Reduction in inappropriate therapies through device programming in subcutaneous implantable defibrillator patients: data from clinical practice

Author:

Rordorf Roberto1ORCID,Viani Stefano2ORCID,Biffi Mauro3ORCID,Pieragnoli Paolo4ORCID,Migliore Federico5ORCID,D’Onofrio Antonio6ORCID,Nigro Gerardo7ORCID,Francia Pietro8ORCID,Ferrari Paola9,Dello Russo Antonio10ORCID,Bisignani Antonio1112ORCID,Ottaviano Luca13ORCID,Palmisano Pietro14ORCID,Caravati Fabrizio15ORCID,Pisanò Ennio16ORCID,Pani Antonio17ORCID,Botto Giovanni Luca18ORCID,Lovecchio Mariolina19,Valsecchi Sergio19ORCID,Vicentini Alessandro1ORCID

Affiliation:

1. Cardiac Intensive Care Unit, Arrhythmia and Electrophysiology and Experimental Cardiology, IRCCS Fondazione Policlinico S. Matteo , Viale Camillo Golgi, 19, 27100 Pavia , Italy

2. Cardiology Unit, Azienda Ospedaliera Universitaria Pisana , via Paradisa, 2, 56123 Pisa , Italy

3. Department of Experimental, Diagnostic and Specialty Medicine, Institute of Cardiology, University of Bologna, Policlinico S.Orsola-Malpighi , Via Giuseppe Massarenti, 9 40138 Bologna , Italy

4. Department of Cardiology, University of Florence , Largo Giovanni Alessandro Brambilla, 3, 50134 Firenze , Italy

5. Department of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova , Via Nicolò Giustiniani, 2, 35128 Padova , Italy

6. ‘Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie’, Monaldi Hospital , Via Leonardo Bianchi, 80131 Napoli , Italy

7. Department of Translational Medical Sciences, University of Campania ‘Luigi Vanvitelli’ , Piazza Luigi Miraglia, 2, 80138 Napoli , Italy

8. Cardiology, Department of Clinical and Molecular Medicine, Sant’Andrea Hospital, University Sapienza , Via di Grottarossa, 1035/1039, 00189 Roma , Italy

9. Cardiac Electrophysiology and Pacing Unit, Papa Giovanni XXIII Hospital , Piazza OMS, 1, 24127 Bergamo , Italy

10. Department of Biomedical Sciences and Public Health, Cardiology and Arrhythmology Clinic, Università Politecnica delle Marche , Via Conca, 71, 60126 Ancona , Italy

11. Division of Cardiology, Castrovillari Hospital , Via Padre Pio da Pietralcina, 87012, Castrovillari (CS) , Italy

12. Institute of Cardiology, Catholic University of the Sacred Heart , Largo Agostino gemelli, 8, 00168 Roma , Italy

13. Arrhythmia and Electrophysiology unit, Cardiothoracic Department Clinical Institute S. Ambrogio , Via Privata Val Vigezzo, 5, 20149 Milano , Italy

14. Cardiology Unit, ‘Card. G. Panico’ Hospital , Via San Pio X, 4, 73039 Tricase (LE) , Italy

15. Ospedale di Circolo e Fondazione Macchi , Via Luigi Borri, 57, 21200 Varese , Italy

16. Department of Cardiology, ‘Vito Fazzi’ Hospital , Piazza Filippo Muratore, 1, 73100 Lecce , Italy

17. Cardiology Division, ‘A. Manzoni’ Hospital , Via Eremo, 9/11, 23900 Lecco , Italy

18. Department of Clinical cardiology and Electrophysiology ASST Rhodense, Rho and Garbagnate M.se , Corso Europa, 250, 200117 Rho (MI) , Italy

19. Rhythm Management Division, Boston Scientific , Viale Enrico Forlanini, 23, 20134 Milano , Italy

Abstract

Abstract Aims In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. Methods and results We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200–220) and the shock zone cut-off was 230 bpm (IQR: 210–250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230–250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25–0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. Conclusions In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD   Clinical Trial Registration URL: http://clinicaltrials.gov/Identifier: NCT02275637

Publisher

Oxford University Press (OUP)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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