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Cochrane Database of Systematic Reviews

Hybrid repair versus conventional open repair for aortic arch dissection

Información

DOI:
https://doi.org/10.1002/14651858.CD012920.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 25 julio 2021see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Vascular

Copyright:
  1. Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Edel P Kavanagh

    Department of Vascular and Endovascular Surgery, The Galway Clinic, Galway, Ireland

  • Sherif Sultan

    Vascular Surgery, Galway University Hospital, Galway, Ireland

  • Fionnuala Jordan

    School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland

  • Ala Elhelali

    School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland

  • Declan Devane

    School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland

  • Dave Veerasingam

    Cardiothoracic Surgery, Galway University Hospital, Galway, Ireland

  • Niamh Hynes

    Correspondencia a: Department of Vascular and Endovascular Surgery, The Galway Clinic, Galway, Ireland

    [email protected]

Contributions of authors

EPK: acquiring trial reports, trial selection, data extraction, data analysis, data interpretation, and review drafting,
SS: review drafting
FJ: data interpretation
AE: acquiring trial reports, trial selection, and data extraction
DD: data interpretation
DV: review drafting
NH: trial selection, data interpretation, review drafting, future review updates, and guarantor of the review

Sources of support

Internal sources

  • No sources of support provided

External sources

  • Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK

    The Cochrane Vascular editorial base is supported by the Chief Scientist Office.

Declarations of interest

EPK: none known.
SS: SS and his institution have received payment from Gore Medical for training physicians on endovascular aortic repair. SS is the Principal Investigator in the INSIGHT post Market Surveillance trial of the INCRAFT abdominal aortic endograft (Cordis/Cardinal health). He reports he has no conflict of interest which will affect this review.
FJ: Institution received funding from the Health Research Board (Ireland) for a Cochrane Training Fellowship to enable me to undertake a Cochrane Systematic Review over 24 months. This training grant provides me with funding to attend Cochrane Training Programmes/conferences over the two year period of my fellowship.
AE: has received funding from Health Research Board (Ireland) under the HRB Cochrane Ireland Fellowship Scheme to undertake a Cochrane Systematic Review (Elhelali 2021) (Grant number CTF‐2016‐1863).
DD: none known.
DV: none known.
NH: has received payment for consultation on Regulatory Documents (Versono Ltd and Integer) and for working on medical device design at Boston Scientific (Enterprise Ireland Bioinnovate Fellow). Her institution has received payment for provision of training on endovascular aortic repair from Gore Medical. She is investigator in the INSIGHT Post Market Surveillance Trial of the Incraft AAA device (Cordis/Cardinal Health). Her Institution has received payment for an Aortic Fellowship grant (Jotec/Cryolife), and Research fellowship grants (Gore Medical and Medtronic). She declares no competing interests, relationships, conditions or circumstances, which will conflict with this review.

Acknowledgements

We are very grateful to Cochrane Vascular for their support and guidance in the preparation of this review.

The review authors and the Cochrane Vascular editorial base are grateful to the following peer reviewers for their time and comments: Piergiorgio Cao FRCS, Senior Professor of Vascular Surgery, University of Perugia; Consultant Vascular Surgeon, Ospedale Bel Colle Viterbo, Clinica Mater Dei Roma, Rome, Italy; Mr Stephen Badger, Belfast Health & Social Care Trust, Belfast, UK.

Version history

Published

Title

Stage

Authors

Version

2021 Jul 25

Hybrid repair versus conventional open repair for aortic arch dissection

Review

Edel P Kavanagh, Sherif Sultan, Fionnuala Jordan, Ala Elhelali, Declan Devane, Dave Veerasingam, Niamh Hynes

https://doi.org/10.1002/14651858.CD012920.pub2

2018 Jan 19

Hybrid repair versus conventional open repair for aortic arch dissection

Protocol

Edel P Kavanagh, Fionnuala Jordan, Niamh Hynes, Ala Elhelali, Declan Devane, Dave Veerasingam, Sherif Sultan

https://doi.org/10.1002/14651858.CD012920

Differences between protocol and review

There are no differences between the protocol and review.

Notes

Parts of the Methods section of this review are based on a standard template established by Cochrane Vascular.

Keywords

MeSH

Medical Subject Headings Check Words

Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.

Figuras y tablas -
Figure 1

Study flow diagram.

Table 1. Definition of outcome measures (Yan 2014)

Types of outcome measures

Defined by

Including

Primary outcomes

Mortality

Dissection related and all causes

(Grade V)

All deaths at 30 days and 12 months

Neurological deficit

Global events

(Grade I ‐ IV)

Postoperative agitation, delirium, obtundation, or myoclonic movements, without localised cerebral neurological signs

Focal events

(Grade I ‐ IV)

Lateralising sensory or motor deficit or focal seizure activity

Spinal neurological events

(Grade I ‐ IV)

Paraplegia, paraparesis

Cardiac injury

Myocardial ischaemia

(Grade I ‐ IV)

Low cardiac output syndrome

(Grade I ‐ IV)

Arrhythmia

(Grade I ‐ IV)

Pericardial effusion

(Grade I ‐ IV)

Respiratory compromise

Parenchymal complications

(Grade I ‐ IV)

Atelectasis, pneumonia, pulmonary oedema, and acute respiratory distress syndrome

Pleural complications

(Grade I ‐ IV)

Pneumothorax, pleural effusion

Renal ischaemia

Modified RIFLE classification (Bellomo 2004):

Risk (I), Injury (II), Failure (III), Loss/End‐Stage Kidney Dysfunction (IV)

(Grade I ‐ IV)

Serum creatinine increase, glomerular filtration rate (GFR) decrease, anuria, haemodialysis

Secondary outcomes

False lumen thrombosis

Partial or complete thrombosis

Mesenteric ischaemia

Gut complications

(Grade I ‐ IV)

Ileus or gastric paresis, gut ischaemia manifested as metabolic acidosis or increased lactate

Grades as defined by Yan 2014:

Grade I: any deviation from the normal postoperative course but self‐limiting or requiring simple therapeutic regimens (including antiemetics, antipyretics, analgesics, electrolytes, and physiotherapy);

Grade II: complications requiring pharmacological treatment for resolution;

Grade III: complications requiring surgical, endoscopic, or radiological intervention but not requiring regional or general anaesthesia or requiring interdisciplinary intervention;

Grade IV: complications requiring surgical, endoscopic, or radiological intervention under regional or general anaesthesia, or requiring new intensive care unit (ICU) admission or ongoing ICU management for > 7 days or hospitalisation for > 30 days, or causing secondary organ failure;

Grade V: death caused by a complication.

Figuras y tablas -
Table 1. Definition of outcome measures (Yan 2014)
Table 2. Draft Summary of Findings table

Summary of findings for the main comparison: Hybrid repair versus conventional open repair for aortic arch dissection

Patient or population: patients with a diagnosis of aortic arch dissection

Settings: hospital

Intervention: hybrid repair

Comparison: open repair

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with open repair

Risk with hybrid repair

Mortality,

Follow‐up: median N (months)

Study population

HR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

Neurological deficit,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

Cardiac injury,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

Respiratory compromise,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

Renal ischaemia,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

False lumen thrombosis,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

Mesenteric ischaemia,

Follow‐up: median N (months)

Study population

RR

N

(N to N)

N
(N)

⊕⊝⊝⊝
very low

⊕⊕⊝⊝
low

⊕⊕⊕⊝
moderate

⊕⊕⊕⊕
high

N per 1000

N per 1000
(N to N)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; N: number; HR: hazard ratio; RR: risk ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Figuras y tablas -
Table 2. Draft Summary of Findings table