Giuseppe Boriani1,2, Matteo Bertini3, Davide Saporito4, Giuseppina Belotti5, Fabio Quartieri6, Corrado Tomasi7, Angelo Pucci8, Giulio Boggian9, Gian Franco Mazzocca10, Davide Giorgi11, Paolo Diotallevi12, Biagio Sassone9,13, Diego Grassini14, Alessio Gargaro14, Mauro Biffi2. 1. Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy. 2. Institute of Cardiology, S.Orsola University Hospital, University of Bologna, Bologna, Italy. 3. Arcispedale S. Anna-Cona, Università di Ferrara, Ferrara, Italy. 4. Ospedale degli Infermi, Rimini, Italy. 5. Ospedale Treviglio-Caravaggio, Treviglio, Italy. 6. Ospedale S. Maria Nuova, IRCCS, Reggio Emilia, Italy. 7. Ospedale S. Maria delle Croci, Ravenna, Italy. 8. Ospedale di Carrara, Carrara, Italy. 9. Ospedale di Bentivoglio, Bentivoglio, Italy. 10. Ospedale Civile, Cecina, Italy. 11. Ospedale San Luca, Lucca, Italy. 12. Clinica Città di Alessandria, Alessandria, Italy. 13. Ospedale SS Annunziata Cento (FE), Ferrara, Italy. 14. Biotronik Italia spa, Milan, Italy.
Abstract
BACKGROUND: The rate of device replacement in pacemaker recipients has not been investigated in detail. HYPOTHESIS: Current pacemakers with automatic management of atrial and ventricular pacing output provide sufficient longevity to minimize replacement rate. METHODS: We considered a cohort of 542 pacemaker patients (age 78 ± 9 years, 60% male, 71% de-novo implants) and combined 1-month projected device longevity with survival data and late complication rate in a 3-state Markov model tested in several Monte Carlo computer simulations. Predetermined subgroups were: age < or ≥ 70; gender; primary indication to cardiac pacing. RESULTS: At the 1-month follow-up the reported projected device longevity was 153 ± 45 months. With these values the proportion of patients expected to undergo a device replacement due to battery depletion was higher in patients aged <70 (49.9%, range 32.1%-61.9%) than in age ≥70 (24.5%, range 19.9%-28.8%); in women (39.9%, range 30.8%-48.1%) than in men (32.0%, range 24.7%-37.5%); in sinus node dysfunction (41.5%, range 30.2%-53.0%) than in atrio-ventricular block (33.5%, range 27.1-38.8%) or atrial fibrillation with bradycardia (27.9%, range 18.5%-37.0%). The expected replacement rate was inversely related to the assumed device longevity and depended on age class: a 50% increase in battery longevity implied a 5% reduction of replacement rates in patients aged ≥80. CONCLUSIONS: With current device technology 1/4 of pacemaker recipients aged ≥70 are expected to receive a second device in their life. Replacement rate depends on age, gender, and primary indication owing to differences in patients' survival expectancy. Additional improvements in device service time may modestly impact expected replacement rates especially in patients ≥80 years.
BACKGROUND: The rate of device replacement in pacemaker recipients has not been investigated in detail. HYPOTHESIS: Current pacemakers with automatic management of atrial and ventricular pacing output provide sufficient longevity to minimize replacement rate. METHODS: We considered a cohort of 542 pacemaker patients (age 78 ± 9 years, 60% male, 71% de-novo implants) and combined 1-month projected device longevity with survival data and late complication rate in a 3-state Markov model tested in several Monte Carlo computer simulations. Predetermined subgroups were: age < or ≥ 70; gender; primary indication to cardiac pacing. RESULTS: At the 1-month follow-up the reported projected device longevity was 153 ± 45 months. With these values the proportion of patients expected to undergo a device replacement due to battery depletion was higher in patients aged <70 (49.9%, range 32.1%-61.9%) than in age ≥70 (24.5%, range 19.9%-28.8%); in women (39.9%, range 30.8%-48.1%) than in men (32.0%, range 24.7%-37.5%); in sinus node dysfunction (41.5%, range 30.2%-53.0%) than in atrio-ventricular block (33.5%, range 27.1-38.8%) or atrial fibrillation with bradycardia (27.9%, range 18.5%-37.0%). The expected replacement rate was inversely related to the assumed device longevity and depended on age class: a 50% increase in battery longevity implied a 5% reduction of replacement rates in patients aged ≥80. CONCLUSIONS: With current device technology 1/4 of pacemaker recipients aged ≥70 are expected to receive a second device in their life. Replacement rate depends on age, gender, and primary indication owing to differences in patients' survival expectancy. Additional improvements in device service time may modestly impact expected replacement rates especially in patients ≥80 years.
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