Pacemaker replacement in nonagenarians: Procedural safety and long-term follow-up




Summary


Background


The rate of pacemaker implantation is rising. Given that the life expectancy of the population is projected to increase, a large number of elderly patients are likely to be implanted in the future. As pacemaker batteries can last for 8–10 years, an increasing number of pacemaker recipients will require replacement of their devices when they become nonagenarians.


Aims


To analyse the short- and long-term outcomes after device replacement in nonagenarians.


Methods


Patients aged ≥ 90 years referred to a tertiary centre for pacemaker replacement from January 2004 to July 2014 were included retrospectively. Clinical follow-up data were obtained from clinical visits or telephone interviews with patients or their families. The primary clinical endpoint was total mortality. Secondary endpoints included early and delayed procedure-related complications and predictive risk factors for total mortality.


Results


Sixty-two patients were included (mean age 93.3 ± 2.9 years at time of pacemaker replacement). Mean procedure duration was 35.7 ± 17.2 minutes. Mean hospital stay was 2.2 ± 1.1 days. One patient died from a perioperative complication. Thirty-seven patients (59.7%) died during a median follow-up of 22.1 months (interquartile range, 11.8–39.8 months). Survival rates were 84.2% (95% confidence interval [CI] 71.8–91.5%) at 1 year, 66.9% (95% CI 51.8–78.2%) at 2 years and 22.7% (95% CI 10.6–37.7%) at 5 years. Atrial fibrillation (hazard ratio 2.47, 95% CI 1.1–5.6) and non-physiological pacing (i.e. VVI pacing in patients in sinus rhythm) (hazard ratio 2.20, 95% CI 1.0–4.9) were predictors of mortality.


Conclusions


Pacemaker replacement in nonagenarians is a safe and straightforward procedure. These data suggest that procedures can be performed securely in this old and frail population, with patients living for a median of 30 months afterwards.


Résumé


Contexte


Le taux d’implantation de stimulateurs cardiaques est en croissance constante. L’espérance de vie augmentant, de nombreuses personnes âgées seront implantées dans le futur. L’autonomie des batteries des stimulateurs étant de 8 à 10 ans, de nombreux patients nécessiteront le remplacement de leur appareil à > 90 ans.


Buts


Étudier le devenir à court et à long terme des nonagénaires après remplacement de leur stimulateur cardiaque.


Méthodes


Tous les patients nonagénaires adressés pour un changement de stimulateur cardiaque entre janvier 2004 et juillet 2014 ont été inclus de façon rétrospective. Les données cliniques étaient obtenues lors des consultations de suivi ou par téléphone auprès des patients ou de leurs familles. Le critère primaire de jugement était la mortalité toutes causes. Les critères secondaires comprenaient les complications immédiates et à long terme, ainsi que les facteurs prédictifs de mortalité toutes causes.


Résultats


Soixante-deux patients ont été inclus (93,3 ± 2,9 ans, durée de procédure 35,7 ± 17,2 minutes). Un patient est décédé d’une complication périopératoire. Durant le suivi, 37 patients (59,7 %) sont décédés. Le taux de survie était respectivement de 84,2 % (IC 95 % 71,8–91,5 %), 66,9 % (IC 95 % 51,8–78,2 %) et 22,7 % (IC 95 % 10,6–37,7 %) après 1, 2 et 5 ans. La fibrillation atriale (HR 2,47, IC 95 % 1,1–5,6) et la stimulation cardiaque non physiologique (mode VVI chez les patients en rythme sinusal) (HR 2,20, IC 95 % 1,0–4,9) étaient des facteurs prédictifs indépendants de mortalité.


Conclusions


Le remplacement de stimulateurs cardiaques est une procédure simple pouvant être réalisée sans risques majeurs chez les nonagénaires. Après la procédure, la survie médiane est de 30 mois.


Background


In Europe, 933 pacemakers per million inhabitants are implanted every year . The implantation rate is rising continuously, partly because of the ageing of general population, resulting in an increased risk of developing atrioventricular (AV) block and sinus node dysfunction, but also related to the expansion of indications for cardiac resynchronization therapy (CRT). The average age at device implantation is currently 80 years .


In 2012, life expectancy in Europe was 80.3 years for the general population (83.1 years for women; 77.5 years for men), a 2.6-year increase since 2002 . By 2060, life expectancy is projected to be 89.1 years for women and 84.6 years for men . A 163.4% increase in the number of patients aged ≥ 80 years is expected. To date, only a few studies have specifically reported the long-term outcome of very elderly patients implanted with a cardiac pacemaker. In a recent study, Udo et al. evaluated the outcome of pacemaker recipients aged > 80 years, and reported a cumulative 5-year survival of around 50% after implantation, with a complication rate of 18.1% .


As pacemaker batteries can last for as long as 8–10 years, an increasing number of pacemaker recipients will probably require replacement of their devices when they are nonagenarians. No studies specifically reporting the outcome and survival of nonagenarians referred for pacemaker replacement have been published. Therefore, we aimed to analyse the short- and long-term outcomes after device replacement in these very elderly patients. Procedural characteristics, survival rate and causes of deaths were analysed in the present study.




Methods


Study population


The present study is based on a retrospective analysis of all consecutive patients aged > 90 years referred to our tertiary centre for device replacement from January 2004 to July 2014.


Clinical information was obtained from the patients’ medical records, which included patient demographics, medical history, medication use and history of pacing (indication of pacing, age at primary implantation, device type and number of replacements). “Physiological pacing” was defined as the implantation of a dual-chamber pacemaker or CRT-pacemaker (CRT-P) in patients in sinus rhythm and a single-chamber pacemaker in patients in atrial fibrillation (AF), while “non-physiological pacing” was defined as the implantation of a VVI chamber device in patients in sinus rhythm. The Charlson Co-morbidity Index, a validated score to assess patients’ co-morbidities, was evaluated using dedicated scales available online . Various Charlson indexes have been proposed, depending on the number of variables included. We decided, as previously performed by Mandawat et al. in their study of octogenarian and nonagenarian pacemaker recipients, to use the index that does not include age, as all our patients were ≥ 90 years .


The procedural characteristics of the device replacement were recorded, including the type of pacemaker implanted, duration of hospital stay and procedural complications.


Follow-up and outcomes


Clinical follow-up data were obtained from clinical visits or telephone interviews with patients or their families, general practitioners or nurses. The primary clinical endpoint was total mortality over the follow-up period (censor date 1 August 2014).


Causes of death were obtained through hospital discharge notes and inquiries made with the family, the general practitioner or nursing homes, and were classified using the International Statistical Classification of Diseases and Related Health Problems classification (ICD-10), as cardiovascular cause (I00-I99), pulmonary cause (J00-J99), neoplastic cause (C00-D48), renal cause (N00-N99), caused by multiple organ dysfunction (R65-10) or of unknown origin (R99). Deaths were classified as unknown when no specific cause could be identified. Patients lost to follow-up were censored as alive on the day of the last visit.


Secondary endpoints included early and delayed procedure-related complications and predictive risk factors for death.


Statistical analyses


Data are summarized as frequencies and percentages for categorical variables. Quantitative variables are expressed as means ± standard deviations. Qualitative data were compared using Fisher’s exact test, while quantitative data were compared using the Mann–Whitney test. Survival curves were estimated using Kaplan–Meier method, with log-rank tests for comparisons. The prognostic relevance of different characteristics to long-term survival was assessed in univariate and multivariable fashion using Cox’s proportional hazards regression analysis. In addition to age and sex, all values with P ≤ 0.2 in the univariate analysis were used for the multivariable analysis. All tests were two-sided at the 0.05 significance level. All statistical analyses were carried out using SPSS for Windows, version 16.0 (SPSS Inc., Chicago, IL, USA).




Results


Study population


From January 2004 to July 2014, 62 nonagenarian patients were referred for pacemaker replacement. Patient characteristics are described in Table 1 . The mean age was 93.3 ± 2.9 years at the time of replacement (range, 90–104 years) and 50% were men. Most patients were living at home (36 patients, 58.1%).



Table 1

Patient characteristics ( n = 62).







































































































































Data at the time of first implantation
Men 31 (50.0)
Age at first implantation (years) 81.9 ± 7.7 (53–95)
Indication for first implantation
High degree AV block 39 (63.0)
Sinus node dysfunction 14 (22.6)
High rate AF with AV junction ablation 3 (4.8)
Carotid sinus hypersensitivity 3 (4.8)
CRT-P for heart failure 2 (3.2)
Hypertrophic cardiomyopathy 1 (1.6)
Type of device before replacement
Single-chamber 15 (24.2)
Dual-chamber 45 (72.6)
CRT-P 2 (3.2)
Data at the time of device replacement
Age (years) 93.3 ± 2.9 (90–104)
BMI (kg/m 2 ) 24.1 ± 4.0
Time from first implantation to replacement (years) 11.4 ± 6.8
Heart rhythm at the time of replacement
Sinus rhythm 45 (72.5)
Persistent/permanent AF 17 (27.5)
Type of device after replacement
Single-chamber 27 (43.5)
Dual-chamber 32 (51.6)
CRT-P 3 (4.9)
Co-morbidities
Cardiac surgery 4 (6.5)
Coronary artery disease 11 (17.7)
Diabetes mellitus 4 (6.5)
Heart failure 28 (45.2)
History of AF 32 (51.6)
History of stroke 5 (8.1)
Hypertension 33 (53.2)
Valvular disease 18 (29.0)
Charlson Co-morbidity Index 1.5 ± 1.1
Treatments
Anticoagulants 12 (19.3)
Antiplatelets 32 (51.6)
Number of medications 5.4 ± 3.2
Blood work
Haemoglobin concentration (g/dL) 13.1 ± 1.4
Creatinine concentration (μmol/L) 109.1 ± 35.4
Patients living in nursing homes 26 (41.9)
Physiological stimulation 49 (79.0)

Only gold members can continue reading. Log In or Register to continue

Stay updated, free articles. Join our Telegram channel

Jul 11, 2017 | Posted by in CARDIOLOGY | Comments Off on Pacemaker replacement in nonagenarians: Procedural safety and long-term follow-up

Full access? Get Clinical Tree

Get Clinical Tree app for offline access