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. 2021 Jul 25;7(7):CD012920.
doi: 10.1002/14651858.CD012920.pub2.

Hybrid repair versus conventional open repair for aortic arch dissection

Edel P Kavanagh  1 , Sherif Sultan  2 , Fionnuala Jordan  3 , Ala Elhelali  3 , Declan Devane  3 , Dave Veerasingam  4 , Niamh Hynes  1
Affiliations

Hybrid repair versus conventional open repair for aortic arch dissection

Edel P Kavanagh et al. Cochrane Database Syst Rev. .

Abstract

Background: A dissection of the aorta is a separation or tear of the intima from the media. This tear allows blood to flow not only through the original aortic flow channel (known as the true lumen), but also through a second channel between the intima and media (known as the false lumen). Aortic dissection is a life-threatening condition which can be rapidly fatal. There is debate on the optimal surgical approach for aortic arch dissection. People with ascending aortic dissection have poor rates of survival. Currently open surgical repair is regarded as the standard treatment for aortic arch dissection. We intend to review the role of hybrid and open repair in aortic arch dissection.

Objectives: To assess the effectiveness and safety of a hybrid technique of treatment over conventional open repair in the management of aortic arch dissection.

Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 8 February 2021. We also undertook reference checking for additional studies.

Selection criteria: We included randomised controlled trials (RCTs) and clinical controlled trials (CCTs), which compared the effects of hybrid repair techniques versus open surgical repair of aortic arch dissection. Outcomes of interest were dissection-related mortality and all-cause mortality, neurological deficit, cardiac injury, respiratory compromise, renal ischaemia, false lumen thrombosis (defined by partial or complete thrombosis) and mesenteric ischaemia.

Data collection and analysis: Two review authors independently screened all records identified by the literature searches to identify those that met our inclusion criteria. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of the evidence using GRADE.

Main results: We identified one ongoing study and two unpublished studies that met the inclusion criteria for the review. Due to a lack of study data, we could not compare the outcomes of hybrid repair to conventional open repair for aortic arch dissection.

Authors' conclusions: This review revealed one ongoing RCT and two unpublished RCTs evaluating hybrid versus conventional open repair for aortic arch surgery. Observational data suggest that hybrid repair for aortic arch dissection could potentially be favourable, but conclusions can not be drawn from these studies, which are highly selective, and are based on the clinical status of the patient, the presence of comorbidities and the skills of the operators. However, a conclusion about its definitive benefit over conventional open surgical repair cannot be made from this review without published RCTs or CCTs. Future RCTs or CCTs need to have adequate sample sizes and follow-up, and assess clinically-relevant outcomes, in order to determine the optimal treatment for people with aortic arch dissection. It must be noted that this may not be feasible, due to the reasons mentioned.

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Conflict of interest statement

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.

Figures

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Study flow diagram.
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD012920

References

References to studies excluded from this review

NCT00526487 {published data only}
    1. 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 {published data only}
    1. NCT00583817. Endovascular exclusion of ascending and thoracic aortic pathology. clinicaltrials.gov/ct2/show/NCT00583817 (first received 31 December 2007).
NCT01107366 {published data only}
    1. 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 {published data only}
    1. NCT01500395. Hybrid operation in thoracic aortic dissection. clinicaltrials.gov/ct2/show/NCT01500395 (first received 28 December 2011).
NCT01568320 {published data only}
    1. NCT01568320. Zenith® dissection clinical trial. clinicaltrials.gov/ct2/show/NCT01568320 (first received 2 April 2012).
NCT01704391 {published data only}
    1. NCT01704391. Haemodynamic response to aortic surgery. clinicaltrials.gov/ct2/show/NCT01704391 (first received 11 October 2012).
NCT02094300 {published data only}
    1. NCT02094300. Zenith® dissection endovascular system (STABLE I). clinicaltrials.gov/ct2/show/NCT02094300 (first received 14 September 2015).
NCT02201589 {published data only}
    1. NCT02201589. Feasibility of endovascular repair of ascending aortic pathologies. clinicaltrials.gov/ct2/show/NCT02201589 (first received 28 July 2014).
NCT02464943 {published data only}
    1. NCT02464943. Zenith® dissection endovascular system in the treatment of patients with aortic dissections. clinicaltrials.gov/ct2/show/NCT02464943 (first received 8 June 2015).
NCT02724072 {published data only}
    1. NCT02724072. Thoraflex™ Hybrid IDE Study. clinicaltrials.gov/ct2/show/NCT02724072 (first received 31 March 2016).
NCT03322033 {published data only}
    1. NCT03322033. Feasibility of endovascular repair of ascending aortic pathologies (PS-IDE). clinicaltrials.gov/ct2/show/NCT03322033 (first received 26 October 2017).
Tsukui 2002 {published data only}
    1. 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. - PubMed

References to ongoing studies

ChiCTR‐IPR‐16009372 {published data only (unpublished sought but not used)}
    1. 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 {published data only (unpublished sought but not used)}
    1. 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 {published data only (unpublished sought but not used)}
    1. 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).

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References to other published versions of this review

Kavanagh 2018
    1. 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] - DOI - PMC - PubMed

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