Cardioverter-defibrillator implantation and generator replacement in the octogenarian

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1 Europace (2015) 17, doi: /europace/euu248 CLINICAL RESEARCH Sudden death and ICDs Cardioverter-defibrillator implantation and generator replacement in the octogenarian Manoj Goonewardene, Sérgio Barra*, Patrick Heck, David Begley, Simon Fynn, Munmohan Virdee, Andrew Grace, and Sharad Agarwal Cardiology Department, Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge CB23 3RE, UK Received 21 April 2014; accepted after revision 18 August 2014; online publish-ahead-of-print 23 October 2014 Aims Increase in life expectancy has led to increased rate of implantable cardioverter-defibrillator (ICD) implantation in patients in their 80s, but there are no current formal recommendations to guide physicians when elderly patients with ICDs require elective unit replacement (EUR). This study aims at assessing survival and rates of ICD therapies in patients who have had ICD implantation or EUR above the age of 80, focusing on the latter.... Methods Retrospective analysis of a prospectively kept database of all ICD-related procedures carried out in a single tertiary and results centre. Patients 80 years of age or older submitted to ICD implantation (n ¼ 42) or EUR (n ¼ 34) between November 1991 and May 2012 were included. Using collected baseline and outcome data from this cohort, we assessed survival of these patients and the rates of ICD therapies. Median additional years of life after ICD implantation and ICD EUR in patients who died before data retrieval was 2.5 and 1.2, respectively, and while 65% of deceased patients after ICD implantation died in the first 3 years after the procedure, 50% of deceased post-icd EUR patients died within the first year. Mortality rates at 1 and 2 years post-eur were 23.1 and 38.1%, respectively. Furthermore, ventricular tachycardia occurred in a small minority of patients after EUR (16.7%) and no ventricular fibrillation-triggered ICD therapies were reported in both groups.... Conclusion In octogenarians who are due for an ICD EUR, careful thought should be given to the current clinical status, comorbidities, and general frailty prior to considering them for the procedure. A survival benefit from ICD EUR in this age stratum is not likely Keywords Implantable cardioverter-defibrillator Generator replacement Elderly people Mortality Ventricular arrhythmias Introduction Over the last 20 years, we have seen a substantial and progressive increase in the number of implantable cardioverter-defibrillator (ICD) implantations around the globe. The increase in life expectancy in the last decades and an ageing population in the developed world has led to an increased rate of ICD implantation in patients in their 70s and 80s and subsequently an increase in the number of elderly patients requiring elective ICD generator replacement. With limited resources, society is forced to make decisions about which services to offer which patients and base those decisions on objective evidence of benefit. 1 However, although the management of life-threatening ventricular arrhythmias in the elderly is becoming increasingly important as the population continues to age, this sub-group of patients, particularly octogenarians, constitute an understudied segment of those potentially eligible for ICD implantation. A natural question to arise is whether older patients get the same benefit from this device as their younger counterparts. As most major clinical trials evaluating ICD therapy have either excluded this segment of the population or enrolled a verysmall number of octogenarians, the true effectiveness of the ICD when used in routine clinical practice in elderly patients is uncertain. Most importantly, there are no current formal recommendations to guide physicians when elderly patients with ICDs require elective unit replacement (EUR). The primary aim of our study was to assess survival of octogenarian patients who have had ICD implantation or ICD EUR, with a clear focus on the latter sub-group. Moreover, the rates of ICD therapies in these patients will also be addressed. * Corresponding author. Tel: address: sergioncbarra@gmail.com Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com.

2 410 M. Goonewardene et al. What s new? This is the first study evaluating the survival of octogenarian patients following implantable cardioverter-defibrillator (ICD) elective unit replacement (EUR). We found a low survival time in octogenarian patients admitted for ICD implantation or EUR, especially the latter. While 65% of deceased patients after ICD implantation died in the first 3 years after the procedure, 50% of deceased post-icd EUR patients died within the first year. Sustained ventricular tachycardia (VT) occurred in a small minority of patients after EUR and no true ventricular fibrillation events were reported in both groups. Importantly, VT episodes or ICD therapies were not detected in patients who had not had such events before the EUR. Our data suggesting high mortality rates in octogenarian ICD recipients may support the need and feasibility of a randomized controlled trial. Replacing the ICD generator in very elderly patients without previous ICD therapies is hardly of clinical benefit. Methods Study design Retrospective analysis of a prospectively kept database of all ICD-related procedures carried out in a single tertiary centre. All patients 80 years of age or older who were submitted to ICD implantation or EUR between November 1991 and May 2012 were included. Using collected baseline data at the time of the procedure and outcome data from this cohort, we assessed survival of these patients and the rates of ICD therapies. Patients and eligibility criteria Between November 1991 and May 2012, a total of 1166 patients were submitted to ICD implantation, with or without resynchronization therapy, at the Electrophysiology Department of a tertiary referral hospital centre. Of these, 42 individuals were 80 years old at the time of ICD implantation (Figure 1). In the same time period, 329 elective ICD or cardiac resynchronization therapy-defibrillator (CRT-D) generator replacements were performed in 297 patients, of whom 34 were 80 years old at the time of their last ICD EUR (Figure 1). Data collection The following data were systematically collected: group characterization with information on medical history, medication, demographic, clinical, and echocardiographic data, and device characteristics; follow-up data including ICD therapies [shocks or antitachycardia pacing (ATP)] and allcause mortality. Study endpoints and patient follow-up The primary outcome of this study was all-cause mortality during followup. The secondary outcome was the occurrence of ICD therapies during follow-up. Follow-up data were obtained through review of clinical records from outpatient and ICD clinics and hospital ward admissions and through phone calls for the six patients who were not followed at our institution (all submitted to ICD implantation). Number of patients Number of patients Results ICD implants per age group Age groups ICD EUR per age group Age groups Figure 1 Rates of ICD implants and ICD generator replacements per age group in our hospital between 1991 and Septuagenarians represented almost one-third of all patients having ICD implantation, which adds to the relevance of this article, as octogenarians will represent a very prevalent group of individuals potentially entitled to ICD generator replacement in the near future. Implantable cardioverter-defibrillator implantation Of the 1166 ICD implants that took place, 42 (3.6%) were performed in patients 80 years old and 352 (30.2%) in septuagenarians. The ICD was implanted for primary prevention of sudden cardiac death (SCD) in 10 cases. Since their ICD implantation, 17 (40%) of the 42 octogenarian patients had died and 25 (60%) were still alive. Table 1 describes the cohort of elderly patients admitted for ICD implantation according to their survival status at the time of data retrieval (May 2012). Surviving patients had their ICDs implanted at mean age of 82.1 (range ) and their average follow-up was 3.1 years (range ). Forty-four per cent were still within the first 3 years of their ICD implant. Regarding those who died during follow-up, themean age at thetime of implantation was82.2 years(range ), whilemeanage at the time of death was 85.4 years (range ). The median additional years of life after ICD implantation was 2.5 (range ). These data contrast with median additional years of life of 3.51 in patients younger than 80 who had died at the time of data retrieval. Thirty per cent of deceased octogenarians died within the first 2 years after the procedure and a further 35% were reported deceased in the third year, a total of 65% in the first 3 years after ICD implant (vs. 44% in those younger than 80).

3 ICD generator replacement in the octogenarian 411 Table 1 Patients 80 years of age or older admitted for ICD implantation Surviving Deceased patients patients (N 5 25) (N 5 17)... Age at implant Age at last follow-up/age at death Additional years of life Male gender 88% 82.4% Reason for implant: primary/ 24%/76% 23.5%/76.5% secondary prevention of SCD History of coronary artery 88% 88.2% disease a History of atrial fibrillation 16% 17.6% Previous VT ablation 8% 0% Severe LV systolic function b 88% 68.8% Dual-chamber ICD 48% 58.8% CRT 24% 17.6% Beta-blockers at implant 80% 58.8% Antiarrhythmics at implant c 68% 64.7% ACEI and/or ARB 96% 88.2% VT post-icd implantation 40% 35.3% VF post-implantation 0% 0% Any appropriate ICD therapy 28% (n ¼ 7) 29.4% (n ¼ 5) Any ICD shock 8% (n ¼ 2) 17.6% (n ¼ 3) ATP only 20% (n ¼ 5) 5.9% (n ¼ 1) Both 8% (n ¼ 2) 11.8% (n ¼ 2) Any inappropriate ICD therapy 8% 0% ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin-ii receptor blocker; ATP, antitachycardia pacing; ICD, implantable cardioverter-defibrillator; LV, left ventricular; SCD, sudden cardiac death; VT, ventricular tachycardia. a Defined as the presence of at least one significant coronary lesion (.50% obstruction) in at least one major coronary artery. b Defined as left ventricular ejection fraction,30%. c Amiodarone in all cases. There was a non-significant difference in survival (time to death or duration of follow-up) among people who had received ICD for primary prevention (median of 1.69 years) vs. secondary prevention (median 2.89 years). During follow-up, 12 of the 42 patients had at least one episode of ventricular tachycardia (VT) treated by the ICD, but ventricular fibrillation (VF)-triggered ICD shocks were not reported. All of these patients, except one, had their ICDs implanted as secondary prevention. The remaining 30 patients did not have any therapy delivered by their ICDs. The median follow-up and/or additional years of life after ICD implantation in patients who had ICD therapies (shock or ATP) after the procedure was 2.0 (vs. 2.3 in those without ICD therapies). Implantable cardioverter-defibrillator elective generator replacement A total of 297 patients had elective ICD or CRT-D generator replacements (a total of 329 procedures). While 92 patients (31%) were Cumulative survival Months Figure 2 Cumulative survival of octogenarian patients submitted to ICD generator replacement. septuagenarians, 34 individuals (11.4%) were 80 years old or older at the time of their last EUR. Their median age was and a median of 8.26 years had passed since the ICD implantation. Since their procedure, 12 (35.3%) of the octogenarian patients had died and 22 (64.7%) were still alive when data were retrieved. Mortality rates at 1 and 2 years of follow-up were 23.1 and 38.1%, respectively. Figure 2 illustrates cumulative survival during follow-up. Forty-seven (18%) of the 263 patients whose last ICD EUR was performed before the age of 80 had died at the time data were collected. Tables 2 and 3 describe the cohort of elderly patients admitted for ICD or CRT-D EUR according to their survival status at the time of data retrieval (May 2012). Surviving patients had their EUR at mean age of 81.2 (range ) and their average follow-up was 2.1 years (range , median 1.28). Regarding those who died during follow-up, mean age at the time of implantation was 82.0 (range ), while mean age at the time of death was 83.8 (range ). On average, these patients lived an additional 1.84 years (range ) after the procedure. Median additional years of life after the last ICD EUR was 1.24, less than half the median additional years of life in individuals younger than 80 (2.69 years). Six (50%) of the 12 patients died within the first year, practically twice the mortality rate of patients younger than 80 in the first year after the procedure (25.5%). Of those who died, five (41.7%) had had the ICD initially implanted for primary prevention of SCD (vs. three patients among those who were still alive at the time of data collection, 13.6%). There was a nonsignificant difference in median survival post-icd EUR among people who had received ICD for primary prevention (0.69 years) vs. secondary prevention (1.55 years).

4 412 M. Goonewardene et al. Table 2 Patients 80 years of age or older admitted for ICD or CRT-D EUR Surviving Deceased patients patients (N 5 22) (N 5 12)... Age at last EUR Age at last follow-up/age at death Additional years of life Male gender 78.3% 83.3% Reason for implant: primary/ 12.5%/87.5% 41.7%/58.3% secondary prevention of SCD History of coronary artery 86.3% 83.3% disease a Severe LV systolic function b 59.1% 66.7% Haemoglobin (g/dl) c Creatinine (mmol/l) c Dual-chamber ICD 54.5% 50% CRT 27.2% 0% Beta-blockers at EUR 63.6% 66.7% Antiarrhythmics at EUR d 63.6% 75% ACEI and/or ARB at EUR 91% 91.7% VT post-initial ICD implantation and before last EUR 54.5% 50% VT post-last EUR 27.3% 16.7% VF post-last EUR 0% 0% Any appropriate ICD therapy 13.6% 8.3% Any ICD shock 0% 0% ATP only 13.6% 0% Both 0% 8.3% Any inappropriate ICD therapy 0% 0% ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin-ii receptor blocker; ATP, antitachycardia pacing; EUR, elective unit replacement; ICD, implantable cardioverter-defibrillator; LV, left ventricular; SCD, sudden cardiac death; VT, ventricular tachycardia. a Defined as the presence of at least one significant coronary lesion (.50% obstruction) in at least one major coronary artery. b Defined as left ventricular ejection fraction,30%. c Collected within a 6-month period before the procedure (including the pre-procedural hospital admission). d Amiodarone in all cases. Although 18 of 34 patients had had at least one episode of VT detected by their ICDs before the last EUR, these were only detected in six patients after this last procedure, of whom five had ICD therapies (ATP in all cases, except one patient who had ATP-induced acceleration of his VT into the VF zone, triggering an ICD shock). There were no true episodes of VF detected after the EUR. Five of the six individuals who presented VT during follow-up were still alive at the time of data collection. In all six cases, except one, the ICD had been initially implanted for secondary prevention. The median follow-up and/or additional years of life after ICD EUR in patients who had ICD therapies (shock or ATP) after the procedure was 1.1 (vs. 1.3 in those without ICD therapies). Discussion Main findings of our study We found a low survival time in octogenarian patients admitted for ICD implantation or EUR, especially the latter. In fact, the median additional years of life after ICD implantation and ICD EUR in patients who died before data retrieval was 2.5 and 1.2, respectively, and while 65% of deceased patients after ICD implantation died in the first 3 years after the procedure, 50% of deceased post-icd EUR patients died within the first year. In both groups (ICD implantation and ICD EUR), the risk of mortality seemed higher in patients who had the device implanted for primary prevention of SCD (vs. secondary prevention) and most episodes of VT treated by the ICD were seen in those who had the ICD implanted for secondary prevention. Furthermore, VT occurred in a small minority of patients after EUR and no true VF events were reported in both groups. Importantly, VT episodes or ICD therapies were not detected in patients who had not had such events before the EUR. Figure 3 summarizes these findings. The high percentage of septuagenarians among patients submitted to ICD implantation in our institution (30.2%) assumes particular importance in the sense that, in the next decade, octogenarians may represent a very important and prevalent sub-group of individuals potentially entitled to ICD generator replacement. Although the current international recommendations consider ICD implantation as Rarely Appropriate in nonagenarian patients only, the appropriateness of ICD insertion and, in particular, generator replacement in octogenarians should be properly addressed in future guidelines. Implantable cardioverter-defibrillator implantation in the elderly: what is the evidence? The mechanism of death changes with advancing age in patients with ischaemic cardiomyopathy or congestive heart failure, with a diminishing proportion of sudden death with advancing age. Krahn et al. 2 have shown that only 26% of deaths are classified as sudden after the age of 80. Most major clinical trials evaluating ICD therapy have either excluded elderly and very elderly patients or enrolled a very small number of octogenarians. In the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) trials, average age of enrolled patients was 64 and 60, respectively, 3,4 and some studies have purposely excluded patients above the age of 80. 5,6 Observational studies of ICD therapy in the elderly suggesting a reduction in mortality are difficult to interpret due to selection bias towards healthier people being offered ICDs in this age group. One meta-analysis has tried to address these questions by looking at the use of ICDs for primary prevention in five key randomized controlled trials [MADIT, MUSTT, MADIT-II, Defibrillators in Non-ischemic Cardiomyopathy Treatment Evaluation (DEFINITE), and SCD-HeFT]. It suggested a higher reduction in all-cause mortality among patients years of age when compared with individuals 75 years of age or older (40 vs. 27%, respectively). 7 One of the largest single-centre registries addressing this subject showed a median survival of 4.2 years in 107 octogenarians compared with 7 years in a control group aged A meta-analysis by Healey et al. 9

5 ICD generator replacement in the octogenarian 413 Table 3 Patients 80 years of age or older admitted for ICD elective generator replacement between November 1991 and May 2012 Indication for ICD Age at Age of death/at Additional Appropriate ICD Appropriate ICD ICD-treated VF implantation EUR last follow-up a years of life b therapies before therapies after EUR after EUR d EUR c... Patient 1 SP Yes No No Patient 2 PP Yes No No Patient 3 PP Yes Yes No Patient 4 SP Yes No No Patient 5 PP No No No Patient 6 SP No No No Patient 7 SP No No No Patient 8 PP No No No Patient 9 PP No No No Patient 10 SP Yes No No Patient 11 SP No No No Patient 12 SP Yes No No Patient 13 SP Yes Yes No Patient 14 SP No No No Patient 15 SP Yes Yes No Patient 16 SP No No No Patient 17 SP No No No Patient 18 SP Yes No No Patient 19 SP No No No Patient 20 PP No No No Patient 21 SP Yes No No Patient 22 SP No No No Patient 23 PP Yes No No Patient 24 SP Yes No No Patient 25 PP Yes No No Patient 26 SP Yes No No Patient 27 SP No No No Patient 28 SP Yes No No Patient 29 SP Yes No No Patient 30 SP Yes Yes No Patient 31 SP Yes Yes No Patient 32 SP No No No Patient 33 SP Yes No No Patient 34 SP No No No The first 12 patients (highlighted in red) had died before data were retrieved in May EUR, elective unit replacement; ICD, implantable cardioverter-defibrillator; PP, primary prevention; SP, secondary prevention; VF, ventricular fibrillation. a Last follow-up data were collected at the end of May b Difference between age at the time of death or at last follow-up and age at the time of the procedure. c Defined as ATP therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either VF or VT. d Defined as shock therapy for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be true VF. Additional notes: Patient 3 ICD programmed to VT zone.169 b.p.m. and VF zone.240 b.p.m. Occurrence of one VT episode falling into VT zone, accelerated to a faster VT by first ATP and to a faster rhythm falling into the VF zone by a second ATP and finally treated with ICD shock. Patient did not lose consciousness and was unaware of whole episode, including shock. Patient 13 One episode of VT at 183 b.p.m. lasting for 53 s and causing syncope. Therapy was withheld due to gradual onset, so subsequently discriminators were turned off and VT zoneloweredto160 b.p.m. Furtherepisodesofasymptomaticnon-sustainedVTdetected, predominantly lasting,10 s. Onelongerbutasymptomaticepisodetreatedwithoneburst of ATP. Patient 15 Two episodes of asymptomatic VT (longest one was 17 beats long at 390 ms) successfully terminated with ATP. Patient 30 One asymptomatic episode falling into the VF zone (.207 b.p.m.), terminated successfully by ATP (ICD was programmed to deliver ATP while charging). Patient 31 Three episodes of VT (cycle length 330, 340, and 280 ms, respectively) successfully treated with one burst of ATP. Patient complained of palpitations.

6 414 M. Goonewardene et al. November 1991 to May 2012 ICD implantation ICD elective unit replacement Total 1131 patients 1166 procedures 297 patients 329 procedures 80 years of age or older 42 patients 34 patients Surviving patients - 25 patients - VT in 10 - VF in 0 Deceased patients Surviving patients - 22 patients - VT in 6 - VF in 0 Deceased patients - 17 patients - VT in 6 - VF in 0-12 patients - VT in 2 - VF in 0 Figure 3 Summary of our study results. pooled individual patient data from all three secondary prevention trials comparing ICD to amiodarone [Antiarrhythmics versus Implantable Defibrillators (AVID), Canadian Implantable Defibrillator Study (CIDS), and Cardiac Arrest Study Hamburg (CASH)] and concluded that ICD therapy does not seem to offer a survival benefit in secondary prevention patients 75 years of age or older. The AVID trial, in particular, showed an unadjusted average of only 2.7 months of additional life gained at 3 years in a cohort of patients with mean age of Whereas elderly patients exhibit increased non-sudden mortality after ICD implantation, rates of appropriate device shocks do not seem to decline significantly with older age after primary and secondary prevention ICD implantation, 11 suggesting a potential dissociation between arrhythmic risk and all-cause mortality in this age stratum. Implantable cardioverter-defibrillator generator replacement in the elderly: are we providing our patients with the necessary information for an autonomous decision? Although some studies have tried to evaluate the potential benefit of ICD implantation in elderly patients, there are no formal recommendations to guide physicians when elderly patients with ICDs require EUR. This is the first study evaluating the survival of octogenarian patients after an ICD EUR. An analysis of the patients from the National Cardiovascular Data Registry (NCDR w ) ICD Registry TM receiving ICD generator replacements at the end of device battery life concluded that older age is an independent predictor of mortality following this procedure. 12 Disabling or downgrading an ICD can be a difficult decision and involves multiple ethical, moral, clinical, and legal issues. Elderly patients are more likely to experience other non-cardiac-related medical problems making end-of-life decisions even more important. Discussing end-of-life issues with patients prior to implanting the device, complying with the request of competent patients to turn off device therapies, allowing no distinction between a patient refusing to undergo device implantation and one requesting device disablement and transferring care to another physician who is willing to comply with such request when one is uncomfortable with disabling a device on a moral ground are some of the proposed measures for terminally ill patients with an ICD. 13 Some studies have suggested that heart failure patients express meaningful preferences about quality vs. length of life, with younger patients preferring increased survival whereas older patients often consider quality of life of greater importance. 14 Also, patients that have more than one shock, inappropriate or appropriate, experience a reduced quality of life. 15 In our study, we noticed a high postprocedural all-cause mortality rate in elderly patients undergoing elective replacement of their ICD generator despite the absence of VF-triggered ICD therapies and the low incidence of sustained VT. Importantly, only two of the patients who had died before data retrieval had ICD therapies during follow-up, suggesting a much stronger role for non-arrhythmic death. These data may question the applicability of ICD generator replacement in very elderly patients with no history of complex ventricular arrhythmias.

7 ICD generator replacement in the octogenarian 415 In octogenarians who are due for an ICD EUR, several arguments can be made for either downgrading the ICD to a standard pacemaker (if pacing support is needed) or simply not replacing it at all. On one hand, patients who demonstrate recovery of left ventricular function from cardiac resynchronization or medical therapy may be at lower risk of arrhythmic mortality when compared with the preprocedural estimated risk, as demonstrated by Schliamser et al. 16 The absence of complex ventricular arrhythmias or appropriate ICD therapies since initial implantation may identify a sub-group of patients at lower risk of arrhythmic death. Furthermore, some patients may develop comorbidities that may put them at increased risk of non-cardiac death. With increasing age, some patients may feel differently towards their final mode of death and may wish to have their device deactivated. One option would be to have the shocking capability turned off while leaving ATP turned on, if this has been previously shown to be effective. A recent study analysed intracardiac electrograms in 125 explanted ICDs from deceased individuals and, although the majority of patients were in a hospital or care facility at the time of death and the most common cause of death was congestive heart failure, the authors concluded that more than one-third of the patients had ventricular tachyarrhythmia events with shocks within the last hour of life. Furthermore, 65% of the patients with a do-not-resuscitate order still had shock therapy programmed on at 24 h before death, which allowed for the delivery of shock treatment in almost one-fourth of these patients. 17 Conversely, one could also argument towards replacing the device. These patients are still at considerable risk of SCD, especially when they have had previous appropriate ICD therapies, and, as some individuals get used to a psychological sense of security from their device, they may find it traumatizing to manage without it. Moreover, new treatments developed for heart failure and other noncardiac medical conditions might reduce their risk of non-sudden death. Limitations The small size of the study sample and the retrospective nature of the study are its most important limitations. The former is a result of the restricted use of devices in England during part of the study period and precludes any meaningful analysis on potential predictors of mortality in this sub-group of patients. Ultimately, these limitations reinforce the need for national or international registries of ICD EURs in elderly patients. Nevertheless, the relevance of this study is highlighted by the total absence of data in the literature on ICD generator replacements in elderly patients. Furthermore, about three-fourths of implants (including the original implant in patients having EUR after the age of 80) were for secondary prevention, which does not reflect medical practice in other regions of the world and is also a result of the restricted use of devices in England during part of the study period. A multicentre study including a higher number of patients would allow a more complete analysis on the impact of ICD implantations and ICD generator replacements according to the indication for the procedure (primary vs. secondary prevention). We cannot estimate the potential survival benefit (if any) and future arrhythmic mortality risk based on the rate of shocks or ATP events delivered for VT, as this is strongly dependent on how the ICD has been programmed. Various studies have shown the importance of appropriate ICD programming in reducing the incidence of ICD therapy (ATP and shocks) and eventually the risk of mortality. 20 We did not present information on ICD programming due to the fact that procedures were performed throughout a relatively long period of time (more than a decade). However, it is noteworthy that ICD shocks for VF did not occur after any of the ICD implants and EUR. Another important consideration relates to the fact that age-adjusted mortality probably dropped over this period of more than 20 years due to better care for patients with coronary heart disease and heart failure. However, this hardly explains our findings, as only 3 of the octogenarian patients submitted to ICD EUR had the procedure performed before 2006, and 19 had the procedure by 2010 or latter. Conclusion In octogenarians who are due for an ICD implant and especially ICD generator replacement, careful thought should be given to their current clinical status, comorbidity burden, mental functioning, and general frailty. Decisions should be made between clinicians and the patient taking into account their personal preferences and, particularly in the case of ICD EUR, fully explaining that a survival benefit from the procedure is not expected, especially in those without previous ICD therapies. Establishing an international registry of all ICD implants and generator replacements in octogenarians is likely to prove helpful. Our data suggesting high mortality rates in this cohort of patients may support the need and feasibility of a randomized controlled trial, which may assess directly whether or not elderly and very elderly patients actually benefit from ICD implantation or generator replacement. Conflicts of interest: none declared. References 1. Markowitz SM. 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