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.

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.