Antonino Nicosia1, Saverio Iacopino2, Gerardo Nigro3, Giulio Zucchelli4, Luca Tomasi5, Carlo D'Agostino6, Matteo Ziacchi7, Marcello Piacenti8, Paolo De Filippo9, Giuseppe Sgarito10, Giuseppe Campisi11, Daniele Nicolis12, Rosario Foti13, Pietro Palmisano14. 1. Azienda Sanitaria Provinciale di Ragusa, Ospedale Giovanni Paolo II, C.da Cisternazzi, Ragusa, Italy. antonino.nicosia@asp.rg.it. 2. GVM Care & Research, Cotignola, Italy. 3. Azienda Ospedaliera Dei Colli - Ospedale Monaldi, Naples, Italy. 4. Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 5. Azienda Ospedaliera Universitaria, Ospedale Borgo Trento, Verona, Italy. 6. Azienda Ospedaliera, Policlinico, Bari, Italy. 7. Azienda Ospedaliera Sant'Orsola Malpighi, Bologna, Italy. 8. Fondazione Gabriele Monasterio, Pisa, Italy. 9. Ospedale Giovanni Paolo XXIII, Bergamo, Italy. 10. Ospedale Civico, Palermo, Italy. 11. Azienda Sanitaria Provinciale di Ragusa, Ospedale Giovanni Paolo II, C.da Cisternazzi, Ragusa, Italy. 12. Ospedale Carlo Poma, Mantua, Italy. 13. Ospedale San Vincenzo, Taormina, Italy. 14. Ospedale Cardiale G Panico, Tricase, Italy.
Abstract
PURPOSE: Real-world safety data on the use of transcatheter pacing systems particularly in very elderly patients is still limited. The aim of this analysis was to investigate the effect of age on the safety and efficacy of leadless pacemaker implant. METHODS: From May 2016 through July 2019, 577 patients were implanted with a leadless single-chamber pacemaker according to current pacing indication in 15 Italian cardiologic centers. The population was divided into age quartiles for evaluation, including (1) < 70 years, (2) 70-77 years, (3) 78-83 years, and (4) ≥ 83 years. Procedural data, complications, and electrical parameters were collected at baseline and during the follow-up. RESULTS: Procedural-related complication occurrence was very low (< 1.0%) and similar in the four subgroups according to age even if the older patients were more frail. No cardiac tamponade was reported. Among the groups, no difference was observed in procedural time, fluoroscopy time duration, and electrical parameters (mean pacing impedance: 750 ± 192 and 599 ± 156, mean pacing threshold: 0.7 ± 0.5 and 0.7 ± 0.6, and mean right ventricular sensing 10.7 ± 6.1 and 11.5 ± 4.8 at implant and last follow-up, respectively). CONCLUSIONS: The reported data demonstrated a high degree of safety during leadless implant across all patient ages. Procedural complications and device electrical measurements were similar among the different ages.
PURPOSE: Real-world safety data on the use of transcatheter pacing systems particularly in very elderly patients is still limited. The aim of this analysis was to investigate the effect of age on the safety and efficacy of leadless pacemaker implant. METHODS: From May 2016 through July 2019, 577 patients were implanted with a leadless single-chamber pacemaker according to current pacing indication in 15 Italian cardiologic centers. The population was divided into age quartiles for evaluation, including (1) < 70 years, (2) 70-77 years, (3) 78-83 years, and (4) ≥ 83 years. Procedural data, complications, and electrical parameters were collected at baseline and during the follow-up. RESULTS: Procedural-related complication occurrence was very low (< 1.0%) and similar in the four subgroups according to age even if the older patients were more frail. No cardiac tamponade was reported. Among the groups, no difference was observed in procedural time, fluoroscopy time duration, and electrical parameters (mean pacing impedance: 750 ± 192 and 599 ± 156, mean pacing threshold: 0.7 ± 0.5 and 0.7 ± 0.6, and mean right ventricular sensing 10.7 ± 6.1 and 11.5 ± 4.8 at implant and last follow-up, respectively). CONCLUSIONS: The reported data demonstrated a high degree of safety during leadless implant across all patient ages. Procedural complications and device electrical measurements were similar among the different ages.
Authors: Mikhael El-Chami; Robert C Kowal; Kyoko Soejima; Philippe Ritter; Gabor Z Duray; Petr Neuzil; Lluis Mont; Alexander Kypta; Venkata Sagi; John Harrison Hudnall; Kurt Stromberg; Dwight Reynolds Journal: Pacing Clin Electrophysiol Date: 2017-06-16 Impact factor: 1.976
Authors: Fred M Kusumoto; Mark H Schoenfeld; Coletta Barrett; James R Edgerton; Kenneth A Ellenbogen; Michael R Gold; Nora F Goldschlager; Robert M Hamilton; José A Joglar; Robert J Kim; Richard Lee; Joseph E Marine; Christopher J McLeod; Keith R Oken; Kristen K Patton; Cara N Pellegrini; Kimberly A Selzman; Annemarie Thompson; Paul D Varosy Journal: Circulation Date: 2018-11-06 Impact factor: 29.690
Authors: Paul R Roberts; Nicolas Clementy; Faisal Al Samadi; Christophe Garweg; Jose Luis Martinez-Sande; Saverio Iacopino; Jens Brock Johansen; Xavier Vinolas Prat; Robert C Kowal; Didier Klug; Lluis Mont; Jan Steffel; Shelby Li; Dirk Van Osch; Mikhael F El-Chami Journal: Heart Rhythm Date: 2017-05-11 Impact factor: 6.343
Authors: Mikhael F El-Chami; Nicolas Clementy; Christophe Garweg; Razali Omar; Gabor Z Duray; Charles C Gornick; Francisco Leyva; Venkata Sagi; Jonathan P Piccini; Kyoko Soejima; Kurt Stromberg; Paul R Roberts Journal: JACC Clin Electrophysiol Date: 2019-01-30
Authors: Neal K Bhatia; Soroosh Kiani; Faisal M Merchant; David B Delurgio; Anshul M Patel; Angel R Leon; Michael S Lloyd; Stacy B Westerman; Anand D Shah; Mikhael F El-Chami Journal: J Cardiovasc Electrophysiol Date: 2020-12-07
Authors: Mikhael F El-Chami; Faisal Al-Samadi; Nicolas Clementy; Christophe Garweg; Jose Luis Martinez-Sande; Jonathan P Piccini; Saverio Iacopino; Michael Lloyd; Xavier Viñolas Prat; Michael Dilou Jacobsen; Philippe Ritter; Jens Brock Johansen; Claudio Tondo; Fang Liu; Dedra H Fagan; Alyssa K Eakley; Paul R Roberts Journal: Heart Rhythm Date: 2018-08-10 Impact factor: 6.343
Authors: Mikhael F El-Chami; Jens Brock Johansen; Amir Zaidi; Svein Faerestrand; Dwight Reynolds; Javier Garcia-Seara; Jacques Mansourati; Jean-Luc Pasquie; Hugh Thomas McElderry; Paul R Roberts; Kyoko Soejima; Kurt Stromberg; Jonathan P Piccini Journal: J Cardiovasc Electrophysiol Date: 2019-01-28