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Cochrane Database of Systematic Reviews

Hybrid repair versus conventional open repair for aortic arch dissection

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DOI:
https://doi.org/10.1002/14651858.CD012920Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 19 January 2018see what's new
Type:
  1. Intervention
Stage:
  1. Protocol
Cochrane Editorial Group:
  1. Cochrane Vascular Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Edel P Kavanagh

    Correspondence to: Department of Vascular and Endovascular Surgery, The Galway Clinic, Galway, Ireland

    [email protected]

  • Fionnuala Jordan

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

  • Niamh Hynes

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

  • Ala Elhelali

    Mechanical and Industrial Engineering, Galway‐Mayo Institute of Technology, 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

  • Sherif Sultan

    Vascular Surgery, Galway University Hospital, Galway, Ireland

Contributions of authors

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

Sources of support

Internal sources

  • No sources of support supplied

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
FJ: none known
NH: has received payment as a member of the Peripheral Advisory Board and for consultation on Regulatory Documents from Lake Region Medical, for medical device design at Boston Scientific (Enterprise Ireland Bioinnovate Fellow). Her institution has received payment for lectures and presentations from Gore Medical. She has no competing interests, relationships, conditions or circumstances which will conflict with this review.
AE: none known
DD: none known
DV: none known
SS: has received payment for training physicians on endovascular aortic repair from Gore Medical and is the Prinicpal Invesigator in the INSIGHT post Market Surveillance trial of the INCRAFT© abdominal aortic endograft (Cordis/Cardinal health). He has no conflict of interest which will effect this review.

Acknowledgements

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

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

Notes

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

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Table 1. Definition of outcome measures (Yan 2014)

Types of outcome measures

Defined by

Including

Primary outcomes

Mortality

Dissection related and all cause

(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.

Figures and Tables -
Table 1. Definition of outcome measures (Yan 2014)
Table 2. Summary of findings

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

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Open repair

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 basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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 quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Figures and Tables -
Table 2. Summary of findings