Device programing and SMART pass algorithm activation in subcutaneous implantable defibrillator patients: Data from a remote monitoring database

Author:

Iacopino Saverio1,Santobuono Ezio2,Amellone Claudia3,Rapacciuolo Antonio4,Lavalle Carlo5ORCID,La Greca Carmelo6,Santini Luca7ORCID,Bertini Matteo8ORCID,Statuto Giovanni1ORCID,Lovecchio Mariolina9,Valsecchi Sergio9,Tavoletta Vincenzo10

Affiliation:

1. Arrhythmology Department Maria Cecilia Hospital Ravenna Italy

2. Cardiology Unit Polyclinic of Bari Department of Emergency and Organ Transplantation University of Bari Aldo Moro Bari Italy

3. Department of Cardiology Martini‐Maria Vittoria Hospital, ASL Città di Torino Turin Italy

4. Department of Advanced Biomedical Sciences Federico II University of Naples Naples Italy

5. Policlinico Umberto I University La Sapienza Rome Italy

6. Department of Cardiology Fondazione Poliambulanza Brescia Italy

7. Department of Cardiology “G.B. Grassi” Hospital Rome Italy

8. Cardiology Unit University of Ferrara S. Anna University Hospital Ferrara Italy

9. Rhythm Management Division Boston Scientific Milan Italy

10. Unità Operativa di Elettrofisiologia Studio e Terapia delle Aritmie, Monaldi Hospital Naples Italy

Abstract

AbstractBackgroundThe programing of subcutaneous implantable cardioverter‐defibrillators (S‐ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks.PurposeWe assessed device programing during follow‐up and the rate of detected arrhythmias in consecutive S‐ICD recipients.MethodsWe analyzed data from 670 S‐ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th–75th percentile: 16–51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate.ResultsAt the latest remote data transmission, the median conditional zone cut‐off was set to 210 bpm (25th–75th percentile: 200–220), the shock zone cutoff was 250 bpm (25th–75th percentile: 240–250), and the SMART Pass was enabled in 586 (87%) patients. During follow‐up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled ‐0.12/patient‐year (95% CI: 0.10–0.14) versus 0.20 (95% CI: 0.15–0.26) (p = .002), as it was the rate of untreated arrhythmias ‐0.12/patient‐year (95% CI: 0.11–0.14) versus 0.23 (95% CI: 0.18–0.30) (p = .001). The enhanced SMART Pass version was associated with a lower rate of deactivations ‐0.04/patient‐year (95% CI: 0.02–0.05) versus 0.14 (95% CI: 0.12–0.16) (p < .001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28–0.53) and 0.40 (95% CI: 0.30–0.55), respectively (p < .001)).ConclusionsCenters tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias.

Publisher

Wiley

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