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Real-world experience with the wearable cardioverter defibrillator: clinical effectiveness and wear-time adherence in patients at high risk for sudden cardiac death

Alltagserfahrungen mit dem tragbaren Kardioverter/Defibrillator – klinische Effektivität und Einhaltung der Tragezeit bei Patienten mit hohem Risiko eines plötzlichen Herztods

Abstract

Background

Previous studies established a role for the wearable cardioverter defibrillator (WCD) to effectively and safely bridge temporary risk for sudden cardiac death (SCD) in patients with advanced heart failure. The prognostic relevance of the WCD remains controversial.

Objectives

The authors investigated adherence to, as well as the safety and effectiveness of, WCD use in a real-world cohort of patients at high risk for SCD.

Material and methods

All consecutive patients (n = 83) receiving a WCD at a German tertiary care hospital between April 2012 and December 2019 were retrospectively included in this analysis. Patient characteristics were collected at the time of the index hospitalization. Using the Zoll® lifeVest® (ZOLL Medical Corporation, Chelmsford, MA, USA) network database, two separate investigators evaluated adherence to the WCD as well as arrhythmic events during WCD wear time.

Results

During 3680 wearing days (mean WCD wear time, 44 days) with a median daily wear time of 23.1 h, three arrhythmic events of relevance (sustained ventricular tachycardia, VT) occurred, one of which was sufficiently terminated by WCD shock. Another patient died from sudden cardiac death while pausing his WCD. Right bundle branch block correlated significantly with sustained VT occurrence (r = 0.3315; 95% CI −0.1265 to 0.3014; p = 0.0022). In 30 patients (36.1%) a cardioverter/defibrillator was implanted.

Conclusion

In a real-life clinical setting, the use of WCD in patients at high risk for sudden cardiac death is effective and safe and adherence to the device is high. The event rate for VA was lower than in comparable patient cohorts. Adherence remains a crucial issue as one patient in the present series died while not wearing the device.

Zusammenfassung

Hintergrund

Frühere Studien belegen die Bedeutung des tragbaren Kardioverter/Defibrillators (WCD) für die wirksame und sichere Überbrückung eines temporären Risikos des plötzlichen Herztods (SCD) bei Patienten mit fortgeschrittener Herzinsuffizienz. Der prognostische Stellenwert einer solchen Therapie ist jedoch weiterhin umstritten.

Ziel der Arbeit

Wir untersuchten Adhärenz, Sicherheit und Effektivität der Kardioverter/Defibrillator-Weste im kardiologischen Versorgungsalltag einer Kohorte von Patienten mit hohem SCD-Risiko.

Material und Methoden

Alle 83 zwischen April 2012 und Dezember 2019 in einer deutschen Klinik der Tertiärversorgung mit einem WCD versorgten Patienten wurden retrospektiv in diese Analyse eingeschlossen. Die Basischarakteristika wurden im Rahmen der Indexhospitalisierung erhoben. Die Auswertung von WCD-Adhärenz und arrhythmogenen Ereignissen während der WCD-Tragezeit erfolgte durch zwei unabhängige Untersucher anhand der Daten des LifeVest® Network der Fa. Zoll® (ZOLL Medical Corporation, Chelmsford, MA, USA).

Ergebnisse

Während 3680 Tragetagen (mittlere WCD-Tragedauer 44 Tage) mit einer medianen täglichen Tragedauer von 23,1 h traten drei anhaltende ventrikuläre Tachykardien (VT) über 30 s Dauer auf. Davon konnte eine erfolgreich durch einen WCD-Schock terminiert werden. Ein anderer Patient erlag einem SCD, als er die Weste gerade nicht trug. Ein Rechtsschenkelblock korrelierte signifikant mit dem Auftreten einer anhaltenden VT (r = 0,3315; 95 %-Konfidenzintervall −0,1265 bis 0,3014; p = 0,0022). Bei 30 Patienten (36,1 %) wurde ein Kardioverter/Defibrillator implantiert.

Schlussfolgerung

Die Anwendung des WCD in einem Hochrisikokollektiv für SCD unter klinischen Alltagsbedingungen ist sicher und effektiv, die Adhärenz der Patienten ist hoch. Die Rate an Arrhythmieereignissen war geringer als in vergleichbaren Patientenkollektiven. Die Adhärenz bleibt ein entscheidendes Problem, da ein Patient bei fehlender individueller Compliance einem SCD erlag.

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Abbreviations

ARNI:

Angiotensin receptor neprilysin inhibitor

BMI:

Body mass index

CABG:

Coronary artery bypass graft

CAD:

Coronary artery disease

DCM:

Dilated cardiomyopathy

ICD:

Implantable cardioverter defibrillator

ICM:

Ischemic cardiomyopathy

LBBB:

Left bundle branch block

LVEF:

Left ventricular ejection fraction

MRA:

Mineralocorticoid receptor antagonist

RBBB:

Right bundle branch block

SCD:

Sudden cardiac death

VA:

Ventricular arrhythmias

VF:

Ventricular fibrillation

VT:

Ventricular tachycardia

WCD:

Wearable cardioverter defibrillator

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Funding

The author(s) received no financial support for the research, authorship and/or publication of this article.

Author information

Affiliations

Authors

Contributions

Christian Weth: Conceptualization, Methodology, Data curation, Investigation, Formal analysis, Roles/Writing of the original draft, Visualization, Project administration Hasan Abuazab: Data curation, Investigation Sebastian Ewen: Formal analysis, Validation, Resources Michael Böhm: Methodology, Supervision Christian Ukena: Supervision Florian Custodis: Conceptualization, Methodology, Resources, Validation, Writing of the review and editing, Project administration.

Corresponding author

Correspondence to Christian Weth.

Ethics declarations

Conflict of interest

C. Weth, H. Abuazab, C. Ukena and F. Custodis declare that they have no competing interests. S. Ewen received speaker or consultant honorarium from Medtronic, Recor, Bayer, Daiichi Sankyo, Boehringer Ingelheim, Novartis, AstraZeneca, Akcea Therapeutics and Bristol Myers Squibb Pfizer Alliance. M. Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939) and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Medtronic, Novartis, Servier and Vifor.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

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Weth, C., Abuazab, H., Ewen, S. et al. Real-world experience with the wearable cardioverter defibrillator: clinical effectiveness and wear-time adherence in patients at high risk for sudden cardiac death. Herzschr Elektrophys (2021). https://doi.org/10.1007/s00399-021-00816-w

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Keywords

  • Wearable electronic devices
  • Life Vest
  • Cardiomyopathy
  • Ventricular tachycardia
  • Heart failure

Schlüsselwörter

  • Wearables
  • LifeVest
  • Kardiomyopathie
  • Ventrikuläre Tachykardie
  • Herzinsuffizienz