A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair

Abstract

Introduction:

The present standard of care to treat aortic arch pathologies is open surgical repair with cardiopulmonary bypass and deep hypothermic arrest. With approaches for total endovascular and extra-anatomic cervical debranching hybrid arch repair becoming more diverse, understanding what is considered a successful operation is prerequisite for a rigorous comparison of techniques. This review describes the specific outcomes reported, the rates of success, and the definitions of technical and clinical success in total endovascular and extra-anatomic cervical debranching hybrid aortic arch repair.

Methods:

A comprehensive search of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed. Studies with patients undergoing total endovascular or hybrid extra-anatomic cervical debranching repair of the aortic arch were included. Any publications including only patients with Ishimaru zone 2 or distal repairs were excluded from this review. Studies with less than 5 patients were excluded. Data extraction was performed by one author. Data items included were study design, procedure type, procedural details, underlying pathology, type of cervical debranching, type of endograft repair, surgical outcomes, definition of cerebrovascular events, technical success, and the definition of technical success.

Results:

Of 1754 studies screened for review, 85 studies with 5521 patients were included. By frequency, the included studies examined the following interventions: fenestrated devices, branched devices, parallel grafting. Most studies were retrospective single-institution studies. There were no randomized controlled trials. Short-term mortality and cerebrovascular events were nearly universally reported, present in 99% and 95% of studies reviewed, respectively. Only 27% of studies provided an explicit definition for cerebrovascular events. While 75% of studies reported a technical success rate, only 45% of those studies provided explicit criteria. Clinical success rates were infrequently reported, present in only 5.9% of studies reviewed.

Conclusion:

The definitions of technical success that were provided fell short of analogous defined reporting standards in nearly all studies, inflating technical success rates. Definitions of cerebrovascular events and technical success require stringent criteria to uniformly compare various methods of endovascular aortic arch repair. A societal consensus document for reporting standards of endovascular aortic arch repair would allow for higher-quality outcomes research.

Clinical Impact

Total endovascular and extra-anatomic cervical debranching hybrid operations are being increasingly utilized for complex aortic arch repair. These techniques, however, can be associated with serious complications. Currently, there is no accepted metric to define technical or report clinical outcomes. Due to the paucity of high-quality data, use of these approaches may be limited in clinical practice. This study emphasizes the need for the development of standards for reporting outcomes in endovascular aortic arch repair. Future studies can then utilize these benchmarks, whcih will allow for improved efficacy and safety in these techniques.

Keywords

endovascular aortic arch repair fenestrated arch grafts branched arch grafts extra-anatomic cervical debranching

Introduction

Open repair of aortic arch disease was first introduced by Dr. Cooley in 1955.¹ Since that time, it has become the standard of care for aortic arch pathologies. The ability to offer open repair of arch disease is limited by its morbidity and mortality. A recent study demonstrated an in-hospital mortality rate of 7.6% and permanent neurologic dysfunction of 5.7%.² Endovascular and hybrid approaches have emerged as alternative techniques for arch repair with the intent of decreasing associated morbidity and mortality while expanding the patient population that can be treated. As these less-invasive approaches become more prevalent, it is important to stringently define their outcomes and elucidate whether there are advantages over open repair. This scoping review seeks to examine the definitions of outcomes for cervical debranching hybrid arch and total endovascular arch procedures to treat zone 0 and zone 1 pathology. Of particular importance is the definition of technical success and what cerebrovascular outcomes are being reported or failing to be included in publications.

Methods

Protocol and Registration

The study protocol and search strategy are registered on the Open Science Framework at the following link: https://osf.io/2b8kp/ Ethics approval was not required for this review. Reporting of this scoping review follows the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews guidelines, and the checklist is included in Supplement 1. A scoping review strategy was chosen based on the expectation that there would be no randomized controlled trials or large studies on which to perform a meta-analysis.

Information Sources, Search Strategy, and Eligibility Criteria

MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials databases were queried on April 10, 2023. Specific search terms can be found on the Open Science Framework. Multiple searches were performed using a combination of the terms total endovascular, aortic arch, zone 1, endovascular repair, cervical debranching, hybrid aortic repair, and supra-aortic debranching. Publications in English with full text available from 2016 to 2023 were included. Any studies with strictly Ishimaru zone 2 or distal repairs were excluded. If outcomes for zone 0 and zone 1 repairs could not be clearly found within the text, the paper was excluded. This exclusion was done to focus attention on identifying the outcomes and management of the proximal arch vessels during these repairs.

Selection of Sources of Evidence

All study types were eligible for inclusion except review articles and case reports with less than 5 patients. Conference abstracts were excluded. Studies were included if they reported outcomes on total endovascular or hybrid aortic arch repair without the use of a median sternotomy or cardiopulmonary bypass. If temporary shunting or bypass was used without a perfusionist, the paper was included for analysis.

A Downs and Black checklist was completed to evaluate the quality of each source and can be seen in Supplemental Table #1.

Data Extraction Process and Data Items

Publication titles and abstracts were directly viewed from the OVID search results. Screening of the initial search results was performed by one author (MJR). Abstracts were reviewed by three authors (MJR, SI, and SDF) to be included for full-text review. After exclusion of irrelevant publications, one author (MJR) extracted data items via a data-collection form created for this study. Data items included were study design, procedure type, procedural details, underlying pathology, type of cervical debranching, type of endograft repair, surgical outcomes, cerebrovascular events, cerebrovascular event definition, technical success, and criteria for technical success.

Synthesis of Results

Each reported outcome was collated to provide an overall description of the literature. Pooled rates were calculated by multiplying the recorded rates by the population for each study and dividing the sum of the numerators by the sum of the denominators. If individual-level data were made available, the exact numerators and denominators were extracted. Kaplan-Meier estimates were excluded from pooled analysis to avoid mixing inferential and descriptive data. Overall pooled outcomes were reported.

Results

Selection and Characteristics of Sources of Evidence

Total listed search results reviewed for inclusion were 1754. Figure 1 demonstrates the review process. There were no randomized clinical trials. Twenty-seven percent (23/85) of studies were multicenter. Eighty-five percent of studies (72/85) were retrospective. Fourteen percent (12/85) compared different techniques for arch repair. The articles were published in 26 different journals. The most common journals were the Journal of Vascular Surgery (19%, 16/85), the Journal of Endovascular Therapy (13%, 11/85), and the European Journal of Vascular and Endovascular Surgery (9%, 8/85).

Types of Intervention

Seventeen percent (14/85) of papers included multiple types of interventions in their study. The most described intervention was a fenestrated arch device at 38.8% (33/85). Branched devices were described in 27.1% of papers (23/85), parallel grafting in 23.5% of papers (20/85), and a combined fenestrated/branched device in 7.1% of papers (6/85). Cervical debranching with a standard TEVAR (thoracic endovascular aortic repair) graft was described in only 6.0% (6/85) of papers. One paper (1.2%) described micropore endografts.

Within those descriptions, 24.7% (21/85) of studies involved an intraoperative or back-table modification. Nineteen percent (16/85) of studies reported outcomes of back-table physician modifications of endografts. Four percent (3/85) described in situ needle fenestration, and 2.4% (2/85) described in situ laser fenestration. Of the 69 studies that described the underlying pathology treated, 82.6% (57/69) treated multiple pathologies. Pathologies treated included aortic arch aneurysm, acute type B aortic dissection, chronic type B aortic dissection, retrograde type A dissection, intramural hematoma, penetrating atherosclerotic ulcer, post-ascending repair anastomotic aneurysm, trauma, and type IA endoleaks.

Reported Outcomes

Herein, we review reported outcomes of relevance. Notably, there is an absence of patient-centered outcomes owed, in part, to the infancy of these techniques. Table 1 identifies all studies included and select outcomes they reported.

Table 1.

Included Studies and Selected Outcomes.

Author	Year	30-Day mortality rate	365-Day mortality rate	30-Day aortic mortality rate	365-Day aortic mortality rate	Clinical success rate	30-Day CVA rate	365-Day CVA rate	Technical success rate
Lee et al³	2023	0.0%	.	0.0%	11.0%	.	0.0%	.	100.0%
Planer et al⁴	2023	7.1%	10.7%	0.0%	0.0%	.	3.6%	7.1%	100.0%
Isernia et al⁵	2023	1.3%	.	0.0%	.	95%	3.9%	.	97.4%
Fu et al⁶	2023	0.0%	.	.	.	.	2.3%	2.3%	.
Mougin et al⁷	2023	5.6%	.	.	.	.	5.6%	.	100.0%
Chen et al⁸	2023	3.2%	.	2.8%	.	.	.	.	.
Tian et al⁹	2023	1.4%	.	.	.	.	1.4%	.	.
Teng et al¹⁰	2023	0.0%	3.1%	.	.	.	0.0%	0.0%	100.0%
Luo et al¹¹	2023	5.3%	.	.	.	.	1.8%	.	.
Luo et al¹²	2023	3.1%	6.3%	.	.	.	0.0%	0.0%	100.0%
Squizzato et al¹³	2023	0.0%	12.5%	.	.	.	12.5%	.	100.0%
Eleshra et al¹⁴	2022	7.1%	KM	.	.	.	7.1%	.	92.9%
Chastant et al¹⁵	2022	2.0%	.	2.0%	.	.	10.0%	.	100.0%
Juan et al¹⁶	2022	4.8%	KM	.	.	.	7.9%	.	100.0%
Kudo et al¹⁷	2022	2.5%	13.6%	2.5%	2.5%	.	10.0%	.	100.0%
Dueppers et al¹⁸	2022	9.0%	18.0%	.	.	30%	6.0%	.	37.0%
Toya et al¹⁹	2022	0.0%	.	.	.	.	0.0%	.	100.0%
Canaud et al²⁰	2022	2.0%	.	.	.	.	4.0%	.	97.0%
D’Onofrio et al²¹	2022	7.0%	11.0%	0.0%	0.0%	.	7.0%	7.0%	.
Liang et al²²	2022	0.0%	11.0%	.	.	.	22.0%	33.0%	100.0%
Zhang et al²³	2022	0.0%	.	.	.	.	0.0%	.	100.0%
Li et al²⁴	2022	1.2%	.	.	.	.	0.9%	.	84.6%
Lu et al²⁵	2022	6.5%	.	.	.	.	3.2%	.	.
Yen et al²⁶	2022	9.1%	.	.	.	.	.	.	.
Hauck et al²⁷	2022	.	KM	.	.	.	7.4%	.	98.1%
Wu et al²⁸	2022	0.7%	2.2%	.	.	.	4.7%	.	74.5%
Kishimoto et al²⁹	2022	0.0%	KM	.	.	.	9.5%	.	100.0%
Torrealba et al³⁰	2022	4.2%	.	.	.	.	8.3%	.	.
Gao et al³¹	2022	0.0%	.	.	.	.	8.3%	.	95.2%
Barnes et al³²	2022	10.0%	20.0%	.	.	.	10.0%	.	.
Li et al³³	2021	2.5%	4.0%	.	.	94%	2.4%	.	98.6%
Dake et al³⁴	2021	0.0%	22.0%	0.0%	0.0%	.	22.0%	22.0%	100.0%
Tenorio et al³⁵	2021	5.0%	KM	.	KM	.	5.1%	.	100.0%
Li et al³⁶	2021	6.3%	6.3%	6.3%	6.3%	.	6.3%	.	100.0%
Zhang et al³⁷	2021	2.0%	.	.	.	.	0.0%	.	.
Chassin-Trubert et al³⁸	2021	2.0%	6.0%	0.0%	0.0%	.	4.0%	.	94.0%
Charbonneau et al³⁹	2021	0.0%	.	.	.	.	0.0%	.	100.0%
Czerny et al⁴⁰	2021	9.3%	.	.	.	.	25.6%	.	.
Oztas et al⁴¹	2020	0.0%	14.0%	0.0%	0.0%	.	0.0%	.	86.0%
Yamashiro et al⁴²	2020	6.3%	KM	.	.	.	3.6%		.
Chen et al⁴³	2020	4.6%	10.8%	.	.	.	1.9%	.	.
Kuo et al⁴⁴	2020	4.0%	8.0%	.	.	.	0.0%	.	96.0%
Soares et al⁴⁵	2020	14.3%	KM	.	.	.	8.6%	.	.
Tsilimparis et al⁴⁶	2020	6.0%	6.0%	.	.	.	6.0%	.	100.0%
Tsilimparis et al⁴⁷	2020	9.0%	22.0%	.	.	.	9.0%	.	95.0%
Sato et al⁴⁸	2020	0.0%	.	.	.	.	11.7%	.	97.3%
Zhang et al⁴⁹	2020	7.1%	.	.	.	.	.	.	.
Shu et al⁵⁰	2020	0.9%	KM	.	.	.	1.7%	.	99.6%
Luo et al⁵¹	2020	0.0%	KM	.	.	.	0.0%	.	96.0%
Furuta et al⁵²	2020	3.0%	.	.	0.5%	.	6.0%	.	91.0%
Fernandez-Alonso et al⁵³	2020	7.1%	7.1%	0.0%	0.0%	.	7.1%	.	100.0%
Li et al⁵⁴	2020	8.3%	.	.	.	.	8.3%	.	.
van der Weijde et al⁵⁵	2019	18.0%	.	.	.	.	36.0%	.	100.0%
Gandet et al⁵⁶	2019	0.0%	.	0.0%	.	.	7.6%	.	.
Konstantinou et al⁵⁷	2019	7.6%	.	.	.	.	6.6%	.	100.0%
Law et al⁵⁸	2019	9.0%	27.0%	.	.	.	9.0%	.	100.0%
Tsilimparis et al⁵⁹	2019	5.5%	18.0%	.	.	.	11.0%	.	98.0%
Canaud et al.⁶⁰	2019	6.0%	.	.	.	.	3.0%	.	100.0%
Canaud et al⁶¹	2019	0.0%	.	0.0%	.	.	5.9%	.	.
Ferrer et al⁶²	2019	16.7%	.	.	.	.	25.0%	.	95.8%
Zhao et al⁶³	2019	.	.	.	.	.	0.0%	.	100.0%
Zhang et al⁶⁴	2019	0.8%	.	.	.	.	1.9%	.	100.0%
Kuo et al⁶⁵	2019	0.0%	15.4%	0.0%	.	.	0.0%	.	100.0%
Fukushima et al⁶⁶	2019	0.0%	KM	0.0%	KM	.	4.2%	.	95.8%
Zhu et al⁶⁷	2019	10.0%	.	.	.	.	0.0%	.	90.0%
Toya et al⁶⁸	2019	0.0%	.	.	.	.	.	.	100.0%
Tsilimparis et al⁶⁹	2018	5.0%	11.0%	5.0%	.	.	5.0%	.	95.0%
Ferrer et al⁷⁰	2018	28.6%	.	14.3%	.	.	14.3%	.	100.0%
Liu et al⁷¹	2018	0.0%	.	.	.	.	4.3%	.	100.0%
Clough et al⁷²	2018	10.0%	.	.	.	.	6.7%	.	90.0%
Shahverdyan et al⁷³	2018	16.7%	KM	.	.	.	13.3%	.	90.0%
Yoshitake et al⁷⁴	2017	3.3%	.	.	.	.	8.5%	.	.
Hori et al⁷⁵	2017	5.0%	KM	.	.	.	3.0%	.	.
Yuri et al⁷⁶	2017	3.7%	.	.	.	89%	3.7%	.	100.0%
Pecoraro et al⁷⁷	2017	12.2%	KM	.	.	.	4.9%	.	95.1%
Canaud et al⁷⁸	2017	5.6%	.	.	.	.	2.8%	.	100.0%
Vokresensky et al⁷⁹	2017	3.7%	KM	.	.	.	11.1%	.	88.9%
Faure et al⁸⁰	2016	3.0%	9.0%	.	.	.	6.0%	.	97.0%
Kang et al⁸¹	2016	5.7%	12.7%	.	.	.	5.7%	.	77.1%
Shiraev et al⁸²	2016	0.0%	.	.	.	.	14.3%	.	.
Huang et al⁸³	2016	0.0%	0.0%	.	.	.	7.4%	.	100.0%
Spear et al⁸⁴	2016	14.2%	.	.	.	.	0.0%	.	71.0%
Abdallah et al⁸⁵	2016	10.0%	.	.	.	.	10.0%	.	100.0%
Tsilimparis et al⁸⁶	2016	10.3%	.	.	.	.	10.3%	.	96.6%
Bosiers et al⁸⁷	2016	9.5%	.	0.0%	KM	.	4.2%	.	89.5%

Mortality

All but one study (98.8%) reported 30-day mortality. The pooled 30-day mortality was 3.4% with a range from 0 to 28.6%. Half of the studies reviewed (43/85) reported 1-year mortality. A large minority of those studies (14/43) reported Kaplan-Meier 1-year mortality estimates only. The pooled 1-year mortality was 7%, with a range from 0 to 27%. Thirty-day aortic mortality was reported in 25.6% (22/85) of studies, with a pooled rate of 1.5% and a range of 0 to 14.3%. One-year aortic mortality was reported in 15.3% (13/85) of studies, with a pooled rate of 1% and a range from 0 to 11%.

Neurologic outcomes

Of the total number of studies, 95.3% (81/85) a 30-day stroke rate. Only 27.2% (22/81) of those studies provided explicit criteria for cerebrovascular events. Of those studies, 36.4% (8/22) required clinical symptoms confirmed with changes on computed tomography (CT) or magnetic resonance imaging (MRI). Of the reported cerebrovascular events, 23.5% (19/81) reported distinctions either between major and minor or disabling and non-disabling strokes, although none of these studies strictly defined the criteria for each. TIAs were reported or included in the definition of a cerebrovascular event in 17.3% (14/81) of studies. The pooled rate of cerebrovascular events was 4.3%, with a range from 0 to 36%. One-year stroke rates were reported in 9.4% (8/85) of studies. The pooled rate was 5.4%, with a range from 0 to 33%. Only two studies included modified Rankin scores. Of the total number of studies, 72.9% (62/85) reported spinal cord ischemia rates. The pooled rate was 0.8%, with a range from 0 to 12%. Length of coverage was not recorded in this study.

Additional adverse events

Rates of retrograde type A dissection were reported in 41.2% of studies (35/85). The pooled rate was 2.2%, with a range from 0 to 16.7%. Other adverse events were reported in 49.4% of cases (42/85).

Technical characteristics and outcomes

Sixty percent (51/85) of studies described general approaches to or specific rates of vessels accessed. Interventions to aid deployment of the endograft were reported in 42.4% (36/85) of studies. Of the total number of studies, 70.6% (60/85) described general or specific procedures for cervical debranching or revascularization of the supra-aortic branches.

The pooled technical success rate was 94.7%, with a range from 37% to 100%. Only 75.3% (64/85) of studies reported technical success. Of the 65 studies that reported technical success, more than half (34/66) had a success rate of 100%. Only 29 studies explicitly stated a definition of technical success. Table 2 tabulates the technical success criteria reported and their frequency. Five studies (5.75%) reported clinical success with a pooled rate of 91%, with a range from 30% to 95%. Four studies provided explicit definitions for clinical success. The definitions included technical success plus freedom from a range of major complications including death, stroke, aneurysm rupture, or new thoracic pathology.

Table 2.

Criteria for Technical Success.

Publication	Technical success rate	Successful arterial access	Endograft deployment at intended location	Absence of type I endoleak	Absence of type III endoleak	No endoleaks to 30 days	Absence of any endoleak at completion	Patent aortic branches at completion	Absence of conversion to open or intraoperative death	No adverse events
Lee et al³	100.0%	0	1	0	0	0	0	1	0	0
Isernia et al⁵	97.4%	0	1	1	1	0	0	1	0	0
Eleshra et al¹⁴	92.9%	0	1	0	0	0	1	1	0	0
Chastant et al¹⁵	100.0%	0	1	1	0	0	0	1	0	0
Juan et al¹⁶	100.0%	0	1	0	0	0	0	1	1	0
Dueppers et al¹⁸	37.0%	1	1	1	1	1	0	1	0	0
Toya et al¹⁹	100.0%	0	1	1	1	0	0	1	0	0
Hauck et al²⁷	98.1%	0	1	1	1	0	0	0	1	0
Wu et al²⁸	74.5%	0	1	0	0	0	1	1	0	0
Gao et al³¹	95.2%	0	1	0	0	0	0	1	0	0
Li et al³³	98.6%	0	1	0	0	0	1	1	0	0
Tenorio et al³⁵	100.0%	0	1	0	0	0	0	1	0	0
Kuo et al⁴⁴	96.0%	0	1	0	0	0	1	1	0	1
Tsilimparis et al⁴⁶	100.0%	0	1	1	1	0	0	1	1	0
Luo et al⁵¹	96.0%	0	1	0	0	0	0	1	0	0
Furuta et al⁵²	91.0%	0	1	0	0	0	0	0	0	1
Fernandez-Alonso et al⁵³	100.0%	0	1	0	0	0	1	1	0	0
Zhao et al⁶³	100.0%	0	0	1	0	0	0	0	0	0
Zhang et al⁶⁴	100.0%	0	1	1	0	0	0	1	0	0
Kuo et al⁶⁵	100.0%	0	1	0	0	0	0	1	0	0
Fukushima et al⁶⁶	95.8%	0	0	1	1	0	0	1	0	0
Zhu et al⁶⁷	90.0%	0	1	1	1	0	0	0	1	0
Ferrer et al⁷⁰	100.0%	0	1	1	1	0	0	0	0	0
Clough et al⁷²	90.0%	0	1	1	1	0	0	1	1	0
Yuri et al⁷⁶	100.0%	0	1	0	0	0	0	0	0	0
Pecoraro et al⁷⁷	95.1%	1	1	1	1	0	0	0	0	0
Vokresensky et al⁷⁹	88.9%	0	1	1	1	0	0	0	0	0
Kang et al⁸¹	77.1%	1	1	1	1	0	0	0	1	0
Huang et al⁸³	100.0%	0	1	0	0	0	0	1	0	0
Total	.	10.3% (3/29)	93.1% (27/29)	51.7% (15/29)	41.4% (12/29)	3.45% (1/29)	17.2% (5/29)	69.0% (20/29)	20.7% (6/29)	6.9% (2/29)

Immediate endoleak was reported in 43.5% (37/85) of studies, with a pooled rate of 18.5%. Thirty-day endoleak was reported in 32.9% (28/85) of studies with a pooled rate of 9.8%. Thirty-day target patency was reported in 41.2% (35/85) of studies with a pooled rate of 99.6%. Thirty-day rates of reintervention were reported in 50.6% (43/85) of studies with a range of 0 to 45% and a pooled rate of 3.9%. One-year rates of reintervention were reported in 22.4% (19/85) of studies with a range from 0 to 33% and a pooled rate of 12.8%.

Discussion

Summary of Evidence

The outcomes and success rates varied greatly among different studies. The definition and inclusion of different outcomes and of success varied greatly as well. Technical success, when explicitly defined, typically involved a combination of several of the 10 criteria listed in Table 2. While there is no current document from the Society of Vascular Surgery or the Society for Thoracic Surgery on reporting standards of endovascular arch repair, there are precedents on how to define technical success.^88,89 In the reporting standards for TEVAR, Fillinger et al include four criteria: successful arterial access, successful deployment of endograft at intended location, absence of type I or type III endoleak, and patent endograft without a pressure gradient >10 mm Hg. In the reporting standards for endovascular aortic repair involving the renal-mesenteric arteries, Oderich et al include five criteria to meet for technical success: successful arterial access (remote, percutaneous, open conduit), successful delivery and deployment of endograft and all components, successful side-branch catheterization and placement of bridging stents with restoration and maintenance of flow in intended target vessels, absence of type I or type III endoleaks at completion and beyond 30 days, and patency of all aortic modular stent graft components and side-branch components. The criteria for technical success as outlined by Oderich et al demonstrate the increased complexity of an endovascular repair involving branches and how far technology has advanced since the reporting standards by Fillinger et al.

Comparing outcomes with open aortic surgery and hybrid repair requiring sternotomy will be the upcoming challenge as these technologies advance. There are no analogous definitions for technical success given that if there is a failure of technique in open cases, the patient does not typically make it off the table. However, multiple publications have attempted to codify standards and outcomes. The International Aortic Arch Surgery Study Group published a consensus statement in 2014 with the intent of standardizing clinical end points.⁹⁰ In part based off the work of Dindo et al, they proposed different gradings of clinical complications, both overall and within organ-based system. Within each organ system, there were individually defined morbidities. For neurologic endpoints, a patient could suffer a global, focal, or spinal neurological deficit with the severity and duration of these events to determine a grading of I to IV. In a collaborative publication detailing treatment recommendations for aortic arch intervention, the European Association for Cardio-Thoracic Surgery and the European Society for Vascular Surgery noted “although reporting standards in classical adult cardiac or vascular surgery have widely been established, there is work to do in the aortic sector in particular when it comes to treatment of the aortic arch.”⁹¹ The consensus document then refers to Fillinger et al as the reporting standards for TEVAR and fails to discuss reporting standards for open aortic repairs. Without analogous open reporting standards, even if endovascular and cervical hybrid arch repair adopt a uniform reporting methodology, comparison to the gold standard of care will remain difficult.

Only 75.3% (64/85) of studies reported a technical success rate, and only 45% of those studies (29/64) explicitly defined technical success. Dueppers et al¹⁸ was the only study to define technical success in accordance with Oderich et al. Notably, their technical success rate was the lowest of all the studies reviewed at 37.0%.

It is important to note that two thirds of the studies included (64.7%, 55/85) were published before or in the same year, 2021, as Oderich et al. Only three studies included successful arterial access in their criteria for technical success. The importance of the access criterion in these procedures cannot be understated. Many of these procedures require exposure of multiple vessels for access. Including freedom from access-related adverse events to achieve technical success is necessary to compare outcomes fairly and uniformly between different modalities of arch repair. Otherwise, researchers can easily misconstrue the success of a particular modality by failing to account for the sequalae of the associated steps.

Not included within the work of Oderich et al. but relevant to aortic arch repair is the success of any required cervical debranching procedures. For example, a patient may undergo a right carotid to left subclavian bypass with reimplantation of the left carotid onto the graft and maintain supra-aortic branch patency but experience a cranial nerve injury during the procedure. This patient, assuming other criteria were met, would still be counted as a technical success within the Oderich et al. criteria despite a technical failure in the debranching procedure. Without a comprehensive definition for technical success in endovascular aortic arch repair and without adherence to the definition, it will be impossible to accurately measure and compare the success of different techniques.

Within this scoping review, the omission of important common criteria in many of these studies precludes comparison of technical success across modalities. Thus, the pooled technical success rate of 94.7% is likely overstated. Reporting of the types of cervical debranching and associated adverse events should be included in any discussion of technical success. With only 70.6% (60/85) of these studies reporting their approach, the state of the literature leaves much to be desired. Incorporating adverse events and technical failures of debranching procedures into the technical success criteria for aortic arch repair would make the definition more reflective of the extended process required to achieve success in these complicated procedures.

Limitations

A scoping review takes a high-level view of many studies in an area of burgeoning research. The main limitation of this study is the lack of uniform outcome definitions in techniques to address aortic arch pathology. More prospective studies into the outcomes of these procedures with rigorously high standards for success will allow surgeons and patients to accurately assess the risks and benefits of endovascular aortic arch repair.

Another significant limitation of this study is the heterogeneity of the pathologies addressed in the sample studies. The heterogeneity of the pathology as well as the methodology of a scoping review restrict the applicability of these pooled rates to any specific clinical situation.

Conclusions

Short-term mortality and cerebrovascular events are nearly universally reported, demonstrating endovascular aortic arch repair to be a feasible option for pathologies in zone 0 and zone 1. However, definitions of technical success and reporting of neurologic events varied greatly among studies. Few studies reported clinical success, perhaps the most important criterion from a patient’s perspective. These shortcomings may be addressed by the development of societal reporting standards for extra-anatomic cervical debranching and endovascular aortic arch repair.

Supplemental Material

sj-docx-1-jet-10.1177_15266028241271679 – Supplemental material for A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair

Supplemental material, sj-docx-1-jet-10.1177_15266028241271679 for A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair by Matthew J. Rossi, Sadia Ilyas, Steven D. Abramowitz, Simon De Freitas, Maxwell A. Hockstein, Krystal C. Maloni, Christian Shults and Javairiah Fatima in Journal of Endovascular Therapy

Supplemental Material

sj-docx-2-jet-10.1177_15266028241271679 – Supplemental material for A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair

Supplemental material, sj-docx-2-jet-10.1177_15266028241271679 for A Scoping Review of Definitions of Success in Endovascular Aortic Arch Repair by Matthew J. Rossi, Sadia Ilyas, Steven D. Abramowitz, Simon De Freitas, Maxwell A. Hockstein, Krystal C. Maloni, Christian Shults and Javairiah Fatima in Journal of Endovascular Therapy

Footnotes

Authors’ Note

I, Matthew J. Rossi, MD, on behalf of all the authors listed below affirm that this manuscript titled below has not been previously published nor has any part currently submitted for publication. All authors have read and approved the manuscript.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Dr. Abramowitz serves on the Gore Medical Advisory Board.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Matthew J. Rossi

Maxwell A. Hockstein

Supplemental Material

Supplemental material for this article is available online.

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