
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Consecutive patients receiving a first PPM at a single large UK implanting centre over a 3-month period from 1 June 2006 to 31 August 2006 were included prospectively. Hospital records from the referring and implanting centres were reviewed to determine the timings of: symptom onset; first hospital contact; documented pacing indication; referral to implanter; and PPM insertion. Previous contacts with secondary care that may have been related to bradycardia were also documented and reviewed.
The 2002 joint ACC/AHA/NASPE (American College of Cardiology/American Heart Association/North American Society of Pacing and Electrophysiology) guidelines for PPM implantation4 were used to define pacing indications. Class I and IIa indications were taken as appropriate triggers for PPM referral. Electrocardiogram (ECG) and clinical data were reviewed by two cardiologists with an interest in pacing. Data did not show a normal distribution and are presented as median and range, with statistical analyses performed using the non-parametric Mann–Whitney test.
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Results |
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Study population
During the 3-month study period, 120 consecutive patients underwent first PPM implantation. Sixteen received PPMs for rate control of atrial fibrillation as part of an ‘ablate and pace’ strategy without a separate indication for bradycardia pacing, and nine received biventricular devices for cardiac resynchronization therapy. These 25 were excluded from further analysis because there was no clear time at which an indication for bradycardia pacing was defined. The 95 remaining patients were included in the analysis.
Forty-eight patients (51%) were referred for pacing urgently, following an emergency hospital admission. These patients were managed as inpatient transfers. The 47 remaining patients were referred electively for pacing as outpatients. The demographic characteristics of urgent and elective patients were similar. Mean age of urgent patients was 75.4 years (range 46–97 years), and of elective patients 74.1 years (range 44–95 years). Twenty-three (48%) urgent patients and 25 (53%) elective patients were males.
Symptoms and ECG diagnosis for both urgent and elective groups are shown in Figures 1 and 2. The proportion of patients with syncope was similarly high in both groups (54% in the urgent group and 53% in the elective group). Patients paced urgently had a higher incidence of complete heart block (50% vs. 11%, P < 0.0005) and lower incidence of second-degree heart block (4% vs. 26%, P = 0.004).
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Delays to PPM implantation
The intervals in the patient journey from symptoms to PPM implantation defined above are shown in Table 1.
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Symptom onset to presentation to secondary care
Timing of first symptom could not be reliably determined for four elective patients and eight patients were asymptomatic. In the remaining 83 patients, the interval from symptom onset to hospital presentation was longer in the elective group, but this did not reach statistical significance. The majority of elective patients (57%) presented to secondary care within 4 weeks of symptom onset. Twenty-three (49%) of the elective group had previously been admitted to hospital with symptoms such as dizziness or syncope that were suggestive of bradycardia, or had symptoms or documentation of bradycardia during inpatient care for other problems.
Secondary care presentation to documentation of pacing indication
This interval was significantly shorter in urgent than elective patients, with 65% of the urgent group having a pacing indication documented within 24 h of hospital presentation. One patient in the elective group who received a PPM but did not satisfy standard implantation criteria was omitted from analyses relating to date of documented pacing indication.
Documentation of pacing indication to referral
Time to referral was significantly shorter in the urgent group than in elective patients. Two patients referred urgently were delayed (by 9 and 11 days) for management of intercurrent medical problems prior to pacing referral being made. The longer delays in both groups were mainly caused by failure to refer once a PPM indication had been documented.
Thirty-three (35%) of the 95 patients in this study had a previous Class I or IIa pacing indication that did not trigger a pacing referral. Eighteen of the 33 ‘missed’ indications occurred whilst patients were taking rate-limiting medication, the reasons for which are shown in Table 2. Ten patients were taking rate-limiting medication for control of previous tachyarrhythmias. The median delay from documented pacing indication to referral for pacing in these patients was 104 (range 6–7330) days.
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Referral to PPM implantation
The interval between pacing referral and PPM implantation was significantly shorter for urgent patients, who were referred using an electronic web-based system to an on-call cardiologist, than elective patients, who were referred in traditional ways. The single patient who waited longer than 2 weeks in the urgent group had intercurrent medical problems precluding pacing. Although the interval from referral to PPM implantation in elective patients was the single longest median delay at 65 days, the range was narrow with no patients experiencing very long delays at this stage. Thirty-two (68%) of the 47 electively paced patients received a PPM within 12 weeks, and none waited longer than 6 months from time of referral.
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Discussion |
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This study demonstrates significant delays at each stage of the patient journey from symptom onset to PPM implantation. These delays are much shorter in patients referred as emergencies than in those referred electively as outpatients. It also shows that the majority of patients who receive permanent pacemakers do so after an emergency admission to hospital. However, emergency admission did not trigger urgent referral for pacing in 15 of the 23 electively paced patients in whom diagnostic criteria were met during or prior to the admission. Some delays are due to ‘process’ problems in the investigation and referral pathway, but a substantial proportion (35%) of patients had delays due to failure to refer for pacing following documentation of a pacing indication.
The only similar study was performed over 20 years ago.5 Mackintosh and Boyle5 described similar delays in permanent pacing, only a third of patients receiving pacemakers within a month of the onset of symptoms and 40% waiting longer than 6 months. Hospital factors were the single biggest contribution to delay (36%). Other causes of delay included patients’ failure to seek medical advice in 25%, failure of primary care to refer in 14%, and to a combination of factors in the remainder. As shown in Table 3, delays to pacing in our contemporary UK cohort show little change compared to 1986 data.
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Potential limitations of this study |
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Our study has not been able to examine possible delays in primary care. However, since the interval from symptom onset to secondary care presentation was short for most patients, and all of the urgent patients and 49% of the elective patients had a hospital admission, delays in secondary care appear to be more significant. Our study has examined the causes of hospital delays in detail, and has demonstrated that indications for pacing are either overlooked, not recognized, or not acted upon in a significant minority of patients.
Pacemaker implantation was the index event in our study population; we have not been able to identify patients with pacemaker indications who have not been referred for pacing, but the inference from our study must be that pacemaker indications are continuing to be overlooked, or are never recognized in some patients, perhaps contributing to the low pacing rates in the United Kingdom. Our study also shows that there are important delays in the process of investigation and referral for pacing, these delays tending to be cumulative.
The diagnosis of pacemaker indications for the purpose of the study was made retrospectively, by chart review and rigid adherence to pacemaker guidelines.4 This has led to a very ‘black and white’ approach, which of course may not reflect clinical practice, particularly in relation to an elderly population with multiple comorbidities. We opted to make a diagnosis of a pacemaker indication regardless of concomitant drug therapy, because there is evidence that stopping rate-limiting therapy does not significantly affect heart block,6 and rate-slowing drugs are often required in patients with atrial arrhythmias, rate control being achieved at the expense of bradycardia. This approach is recognized by the pacemaker guideline in patients with acquired atrioventricular block or sinus node dysfunction,4 but may not be appropriate in patients without tachyarrhythmias. We were of course unable to identify patients in whom an approach of reinvestigating after withdrawal of rate-limiting medication was successful in relieving symptoms without resort to pacing.
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Study implications |
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The implications of this study are 2-fold: first, that the process of investigation and referral of patients between hospitals and departments should be streamlined, which would reduce delays significantly; and second, that those in hospital to whom potential pacemaker patients present (mainly general and care of the elderly physicians) need further help in determining which patients should be referred for pacing. This help may be provided by local education and access to pacemaker guidelines. A brief and simplified summary of some common pacing indications is given in Table 4. Pacing guidelines have recently been updated, with full guidance and excellent pocket-guides accessible online.7–9
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Our data show that it is worth highlighting some pacing indications. In the presence of syncope or significant symptoms consistent with bradycardia, clinically significant evidence of sinus node dysfunction (e.g. heart rate <40/min) is a Class IIa indication even though a clear association between symptoms and bradycardia has not been documented. Similarly, syncope in the presence of bi/trifascicular block in the absence of another likely cause is a Class IIa pacing indication, even when syncope has not actually been documented as due to atrioventricular block. Third-degree and Mobitz II second-degree blocks suggest severe conducting system disease and are Class IIa indications for pacing even in the absence of symptoms or pauses.
Bradycardia in the presence of rate-slowing medication that is required for another indication (such as control of tachyarrhythmias, as that which commonly occurs in sinus node disease with ‘tachy–brady’ syndrome) is perhaps open to a greater degree of individual interpretation. This group were commonly overlooked for pacing in our study, but the guidelines clearly recognize this as a pacing indication.
We hope that highlighting current delays to pacing and raising awareness of simplified pacing guidance will help to increase the recognition of patients who might benefit from this highly effective therapy.
Conflict of interest: M.S.C., C.J.P. and J.M.M. have received financial support from device companies for attending educational meetings. J.M.M. and C.J.P. have received honoraria for speaking from device companies and J.M.M. supervises a research fellow funded by an educational grant from a device company. The other author has declared no conflict of interest.
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References |
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1. Ector H, Vardas P. Current use of pacemakers, implantable cardioverter defibrillators, and resynchronization devices: data from the registry of the European Heart Rhythm Association. Eur Heart J (2007) 9(Suppl. I):I44–9.[CrossRef]
2. Network Devices Survey Group. Pacemakers and implantable defibrillators: UK National Survey 2006–2007. [http://www.ic.nhs.uk/webfiles/Services/NCASP/Heart/reports/National%20Report%202006%20version%202.1%20SUMMARY.pdf] (accessed June 25 2008).
3. McComb JM, Plummer CJ, Charles R, Cunningham M, Cunningham A. Inequity of access to cardiac pacing: results of a national survey (abstract). Heart (2007) 93(Suppl. 1):A46.
4. Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, et al. ACC/AHA/NASPE 2002 Guideline update for implantation of cardiac pacemakers and antiarrhythmia devices - summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to update the 1998 pacemaker guidelines). J Am Coll Cardiol (2002) 40:1703–19.
5. Mackintosh A, Boyle R. Reasons for delay in permanent pacemaker insertion. J R Coll Physicians (1986) 20:220–1.
6. Zeltzer D, Justo D, Halkin A, Rosso R, Ish-Shalom M, Hochenberg M, et al. Drug-induced atrioventricular block: prognosis after discontinuation of the culprit drug. J Am Coll Cardiol (2004) 44:105–8.
7. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NAM, Freedman RA, Gettes LS, et al. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline update for implantation of cardiac pacemakers and antiarrhythmia devices) Developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol (2008) 51:e1–62. [http://content.onlinejacc.org/cgi/content/full/j.jacc.2008.02.032] (accessed June 25 2008).
8. The Task Force for Cardiac Pacing and Cardiac Resynchronization Therapy of the European Society of Cardiology. Developed in collaboration with the European Heart Rhythm Association. Guidelines for cardiac pacing and cardiac resynchronization therapy. In: Europace (2007) 9:959–98. [http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-cardiac-pacing-ES.pdf] Last accessed 25th June 2008.
9. ACC/AHA pocket guideline: device-based therapy of cardiac rhythm abnormalities. (2008) [http://www.acc.org/ qualityandscience/clinical/guidelines/dbt/DBT_Pocket_Guide.pdf] (accessed June 25 2008).
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  M. S. Cunnington, C. J. Plummer, and J. M. McComb A survey of investigations performed prior to permanent pacemaker implantation Age Ageing, November 24, 2009; (2009) afp207v1. [Full Text] [PDF]
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