Hybrid repair versus conventional open repair for aortic arch dissection

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

doi:10.1002/14651858.CD012920.pub2

Reparación híbrida versus reparación abierta convencional para la disección del arco aórtico

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Referencias de los estudios excluidos de esta revisión

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NCT00526487. Clinical study to assess safety and effectiveness of the Zenith® dissection endovascular system in patients with aortic dissection. clinicaltrials.gov/ct2/show/NCT00526487 (first received 10 September 2007).

NCT00583817. Endovascular exclusion of ascending and thoracic aortic pathology. clinicaltrials.gov/ct2/show/NCT00583817 (first received 31 December 2007).

NCT01107366. ATLANTIS: extensive type A dissections and thoracic/ thoraco-abdominal aneurysms repair with LupiAe Hybrid TechNique (ATLANTIS). clinicaltrials.gov/ct2/show/NCT01107366 (first received 21 April 2010).

NCT01500395. Hybrid operation in thoracic aortic dissection. clinicaltrials.gov/ct2/show/NCT01500395 (first received 28 December 2011).

NCT01568320. Zenith® dissection clinical trial. clinicaltrials.gov/ct2/show/NCT01568320 (first received 2 April 2012).

NCT01704391. Haemodynamic response to aortic surgery. clinicaltrials.gov/ct2/show/NCT01704391 (first received 11 October 2012).

NCT02094300. Zenith® dissection endovascular system (STABLE I). clinicaltrials.gov/ct2/show/NCT02094300 (first received 14 September 2015).

NCT02201589. Feasibility of endovascular repair of ascending aortic pathologies. clinicaltrials.gov/ct2/show/NCT02201589 (first received 28 July 2014).

NCT02464943. Zenith® dissection endovascular system in the treatment of patients with aortic dissections. clinicaltrials.gov/ct2/show/NCT02464943 (first received 8 June 2015).

NCT02724072. Thoraflex™ Hybrid IDE Study. clinicaltrials.gov/ct2/show/NCT02724072 (first received 31 March 2016).

NCT03322033. Feasibility of endovascular repair of ascending aortic pathologies (PS-IDE). clinicaltrials.gov/ct2/show/NCT03322033 (first received 26 October 2017).

Tsukui H, Aomi S, Tomioka H, Nonoyama M, Koyanagi H, Nagasawa C, et al. Arch-first technique for aortic arch operation using branched graft. Asian Cardiovascular and Thoracic Annals 2002;10(4):318-21.

Referencias de los estudios en curso

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ChiCTR-IPR-16009372. Therapeutic strategy of aortic arch for acute type A aortic dissection. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IPR-16009372 (first received 11 October 2016).

ChiCTR-TRC-11001828. The contrast of the outcome between replacing ascending aorta + reconstructing aortic arch with triple-branched stent graft and replacing ascending aorta + replacing half aortic arch to treat the aortic dissection (the contrast of the outcome of the two different operational methods to treat the aortic dissection). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-TRC-11001828 (first received 27 July 2015).

ChiCTR-TRC-13003857. Evaluate the safety and efficacy of Xuper open surgery stent graft system for the surgical of type A aortic dissection: a prospective, multi-center clinical trial. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-TRC-13003857 (first received 31 May 2016).

Referencias adicionales

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Referencias de otras versiones publicadas de esta revisión

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otras referencias

Kavanagh EP, Jordan F, Hynes N, Elhelali A, Devane D, Veerasingam D, et al. Hybrid repair versus conventional open repair for aortic arch dissection. Cochrane Database of Systematic Reviews 2018, Issue 1. Art. No: CD012920. [DOI: 10.1002/14651858.CD012920]

Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

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estudios en curso

Study	Reason for exclusion
NCT00526487	Did not meet review indication (descending thoracic dissection)
NCT00583817	Did not meet review intervention (endovascular)
NCT01107366	Study withdrawn. The study was never started as was unable to obtain ethical approval.
NCT01500395	Did not meet review study design (registry)
NCT01568320	Did not meet review indication (patients with acute complicated type B aortic dissections)
NCT01704391	Did not meet review indication (abdominal aortic aneurysm)
NCT02094300	Did not meet review indication (Stanford type B, deBakey type III)
NCT02201589	Did not meet review intervention (endovascular)
NCT02464943	Did not meet review indication (patients with acute, complicated type B aortic dissection)
NCT02724072	Did not meet review study design (single arm study)
NCT03322033	Did not meet review intervention (TEVAR)
Tsukui 2002	Specific population cannot be extracted (mixture of lesion type and extent)

TEVAR: thoracic endovascular aortic repair

Characteristics of ongoing studies [ordered by study ID]

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estudios excluidos

ChiCTR‐IPR‐16009372

Study name	Therapeutic strategy of aortic arch for acute type A aortic dissection
Methods	Randomised parallel controlled
Participants	Participants diagnosed with type A aortic dissection by CTA imaging, onset time less than 2 weeks Age minimum: 18; age maximum: 70 Gender: both
Interventions	TAR group: total arch replacement ARP group: arch reserved procedure Hybrid group: hybrid procedure TBSG group: triple‐branched stent graft
Outcomes	Primary outcomes: postoperative 30‐day mortality; postoperative 30‐day major adverse cardiocerebral events (MACCE); postoperative 1‐year mortality; postoperative 1‐year major adverse cardiocerebral events (MACCE) Secondary outcomes: acute kidney injury; renal replacement therapy; hypoxaemia; liver failure; paraplegia; mediastinal infection; reopening for bleeding; ICU length of stay; postoperative hospital length of stay; hospitalisation expense; follow‐up CTA imaging
Starting date	11 January 2017
Contact information	Name: Song Xue Address: 160 Pujian Road, Shanghai 200127 Telephone: +86 13501754558 Email: [email protected] Affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, CHINA
Notes	The study investigators have been contacted for clarification, and possible results. No response has been received

ChiCTR‐TRC‐11001828

Study name	The contrast of the outcome between replacing ascending aorta + reconstructing aortic arch with triple‐branched stent graft and replacing ascending aorta + replacing half aortic arch to treat the aortic dissection (the contrast of the outcome of the two different operational methods to treat the aortic dissection)
Methods	Randomised parallel controlled trial
Participants	Participants diagnosed with aortic dissection; type A; onset time < 2 weeks
Interventions	Test group: place triple‐branched stent graft into aortic arch to reconstruct
Outcomes	Primary outcomes: operation time; length of stay; aortic angiography CT
Starting date	01 February 2009
Contact information	Name: Chen Liang‐Wan Address: 29 Xinquan Road, Fuzhou, Fujian 350001 Telephone: +86 13358255333 Email: [email protected] Affiliation: The Affiliated Union Hospital, Fujian Medical University, CHINA
Notes	The study investigators have been contacted for clarification, and possible results. No response has been received

ChiCTR‐TRC‐13003857

Study name	Evaluate the safety and efficacy of Xuper open surgery stent graft system for the surgical of type A aortic dissection: a prospective, multi‐center clinical trial
Methods	Randomised parallel controlled trial
Participants	Inclusion criteria Aged 18 to 65 years Participant or legal representative is able to understand and willing to provide written informed consent to participate in the trial Diagnosed with Stanford type A aortic dissection Anatomical morphology of aortic arch meets the basic requirement of implantation device Participant without surgical contraindications which include severe function insufficiency of liver, kidney, heart or lung, or a history of cerebral coma Exclusion criteria: Women in pregnancy or lactation; Patients with thrombocytopenia or are undergoing anticoagulant therapy Patients who are currently receiving dialysis treatment or the renal function are impaired (serum creatinine > 200 umol/L) The patient has had surgical repair of thoracoabdominal aortic aneurysm The branches of aortic arch vascular variation; aberrant right/left subclavian artery, innominate artery and left common carotid artery from a common stem; vertebral artery directly originated from the aortic arch, etc. The patient had suffered myocardial infarction within 3 months before screening Pulmonary dysfunction: forced expiratory volume at 1st second < 1.0/L, PaO₂ < 60 mmHg, PaCO₂ > 50 mmHg Patients with severe heart disease at present (such as congestive heart failure, untreated or deterioration of cardiac arrhythmias, ventricular arrhythmias) Patients with known allergy to contrast agent and the anaesthetic Patients with active systemic infection Patients have been involved in other drugs or medical‐device clinical trials Whether before or after the treatment, patient who the investigator judges may have medical, social or psychological problems that make them unsuitable to participate in this study Age minimum: 18 Age maximum: 65 Gender: Both
Interventions	Test group: Xuper Open Surgery Stent Graft System (Lifetech Scientific, Shenzhen, China) Control group: open surgical repair using the Intergard artificial graft (Getinge AB, Stockholm, Sweden)
Outcomes	Primary outcomes: duration of circulatory arrest Secondary outcomes: incidence of major adverse events (death, paraplegia, brain complications); stent implantation successful (stent in place and successfully released); operation time; cardiopulmonary bypass time; arterial anastomosis time; aortic occlusion time; intraoperative blood loss and blood transfusion volume; treatment success (12 months after operation)
Starting date	31 May 2013
Contact information	Name: Zhiyun Xu Address: 168 Changhai Road, Yangpu District, Shanghai 200433 Telephone: +21 81871114 Email: [email protected] Affiliation: Changhai Hospital of Second Military Medical University Name: Xiangman Zhang Address: Cybio Electronic Building, Langshan 2nd Street, North Area of High‐tech Park, Nanshan District, Shenzhen, Guangdong, CHINA 518057 Telephone: +86 13817024547 Email: [email protected] Affiliation: Lifetech Scientific (Shenzhen) Co.Ltd
Notes	The study investigators have been contacted for clarification, and possible results. No response has been received

ARP: arch reserved procedure; CT: Computed tomography; CTA: Computed tomography angiography; MACCE: major adverse cardiocerebral events; TAR: total arch replacement; TBSG: triple‐branched stent graft

Figure 1

Study flow diagram.

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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.

Table 1. Definition of outcome measures (Yan 2014)

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Table 2. Draft Summary of Findings table

Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
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	Risk with open repair	Risk with hybrid repair	Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
Mortality, Follow‐up: median N (months)	Study population		HR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Mortality, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	HR N (N to N)	N (N)
Neurological deficit, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Neurological deficit, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (N)
Cardiac injury, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Cardiac injury, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (N)
Respiratory compromise, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Respiratory compromise, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (N)
Renal ischaemia, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Renal ischaemia, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (N)
False lumen thrombosis, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
False lumen thrombosis, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (N)
Mesenteric ischaemia, Follow‐up: median N (months)	Study population		RR N (N to N)	N (N)	⊕⊝⊝⊝ very low ⊕⊕⊝⊝ low ⊕⊕⊕⊝ moderate ⊕⊕⊕⊕ high
Mesenteric ischaemia, Follow‐up: median N (months)	N per 1000	N per 1000 (N to N)	RR N (N to N)	N (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

Table 2. Draft Summary of Findings table

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Referencias

Referencias de los estudios excluidos de esta revisión

NCT00526487 {published data only}

NCT00583817 {published data only}

NCT01107366 {published data only}

NCT01500395 {published data only}

NCT01568320 {published data only}

NCT01704391 {published data only}

NCT02094300 {published data only}

NCT02201589 {published data only}

NCT02464943 {published data only}

NCT02724072 {published data only}

NCT03322033 {published data only}

Tsukui 2002 {published data only}

Referencias de los estudios en curso

ChiCTR‐IPR‐16009372 {published data only (unpublished sought but not used)}

ChiCTR‐TRC‐11001828 {published data only (unpublished sought but not used)}

ChiCTR‐TRC‐13003857 {published data only (unpublished sought but not used)}

Referencias adicionales

Antoniou 2010

Bellomo 2004

Cao 2012

Cochennec 2013

Czerny 2019

Daily 1970

Dake 2013

DeBakey 1966

Elhelali 2021

Estrera 2003

Fillinger 2010

GRADEproGDT 2015 [Computer program]

GRADE Working Group 2004

Groysman 2011

Guyatt 2008a

Guyatt 2008b

Hagan 2000

Higgins 2011

IMPROVE 2015

IRAD

Jakob 2011

Kamiya 2007

Kurimoto 2015

Lefebvre 2011

Liberati 2009

Lu 2013

Moon 2011

Moulakakis 2013

Murphy 2012

Murphy‐Ryan 2010

Mussa 2016

Nienaber 2004

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Nordon 2012

O'Callaghan 2014

Okita 2001

Pape 2007

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Patel 2011

Rampoldi 2007

Review Manager 2020 [Computer program]

Schünemann 2006

Shrestha 2014

Smith 2017

Sobocinski 2011

Sun 2011

Suzuki 2003

Tierney 2007

Tominaga 2003

Tran 2009

Trimarchi 2005

Trimarchi 2010

Vohra 2012

Wong 2008

Yan 2014

Yang 2019

Yu 2019

Referencias de otras versiones publicadas de esta revisión

Kavanagh 2018