Wearable cardioverter-defibrillator (WCD) therapy as prevention of sudden cardiac death in patients at risk – Update 2022

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Research area: High tech medicine

Project leaders: Gregor Goetz

Project team: Gregor Goetz

and Bernhard Wernly
Duration: May 2022 – August 2022
Language: English with German Summary

Publication: Decision Support Document No. 103/2. Update 2022: https://eprints.aihta.at/1407/

Background: The wearable cardioverter defibrillator (WCD) is intended to provide protection against sudden cardiac death in high-risk patients: WCD-therapy is anticipated to be beneficial to cover the conservative therapy phase before the definitive indication of an ICD, to bridge a waiting period until ICD implantation that is necessary for patient-specific reasons, or to bridge a temporary high-risk phase [1]. The German evidence based guideline (AWMF-S3) states in 2021 that WCD-therapy can be used for a limited time in selected patients (Grade of recommendation: 0), although lack of evidence derived from high-quality randomised controlled trials (RCT) was highlighted [2].

For nearly two decades after the approval of the WCD, mainly observational WCD studies for the prevention of sudden cardiac death were published that provided conflicting data, yielding to the inability to draw firm conclusions on the clinical effectiveness and safety of the WCD [3-5]. In 2018, the first RCT was available (VEST/ Prevention of Early Sudden Death Trial), showing no reduction in sudden cardiac death when compared to medical therapy alone [6]. This trial was the basis of a joint collaborative health technology assessment between AGENAS (Itallian National Agency for Regional Health Services) and LBI-HTA (Ludwig Boltzmann Institute for Health Technology Assessment) that concluded that comparative effectiveness of the device is still not established [7]. The joint systematic review further found low-quality evidence (1 RCT and 10 observational studies) indicating that the WCD could be a relatively safe intervention for patients at risk of SCD. Another comprehensive meta-analysis came to a similar interpretation of the evidence [5]. However, intensive marketing hampered the scientific debate regarding the usefulness of the WCD [8, 9].

Due to the fact that the VEST results were limited by poor compliance, it is still unclear whether anticipated patient-relevant benefits of using the WCD (e.g., in certain clinical settings and/ or subgroups) is supported by scientific evidence.

Aims of the project: The project aims at performing an update evidence synthesis based on a systematic literature search regarding the effectiveness and safety of the WCD for specific indications.

Research Question:

  1. What is the evidence that the use of a WCD as a temporary measure (add-on or replacement) for the treatment of patients at risk of sudden cardiac death is more effective and safe than standard care without WCD, or as effective and safe as hospital observation with regard to the defined outcomes (see PICO)?
  2. Which (health-related) impacts (if any) does the WCD have on Quality of Life of patients?
  3. What is the satisfaction and compliance rate of patients with the WCD?

Methods: A systematic literature search will be conducted in four medical databases. To strengthen the systematic search, a hand-search in reference lists of recent articles will be conducted and manufacturers will be contacted. The EUnetHTA Core Model®  for Relative Effectiveness Assessment [10]will be used as reporting standard. All working steps of the systematic review (study selection, critical appraisal, data extraction) will be performed by two authors. The evidence will be qualitatively synthesised using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) method [11]. The Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) will be used in case subgroup analyses are available [12].

PICO-question:

Description

Project scope

Population

Population: adults over 18 years of age (according to CE mark) with the following indications:

  1. As a temporary intervention prior to the insertion of an ICD for:
    1. patients immediately after explantation of an ICD, if an immediate reimplantation of an ICD is not possible;
    2. patients in whom an immediate implantation of an ICD is indicated, but not possible due to temporary contraindications.
  2. As a temporary measure prior to optimal pharmacological therapy, or as a protection during pharmacological therapy optimisation when a heightened risk of SCD is present, but possibly resolvable over time or with treatment of left ventricular dysfunction; for patients with:
    1. ischaemic heart disease with envisaged or recent revascularization (90-day waiting period post revascularization with either CABG or PCI);
    2. secondary cardiomyopathy (tachycardia mediated, thyroid mediated, etc.) or induced arrhythmias (secondary to hypothermia, electrolyte imbalance, iatrogenic prolongation of the QT interval, etc.) in which the underlying cause is potentially treatable;
    3. with certain forms of structural heart disease associated with risk of malignant arrhythmias or primary electric diseases, prior to diagnostic tests such as MRI.
  3. Post Myocardial Infarction (MI) and LVEF of  <_ 35%, as a temporary measure during prognostic stratification in situations associated with increased risk of arrhythmic death within 40 d of MI
  4. As a temporary measure prior to heart transplantion in patients without ICD

Intervention

WCD (as add-on or replacement):
LifeVest® (WCD 4000) from ZOLL (Lifecor) Medical Corporation, Pittsburgh, PA, USA [13]

ASSURETM Wearable Cardioverter Defibrillator (WCD) from Kestra Medical Technologies, Inc.[14]

Comparator

Hospital observation, ; Guideline-Directed Medical Therapy (GDMT)

Outcomes

Effectiveness:

Primary endpoint:

  • Mortality:
    • All-cause mortality,
    • Disease-specific mortality.

Secondary endpoints:

  • HRQoL,
  • Hospitalisation rate,
  • Satisfaction,
  • Compliance.

Safety:

  • AEs, device related and patient related (frequency of AEs, what are these, frequency of discontinuation due to AEs, frequency of unexpected AEs),
  • SAEs, device related and patient related (frequency of SAEs, frequency of SAEs leading to death).

Study designs

Effectiveness: Randomised controlled trials (RCTs),  non-randomised controlled trials

Safety: Randomised controlled trials (RCTs),  non-randomised controlled trials, prospective case series studies and prospective register data with at least 100 patients

Publication period

08/2018-05/2022


Schedule/ milestones (in months):

Time frame

Task

April 2022

Scoping, precision of PICO-question

May 2022

Systematic literature search, manual web-based search, literature selection

June, July 2022

Data extraction, synthesis, and assessment of evidence, drafting of 1st version of HTA-report

August 2022

Internal review, formatting, preparation of final version of HTA-report, publication


References:

[1]          Schwab JO, Bänsch D, Israel C and Nowak B. Stellungnahme zum Einsatz des tragbaren Kardioverter/Defibrillators. Der Kardiologe. 2015; 9(2):165–170. DOI: 10.1007/s12181-015-0651-y.

[2]          Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF). Nationale VersorgungsLeitlinie (NVL). Chronische Herzinsuffizienz. 2021 [cited 15.04.2022]. Available from: https://www.leitlinien.de/themen/herzinsuffizienz.

[3]          S. Ettinger, M. Stanak, P. Szyma?ski, C. Wild, R. Tandara Ha?ek, D. Er?evi?, et al. Wearable cardioverter defibrillators for the prevention of sudden cardiac arrest: a health technology assessment and patient focus group study. Med Devices (Auckl). 2017;10:257-271. Epub 2017/11/29. DOI: 10.2147/mder.S144048.

[4]          M. Maceira Rozas, J. Puñal Riobóo and L. Varela Lema. 2018 - The LifeVest® wearable defibrillator in the prevention of risk for sudden cardiac arrest. 2018 [cited 15.04.2022]. Available from: https://avalia-t.sergas.es/Paxinas/web.aspx?tipo=paxtxt&idLista=4&idContido=771&migtab=39%3b771.

[5]          A. Masri, A. M. Altibi, S. Erqou, M. A. Zmaili, A. Saleh, R. Al-Adham, et al. Wearable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death: A Systematic Review and Meta-Analysis. JACC Clin Electrophysiol. 2019;5(2):152-161. Epub 2019/02/21. DOI: 10.1016/j.jacep.2018.11.011.

[6]          J. E. Olgin, M. J. Pletcher, E. Vittinghoff, J. Wranicz, R. Malik, D. P. Morin, et al. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018;379(13):1205-1215. Epub 2018/10/04. DOI: 10.1056/NEJMoa1800781.

[7]          E. Chiarolla, M. Orso, G. Götz, M. Stanak, C. Wild and T. Jefferson. Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk. Update 2018. Decision Support Document 103/ Update 2018. [cited 15.04.2022]. Available from: https://eprints.aihta.at/1186/.

[8]          J. Mandrola. The VEST Trial Failed, and So Did the Press Release. 2018 [cited 15.04.2022]. Available from: https://www.medscape.com/viewarticle/893756.

[9]          E. C. Stecker and M. N. Walsh. Wearable Cardioverter–Defibrillator after Myocardial Infarction. N Engl J Med. 2019;380(6):599. Epub 2019/02/08. DOI: 10.1056/NEJMc1816889.

[10]        EUnetHTA Joint Action 2. Work Package 8. HTA Core Model ® version 3.0. 2016 [cited 28.03.2022]. Available from: https://www.eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf?x37933.

[11]        G. Guyatt, A. D. Oxman, E. A. Akl, R. Kunz, G. Vist, J. Brozek, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64(4):383-394. Epub 2011/01/05. DOI: 10.1016/j.jclinepi.2010.04.026.

[12]        S. Schandelmaier, M. Briel, R. Varadhan, C. H. Schmid, N. Devasenapathy, R. A. Hayward, et al. Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses. Cmaj. 2020;192(32):E901-e906. Epub 2020/08/12. DOI: 10.1503/cmaj.200077.

[13]        Food and Drug Administration (FDA). LifeVest® Wearable Cardioverter Defibrillator. [cited 20.04.2022]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf/P010030S056B.pdf.

[14]        Food and Drug Administration (FDA). ASSURE Wearable Cardioverter Defibrillator System Kit. 2021. Available from: https://www.fda.gov/medical-devices/recently-approved-devices/assure-wearable-cardioverter-defibrillator-system-kit-pn-80014-001-monitor-pn-80008-003-therapy.