Endovascular repair of acute complicated type B aortic dissection—systematic review and meta-analysis of long-term survival and reintervention

Introduction

Thoracic endovascular aortic repair (TEVAR) is considered the first-line therapy in the repair of acute, complicated type B aortic dissection (AC-BAD), with favorable outcomes over that of open repair and medical management in short-term analyses (1). Given the difficulty of designing randomized clinical trials to evaluate the effectiveness of endovascular and open repair, long-term outcome data on this important surgical cohort, particularly with respect to prosthesis endurance, hemodynamic remodeling and survival outcomes, is limited. This systematic review and meta-analysis provide a complete aggregation of reported long-term survival and freedom from reintervention of AC-BAD patients based on the existing literature.

Methods

Literature search strategy

This review was performed in accordance with PRISMA recommendations and guidance (2). Electronic searches were performed on PubMed, Scopus, and EMBASE/Medline from dates of database inception to January 2021, using ((“endovascular” OR “minimally invasive” OR “TEVAR” OR “thoracic endovascular aortic repair” OR “thoracic endovascular aneurysm repair”) AND (“type B” OR “Stanford type B” OR “DeBakey type III” OR “DeBakey III”) AND (“aortic dissection”) AND (“acute”) AND (“complicated”)) as search terms. After removal of duplicate records, abstracts and titles were screened and the appropriate studies meeting the inclusion criteria detailed below were selected for full-text review. Four independent authors individually assessed the eligibility of the selected papers (AWS, HK, BM, CCH). A PRISMA diagram of the search strategy is presented in Figure S1. Additional references for discussion were included via a reference list search or via targeted database searches. This was deemed appropriate if studies were poorly indexed and did not appear outside of targeted searches (i.e., as is the case with early 2000’s papers).

Inclusion and exclusion criteria

Studies were included for review if they had at least 20 patients in their study cohorts where TEVAR was explicitly utilized in the management of acute, complicated type B aortic dissection, with ‘complicated’ dissection defined as aortic rupture and/or the presence of organ malperfusion syndromes. Non-English studies, reviews, case series, conference and paper abstracts, editorials, letters and opinions were all excluded. Studies were also excluded if they failed to present baseline patient characteristics, dissection type, time course and definition of presentation (e.g., acute vs. chronic), clinical outcomes and/or endpoints between their cohorts. Reoperation cohorts, either treated via TEVAR or conventional open/hybrid approaches were not included. Failure to state acuity (i.e., acute, subacute, chronic) or complexity (e.g., complicated vs. uncomplicated) resulted in exclusion. Studies analyzing physician-customized stent grafts were also not included given the increased probability of heterogeneity (i.e., variable graft hemodynamics, differing deployment strategies, etc.). If a study was a part of an institutional series, the most recent study was taken for analysis. If studies were not available for full-text review, they were excluded (n=0). Registry reviews were not included given the inability to preclude patient overlap.

Primary and secondary endpoints, study quality appraisal

The primary endpoints were mortality (all reported time intervals) and freedom from reintervention. The secondary endpoints were rates of postoperative complications (e.g., stroke, cord ischemia, endoleak, etc.). Study quality was assessed with the Delphi Study Quality Appraisal tool (Table S1) (3).

Statistics

Baseline cohort characteristics and postoperative details were extracted by three independent researchers (AWS, HK, BM). Discrepancies were reviewed by the senior researcher (AWS) until a consensus was reached. Statistical analysis was carried out using Review Manager (Version 5.3. The Cochrane Collaboration, 2014) and R (Version 4.1.1. R Core Team, Vienna, Austria) using meta-analysis of proportions and means with a random-effects model. Values were considered statistically significant at P values of less than 0.05. Kaplan-Meier survival curves were digitized where presented, and an algorithmic computational tool was utilized, as outlined by Guyot and colleagues, to derive individual patient data (4). Censoring was assumed to be constant, unless the curve had a long follow-up of only minimal patients, in which case, censoring was manually entered. Events and censoring data were compiled for the entire patient cohort and overall survival curves were produced as per the Kaplan-Meier method using IBM SPSS Statistics 26 (IBM Corp. Released 2017; IBM SPSS Statistics for Macintosh, Version 26.0. Armonk, NY, USA: IBM Corp). Where studies had broken their cohorts into subgroups (e.g., DeBakey Type IIIa and Type IIIb), individual KM curves were generated for these first and then subsequently merged, prior to being included in the whole cohort analysis. Studies that failed to report numbers at risk, or had data points obscured by censoring brackets, were excluded. These measures were applied in order to reduce the heterogeneity of the population and increase the validity of the findings, as per the recommendations of Guyot et al. (4).

Results

Baseline study characteristics

A total of 2,812 references were identified in the literature search for review. Following application of the selection criteria and reference list searches, 46 papers were identified for inclusion [see Ref. (5-29) and Ref. (30-50) for details]. Twenty-six of those studies provided KM curves for meta-analysis. Baseline cohort characteristics, including reporting frequency, are presented in Table 1. A total of 2,565 patients were identified, of whom 1,920 (75%) were male. The mean age of the cohort was 59.8±5.8 years. The median number of patients per study was 43 (interquartile range, 33–60). Patient comorbidities were variably reported, ranging from 20% to 89% (Table 1). The majority of reported studies were from North American centers (18/46), with the remainder drawn from single European (17/46) and Chinese (11/46) centers. 57 percent of studies (26/46) were rated as high quality according to the Delphi Quality Assessment Criteria, and the remainder were classified as either moderate quality (18/46) or low quality (2/46) (Table S2) (3). Early postoperative outcome reporting ranged from 17–72%, with reintervention being the most frequently cited (Table 2). Prosthesis type was reported in 70% (32/46) of studies with Medtronic, Gore Medical and Cook Medical variants being used most frequently.

Post-procedural survival and freedom from reintervention

Actuarial survival at 2, 4, 6 and 10 years was 87.5%, 83.2%, 78.5% and 69.7%, respectively (Figure 1). Freedom from all secondary reintervention at 2, 4, 6, 8 and 10 years was 74.7%, 69.1%, 65.7%, 63.9% and 60.9%, respectively (Figure 2). Initial technical success was achieved in 96.3%±3.7% of total cases. When accounting for study quality (i.e., high only), actuarial survival at 2, 4, 6 and 8 years was 85.4%, 79.1%, 69.8% and 63.1%, respectively (Figure S2). Freedom from all secondary reintervention at 2, 4, 6 and 8 years was 73.2%, 67.6%, 63.7% (maintained), respectively (Figure S3). All values were statistically significant.

Figure 1 Post-operative survival in AC-BAD in endovascular repair. AC-BAD, acute complicated type B aortic dissection.

Figure 2 Freedom from reintervention in AC-BAD in endovascular repair. AC-BAD, acute complicated type B aortic dissection.

Discussion

Since the adoption of endovascular repair in the management of patients with type B aortic dissection throughout the early 2000s, a number of studies have illustrated superior perioperative and short-term outcomes compared with traditional open surgical repair (51-53). In spite of these encouraging short- and mid-term results, the long-term outcomes of endovascular repair have remained elusive, with variable mortality rates based on limited actuarial analyses. Additionally, the advantages of endovascular repair are often undermined in the literature by higher rates of reintervention compared to open surgical repair, primarily due to prosthesis endoleak, false lumen perfusion, aortic dilatation and retrograde dissection.

The present systematic review identified 46 studies encompassing 2,565 patients with acute, complicated type B aortic dissection who underwent endovascular repair and were assessed for early post-procedural complications, long-term survival and freedom from reintervention. Meta-analysis found encouraging long-term results, with a survival rate extended to 10 years of 69.7%. Significant incidence of reoperation is to be expected, however, with rates of freedom from reintervention at 10 years of 60.9%. When accounting for study quality, actuarial survival in the early years following the initial procedure remained comparable to whole-cohort rates, though rates of mortality increased modestly from 6 years onwards. This is likely to be reflective of reduced selection bias and lost-to-follow-up rates. Rates of freedom from secondary reintervention remained unchanged in the subgroup analysis throughout the follow-up period.

Excessive stent oversizing, along with bare-spring stent graft positioning in the proximal landing zone, large aortic dilatation and anticoagulant therapy were factors associated with reintervention in the most recent follow-up studies (54,55). Encouragingly, several reports have illustrated that reintervention is usually managed endovascularly, sparing patients from open surgical intervention (30). Neurologic complications and spinal cord ischemia remain some of the most devastating early adverse events of endovascular repair, though rates remain lower in comparison to surgical repair, as identified in previous meta-analyses (52). This study illustrated that the risk of stroke, cord ischemia, acute coronary syndromes and endoleak is similar to that reported in previous analyses from the early TEVAR era (52,56). Retrograde dissection fortunately remains an uncommon complication at 3%, consistent with the previous literature findings of 1–3% (57).

Limitations

Overall, the current literature and present analysis illustrate that TEVAR can be performed with encouraging long-term survival results. However, important questions remain to be answered with respect to long-term morbidity, mortality and cost-effectiveness of TEVAR after secondary reintervention. Scant data exists surrounding mid- to late-term postoperative complications, which remains an ongoing issue with the literature more broadly. Additionally, thorough long-term morphologic follow-up studies remain lacking in elucidating the outcomes of this important surgical population. Data from 1- to 3-year follow-up illustrate favourable remodeling with total false lumen thrombosis and no difference in outcome between acute and chronic complicated type B aortic dissection, though past this time interval morphology data is limited (16,29,32).

Examining differences in type IIIa and type IIIb would also yield valuable data, with more favourable outcomes tending to be reported in IIIa cohorts, with better false lumen thrombosis versus IIIb cohorts (31). A considerable degree of heterogeneity should be expected given most studies did not delineate between these subtypes. Additionally, very few studies with substantive cohort sizes comparing endovascular repair with open surgery head-to-head exist, with most large registry studies suffering from a lack of pathology-specific reporting. Often, outcomes of type A and type B aortic dissection or acute and chronic acuity are aggregated, with no separate data presented for each of these disparate pathologies (58). A sizable proportion of patients (14%) also received previous cardiac surgery, which raises concern for patient selection bias. Other confounding variables, such as stent-graft make, generation, length of stent-graft coverage and adjunctive procedures could not be accounted for given limited reporting.

Future research and clinical direction

Following additional investigation into morbidity, mortality and cost-effectiveness of acute, complicated reintervention cohorts, examining endovascular repair in the context of acute uncomplicated aortic dissection has been raised as potentially fruitful by recent studies (20). The Investigation of Stent Grafts in Aortic Dissection (INSTEAD) trial illustrated endovascular repair in uncomplicated aortic dissection failed to improve 2-year survivability despite favourable aortic remodeling, findings reinforced by the more recent Acute Dissection: Stent Graft or Best Medical Therapy (ADSORB) trial (59,60). In recent years, this established boundary is beginning to shift, as long-term follow-up data comparing optimal medical therapy and TEVAR in uncomplicated cohorts is illustrating inferior outcomes in those managed with medical therapy alone (61).

Conclusions

This systematic review and meta-analysis involved the aggregation of survival outcomes and rates of freedom from reintervention in patients managed with TEVAR for acute, complicated type B aortic dissection. TEVAR is associated with promising long-term survival extended to 10 years, though rates of freedom from reintervention remain an ongoing point for improvement, and requires additional analysis in the way of morbidity, mortality and cost-effectiveness. To the authors’ knowledge, this is the only study to have aggregated long-term mortality and freedom from reintervention in this important surgical cohort. In the absence of randomized controlled trials comparing endovascular with open repair in the setting of acute, complicated type B aortic dissection, the findings herein represent the highest level of clinical evidence on this issue.

Acknowledgments

Funding: None.

Footnote

Conflicts of Interest: The authors have no conflicts of interest to declare.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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