Abstract
Background
There is a lack of consensus on the benefit of early thoracic endovascular aortic repair (TEVAR) over medical management for uncomplicated acute type B aortic dissection (aTBAD). The aim of this study is to compare readmissions of TEVAR versus medical management as the initial treatment strategy for uncomplicated aTBAD using the Nationwide Readmissions Database (NRD).
Methods
The NRD was created under the Healthcare Cost and Utilization Project, comprising over half of the U.S. inpatient population. Patients admitted for uncomplicated aTBAD were queried from the NRD from 2016 to 2018. Risk of index admission mortality, spinal cord ischemia, stroke, and overall major complication; 90-day readmission and 90-day treatment failure, between TEVAR and medical management alone.
Results
A total of 12,645 patients with an uncomplicated aTBAD were identified (TEVAR 12% and medical management 88%). Overall major complications during index admission were higher in the medical management group (27% vs 40%, p < .0001). On multivariate analysis TEVAR was associated with lower mortality (OR: 0.47, p < .0001), but a significantly higher rate of spinal cord ischemia (OR: 2.49, p < .0001), with no difference in stroke (OR: 0.93, p = .73). 90-day readmission rates were high but were not significantly different between treatment types (22% vs 25%, OR: 0.88, p = .14). Similarly, TEVAR was not associated with a lower rate of 90-day treatment failure (OR: 0.61, p = .22). Four TEVAR (0.3%) and 40 medical management (0.5%) patients were readmitted for treatment failure due to retrograde type A dissection.
Conclusions
TEVAR for uncomplicated aTBAD was not associated with a lower 90-day readmission rate. Similarly, TEVAR was not associated with a lower rate of 90-day treatment failure. These findings provide further evidence to the equipoise of treatment options and support the need for the randomized trials currently ongoing in the U.S. and Europe investigating outcomes of TEVAR versus medical management for the treatment of uncomplicated aTBAD.
Keywords
Introduction
Historically, acute type B aortic dissections (aTBAD) have been empirically treated with optimal medical management (OMT) via impulse control to lower the heart rate and blood pressure. This widely accepted standard of care came from early findings of the International Registry of Acute Aortic Dissection (IRAD) in 2000 showing in-hospital mortality rates for medically treated aTBAD was 10.7% while those treated surgically was 31.4%. 1 However, later IRAD results showed that medically managed patients had poor long-term outcomes, highlighting the need for reevaluation of how to best treat aTBAD. 2
After early studies showing impressive results using thoracic endovascular aortic repair (TEVAR) to treat complicated aTBAD, TEVAR has been increasingly used to treat uncomplicated aTBAD (uaTBAD). 3 Several studies have shown that TEVAR and OMT have comparable in-hospital mortality, while having a high likelihood of inducing thrombosis of the false lumen.4–7 Although the 2014 European Society of Cardiology (ESC) guidelines on aortic diseases disclosed evidence supporting the early use of TEVAR for uaTBAD, it was insufficient for a recommendation, emphasizing the lack of consensus on management. 8 Early TEVAR has been shown to have decreased rates of aneurysmal degeneration in the stented aorta, need for reintervention, and is more efficacious than TEVAR performed in the chronic phase of TBAD.4–7,9–11 Outcomes of TEVAR also vary based on the presence of a complicated TBAD, high-risk features, and dissections extending beyond the aorta.12–16 Despite these potential benefits, studies showed continued degeneration of the visceral aorta requiring further interventions.17–21 Additionally, early TEVAR exposes patients to procedural risks such as stroke, spinal cord ischemia (SCI), retrograde type A aortic dissection (TAAD), and complications associated with lumbar drain placement.22–27 Indeed, worse outcomes have been observed in early TEVAR than in sub-acute or chronic phases.28,29 TEVAR’s impact on hospital length of stay and costs also remains an area of debate.30,31
The primary aim of this study is to evaluate 90-day readmissions and treatment failure of TEVAR compared to OMT as the initial treatment strategy for uaTBAD using the Nationwide Readmissions Database (NRD). The NRD is the first all-payer national database allowing readmission data analysis throughout a calendar year and has successfully been used to study readmission factors for other vascular pathologies.32–36 The hypothesis was that early TEVAR would be associated with lower readmission rates than OMT for uaTBAD.
Methods
Data source
The NRD comprises 57.8% of the U.S. population, encompassing 27 states. This database uses de-identified patient linkage numbers to reliably track patients between hospitals within state lines within a calendar year. Specifically, we queried patients from 2016 to 2018.
Study population
Inclusion criteria were adults diagnosed with aTBAD who underwent either TEVAR or OMT. These criteria were identified using the International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10CM) codes of diagnoses and procedures (Appendix Table 1). Index admission exclusion criteria included chronic, iatrogenic, or traumatic etiologies, open repair, complicated TBAD, and TAAD, and those who died during index hospitalization were excluded from readmissions analysis (Appendix Table 2). Complicated TBAD was defined as aortic rupture or malperfusion signs as per the current Society for Vascular Surgery/Society of Thoracic Surgeons reporting standards for TBAD. 37 Procedural codes of ascending/arch repair, cardioplegia, valve repair, and operations on heart vessels were excluded to differentiate TAAD from TBAD.
Patient/hospital characteristics
Patient and index hospital characteristics were extracted from the NRD for univariate and multivariate analyses. Hospital factors, patient factors, existing comorbidities, and clinical characteristics were assessed.
Statistical analysis
Descriptive analyses were performed for patient demographics, clinical characteristics, and hospital characteristics across treatment groups. Multivariable logistic regression was used for all outcomes, which includes index hospitalization mortality, stroke, SCI, 90-day all cause readmission, and 90-day treatment failure. For readmission outcomes, only Jan–Sep data were used so all patients had at least 3-month follow-up within the calendar year. The primary exposure variable was treatment group (TEVAR vs OMT). All variables tested in descriptive analyses were considered as potential confounders and were included initially. Variables acting as confounders or p < .05 remained in the final model for each outcome. Confounding variables were defined as changing the estimated OR >10%. Generalized estimation equations were applied to account for hospital clustering. Logistic model assumptions were checked using Hosmer–Lemeshow goodness-of-fit test. A p-value <.05 was considered statistically significant. Analysis was performed using SAS, version 9.4 (SAS Institute, Cary, North Carolina, USA).
The primary outcome was 90-day all-cause readmission. Secondary outcomes were 90-day treatment failure (defined as undergoing TEVAR, open aortic repair, or ascending/arch repair on readmission), inpatient mortality, stroke, and SCI.
Results
Patient/hospital baseline characteristics
Patient demographics of index admission cohort separated by treatment type.
Major complications at index admission
Index admission major complications for treatment groups. Frequency represented with n-value and percentages; p-values included.
Associations of TEVAR with index admission outcomes
Index admission mortality. Treatment groups were compared using multivariate logistic regression analysis. Values for odds ratio (OR), confidence interval (CI), and p-value are included. Frequency represented with n-values and percentages. Variables: treatment group, age, gender, income, insurance, APR-DRG disease severity, hospital bed size, hospital area, and major complication.
Index admission stroke. Treatment groups were compared using multivariate logistic regression analysis. OR, CI, and p-value are included. Frequency represented with n-values and percentages. Variables: treatment group, age, and APR-DRG disease severity.
Index admission SCI. Treatment groups were compared using multivariate logistic regression analysis. OR, CI, and p-value are included. Frequency represented with n-values and percentages. Variables: treatment group, gender, insurance, and APR-DRG disease severity.
Associations of TEVAR with 90-day readmission outcomes
90-day all-cause readmission outcomes. Treatment groups were compared using multivariate logistic regression analysis to assess all-cause readmission and readmission for treatment failure. OR, CI, and p-value are included. Frequency represented with n-values and percentages. Variables: treatment group, age, insurance, APR-DRG disease severity, hospital bed size, teaching hospital, major complication, discharge disposition, and index hospital length of stay.
90-day treatment failure. Treatment groups were compared using multivariate logistic regression analysis to assess all-cause readmission and readmission for treatment failure. OR, CI, and p-value are included. Frequency represented as n-values and percentages. Variables: treatment group, age, and insurance.
Discussion
The longstanding standard of care for uaTBAD has been OMT via impulse control. 1 With advancements in endovascular therapy and observed shortcomings in OMT long-term outcomes, the roll for TEVAR in treating uaTBAD remains unclear. This is further supported by the 2017 European Society for Vascular Surgery guidelines for thoracic aortic diseases, stating early TEVAR can be a viable treatment in certain circumstances under careful consideration. 38
The present study reports U.S. nationwide outcomes for uaTBAD patients who received either OMT or early TEVAR. Of the 12,645 patients, 1543 were treated with TEVAR (12.2%). This corroborates the current common practice of not intervening during the acute setting when possible.38–40
Importantly, there were differences observed in demographics between the surgical and medical cohorts. TEVAR patients were more often younger, male, and had fewer comorbidities, suggesting clinicians may be carefully selecting patients who they believe may benefit from early TEVAR. The TEVAR cohort was more often admitted to teaching and larger hospitals, which are more likely to have aortic centers—presumably with more TEVAR experience and better resources.
Interestingly, patients undergoing TEVAR had a lower risk of index admission mortality. This differs from Yi, et al.’s findings, whose retrospective multi-institutional study found no difference in mortality between treatment groups for uaTBAD suggesting clinical equipoise. 31 Perhaps uaTBAD may not be as uncomplicated as its name implies. Progression of dissection while hospitalized may explain OMT’s increased mortality. 41 This study found no difference in 90-day all-cause readmissions or in 90-day readmission for treatment failure between cohorts. Conversely, Yi, et al. found that early TEVAR had lower rates of unplanned readmission (34% vs 9%) and operation (28% vs 8%). 31 Low rates (TEVAR n = 7, OMT n = 64) likely underpowered the analysis in 90-day treatment failure outcomes, causing the discrepancy. Alternatively, the lack of granularity in the NRD or bias introduced by the experience of their involved centers contributed to this difference.
This study has all the limitations of a retrospective review of a large database, including the inability to obtain more granular data, such as anatomical characteristics, medical management adequacy, and aortic remodeling on follow-up imaging. Additionally, the NRD only follows patients through a single calendar year, preventing us from reporting 90-day readmission data beyond 9 months annually. This likely results in an underestimation of readmission and treatment failure rates. Though nationwide, the NRD only tracks patients within each state. Lastly, utilizing a database carries the well-known risk of inaccurate coding, documentation errors, and missing relevant information.
Conclusions
TEVAR and OMT for uaTBAD had no difference in all-cause and treatment failure 90-day readmissions. Early TEVAR was associated with lower index admission mortality, but higher rates of SCI. However, the cohorts differed in demographics and comorbidities; thus, early TEVAR benefits in this study may reflect patient selection bias. These findings provide further evidence to the equipoise of treatment options and support the need for the randomized trials ongoing in the U.S. and Europe investigating outcomes of TEVAR versus OMT for uaTBAD.
Footnotes
Declaration of conflicting interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EO—none; LD—none; JY—none; GM is a consultant for W.L. Gore & Associates and Cook Medical; SH is a consultant for W. L. Gore & Associates, Cook Medical, and Terumo.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Ethical Approval
This study contains data obtained from the Nationwide Readmissions Database (NRD), which contains publicly available de-identified patient information. Based on institutional review board (IRB) criteria, prior IRB approval and patient consent are not required for this study.
Appendix
Inclusion criteria ICD-10 codes. OMT cohort has any of the listed ICD-10 diagnosis codes without the TEVAR procedure code and the TEVAR cohort is with the TEVAR procedure code. Exclusion criteria ICD-10 codes. Open repair, chronic etiology, iatrogenic etiology, traumatic etiology, complicated TBAD defined as ruptured/symptoms of malperfusion, and type A aortic dissection defined as ascending/arch repair and heart surgery.
ICD-10 Code
Description
I71.00
Dissection of unspecified aorta
I71.01
Dissection of thoracic aorta
I71.03
Dissection of thoracoabdominal aorta
02RW4
Thoracic endovascular aortic repair
ICD-10 Code
Description
I71.9
Aortic aneurysm, unruptured
S25.00-02, S25.09
Iatrogenic/traumatic thoracic aortic injury
I71.1
Thoracic aortic aneurysm, ruptured
I71.5
Thoracoabdominal aortic aneurysm, ruptured
N17.0, N17.1, N17.2, N17.8, and N17.9
Acute kidney injury, non-traumatic
K55.059
Acute mesenteric ischemia
M62.2
Acute limb ischemia, non-traumatic
02RW0
Descending thoracic aortic repair, open
02RX
Ascending/arch aortic repair
3E080GC
Cardioplegia
02R5-9, 02RD, 02RF, 02RG, 02RH, 02RJ, 02RK, 02RL, and 02RM
Heart valve repair
0210–0213
Coronary vessel surgery
