Stent Graft Therapy for False Lumen Aneurysmal Degeneration in Established Type B Aortic Dissection (FADED) Results in Differential Volumetric Remodeling of the Thoracic versus Abdominal Aortic Segments

Accepted Manuscript Stent-graft Therapy for False lumen Aneurysmal Degeneration in Established Type B aortic Dissection (FADED) Results in Differential volumetric Remodeling of the thoracic Versus Abdominal aortic Segments Jean Marie Ruddy, Paμl Reisenman, Jennifer Priestley, Luke P. Brewster, Yazan Duwayri, Ravi K. Veeraswamy PII:

S0890-5096(14)00104-6

DOI:

10.1016/j.avsg.2014.02.009

Reference:

AVSG 1948

To appear in:

Annals of Vascular Surgery

Received Date: 10 October 2013 Accepted Date: 5 February 2014

Please cite this article as: Ruddy JM, Reisenman P, Priestley J, Brewster LP, Duwayri Y, Veeraswamy RK, Stent-graft Therapy for False lumen Aneurysmal Degeneration in Established Type B aortic Dissection (FADED) Results in Differential volumetric Remodeling of the thoracic Versus Abdominal aortic Segments, Annals of Vascular Surgery (2014), doi: 10.1016/j.avsg.2014.02.009. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Stent-graft therapy for False lumen Aneurysmal Degeneration in Established type B aortic Dissection (FADED) results in differential volumetric remodeling of the thoracic versus abdominal aortic segments

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Emory University Department of Surgery, Atlanta, GA 30322 Division of Vascular and Endovascular Therapy1 Kennesaw State University, Kennesaw, GA 301442

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Jean Marie Ruddy MD,1 Paul Reisenman MD,1 Jennifer Priestley PhD,2 Luke P. Brewster MD PhD,1 Yazan Duwayri MD,1 and Ravi K. Veeraswamy MD1

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Corresponding Author Ravi Veeraswamy, MD Emory University Department of Surgery Division of Vascular and Endovascular Therapy 1365 Clifton Road, NE 3rd Floor Atlanta, GA 30322

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Abstract Objective: Despite optimal medical therapy of type B aortic dissections, false lumen aneurysmal degeneration of these established dissections (FADED) occur over the

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long-term (>6 months). The efficacy of thoracic stent-grafts (TEVAR) in promoting aortic remodeling when placed at late time points remains controversial and was

the focus of this investigation. Methods: Utilizing tomographic scans, the volume of

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six distinct aortic compartments were calculated including the stented true and false lumens (STL & SFL), below stent true and false lumens (BSTL & BSFL), and the infra-

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renal aorta true and false lumens (IRA TL & FL) when applicable. Cross-sectional areas were calculated at one centimeter intervals, collated, and volumetric ratios were derived from pre-operative values. Results: From 2004-2011, twenty-one patients met inclusion criteria. Complete false lumen thrombosis was achieved in

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85.7% of SFL and 26.3% BSFL. Volumetric analysis demonstrated that 71% of patients had increased STL volume and 71% had decreased SFL. In the BS region, 75% of patients had increased TL with 59% concurrently decreased FL volume. The

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IRA TL volume increased in 85% of patients and the IRA FL also expanded in 75% of

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this cohort. At the latest time point, overall growth was noted in the infra-renal aortic segment. Conclusions: Utilization of TEVAR in patients suffering from FADED can promote true lumen expansion with concurrent false lumen regression, however progressive dilation in the total infra-renal aorta volume may occur and warrants close surveillance.

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Introduction Stanford type B aortic dissection (TBAD) is a potentially lethal pathology for which treatment algorithms continue to evolve. Thoracic stent-graft placement

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(TEVAR) has gained acceptance in patients presenting acutely with malperfusion,

rupture, impending rupture, or uncontrolled pain, while aggressive blood pressure and heart rate control with anti-impulse therapy has proven effective in

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uncomplicated cases and continues to be the accepted treatment modality.1-3 Even when successful, however, five-year survival only ranges from 60-80%, largely due

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to the progressive aneurysmal degeneration observed during this chronic phase.4 False lumen Aneurysmal Degeneration in Established Dissection, hereafter designated FADED, is therefore a significant contributor to late mortality in TBAD by increasing the risk of life-threatening events such as aortic rupture and dissection

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extension.5,6 Thrombosis of the false lumen may be protective against late complications but only occurs in 19% of medically managed patients.7 The INSTEAD trial showed improved false lumen thrombosis when TEVAR was used in

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uncomplicated chronic dissections (up to 91%), defining “chronic” as a dissection

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that has had atleast 14 days of effective medical therapy.7,8 However, this distinction may allow a heterogeneous group of patients to be incorporated in a study of TEVAR for uncomplicated dissection and obscure aortic remodeling trends.9 Aneurysmal degeneration following TBAD, however, will take several months to develop and is expected to be accompanied by intimal flap fibrosis, implicating that these patients may respond uniquely to TEVAR.10 Successful coverage of the proximal entry tear and reductive remodeling of the false lumen along with concomitant true lumen

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expansion following TEVAR for chronic TBAD have been reported by several institutional reviews11,12 but detailed data sets of the fate of the thoracic and abdominal aortic segments remain limited, especially in those with aneurysmal

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degeneration. We performed a single center retrospective study to address whether TEVAR is effective in inducing aortic remodeling in patients with FADED. We limited our study to patients who had a TBAD for at least 6 months and studied volumetric

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changes in the stented, below stent, and infra-renal aorta regions to further

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characterize the effect of TEVAR on the entire dissected aorta.

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Methods Retrospective review of the Emory University Vascular Surgery Database was conducted from 2004-2011 to identify patients who underwent TEVAR for

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chronic TBAD with FADED. Interventions were offered to those with thoracic aortic diameter >5.5cm or rapid aortic expansion. Patients treated with TEVAR less than 6 months from dissection event and those without comparative pre-operative and

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post-operative imaging were excluded. Patient demographics were collected as well as additional procedure related details including date of dissection diagnosis, date of

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procedure, maximal aortic diameter, treatment length, adjunctive procedures, and dates of pre-operative and post-operative cross-sectional imaging. Computed tomographic (CT) scans were analyzed with TeraRecon software (TeraRecon, Inc, Foster City, CA) where the cross-sectional area of each aortic compartment was

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traced manually at one centimeter intervals from the left subclavian artery to the aortic bifurcation and collated to generate volumetric data. Aortic compartments included the stented true lumen (STL) and “peri-stented” false lumen (SFL) in the

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thoracic aorta. The below stent true and false lumens (BSTL and BSFL, respectively)

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were defined from the inferior edge of the stent to the celiac axis. The infra-renal aorta true and false lumens (IRA TL and IRA FL, respectively) were also measured. Total aortic volumes were also generated in the stented, below stent, and infra-renal segments, and the state of false lumen thrombosis (complete, partial, or patent) was documented on each follow-up scan within the SFL and BSFL. Volumetric data post-TEVAR was normalized to the corresponding preoperative values and reported as a percent change from baseline. All volume data

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points collected during the first year of follow-up were evaluated to determine the proportion of patients experiencing an increase or decrease in volume. The average volumetric change for each compartment was also calculated at each time point.

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Review Board of Emory University approved this study.

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Given the small sample size, statistical analysis was not conducted. The Institutional

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Results Over the eight years included in this retrospective review, 55 TEVAR were performed for FADED at Emory University Hospital and 21 of those patients met the

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inclusion criteria of undergoing at least 6 months of medical therapy prior to TEVAR and had adequate imaging. The demographics of this group have been summarized in Table 1. Notably, the majority of these patients were male and hypertensive. The

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left subclavian artery was covered in 71.4% of cases with approximately 25% of this cohort undergoing concomitant ipsilateral carotid-subclavian bypass (19% of the

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total group, Table 2). Therapeutic goal of covering the primary entry tear was achieved in 100% of patients, treatment length averaged 183.3mm, and the majority of patients had a single device implanted. Alternatively, three patients required 3 stents and one patient required 2 stents (Table 2). Peri-operative lumbar drainage

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was utilized selectively at the discretion of the operating surgeon (19%), no spinal cord ischemic events were noted in the entire cohort, and at conclusion of the study a 33% mortality rate was noted (Table 2).

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The length of dissection varied among the patient cohort but 80% had false lumen extension to the celiac axis and beyond (Table 3). Pictorial representation of

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the six aortic compartments analyzed in this study is demonstrated in Figure 1. Complete SFL thrombosis was achieved in 85.6% of patients and complete thrombosis of BSFL was seen in 26.3%, with partial thrombosis in 57.9% (Table 3). Of the 21 patients, 15 experienced an increase in STL volume after TEVAR,

averaging 60% over baseline while 6 patients had an average of 11% decrease of STL (Figure 2). In addition to tracking individual patient responses to TEVAR treatment, average volumetric changes were calculated over one year of follow up to

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approximate aortic remodeling trends. Overall, an increase in STL over one year can be seen in Figure 3. Fifteen patients demonstrated a 33% decrease in the SFL volume while the SFL volume increased in 6 patients by an average of 11% (Figure

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2). In the entire cohort, an average decrease in SFL over one year can be seen in Figure 3. The total aortic volume in the stented region increased in 13 patients

following TEVAR, averaging 14%, while the remaining 8 patients experienced a 23%

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decrease (Figure 2). An overall decrease in stented total aortic volume at one year can be seen in Figure 3.

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Twenty patients had BSTL measurements, 15 had increased volumes after TEVAR with mean of 43%, and the remaining 5 patients demonstrated 6% decreased BSTL volume (Figure 4). The average increase in BSTL over one year can be seen in Figure 5. When considering the BSFL measurements, two patients were

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eliminated because the false lumen did not extend below the stent and one patient was excluded from the analysis because the volume remained stable from pre-op (value of 1). Of the remaining 17 patients, 7 had an increased BSFL, averaging 18%,

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and approximately 13% decreased volume was noted in the remainder (Figure 4).

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Overall, a decrease in BSFL over one year was recorded, as seen in Figure 5. The BS total aorta measurements included 12 patients with increased volume of 16% and 8 patients with 11% decrease (Figure 4). The BS total aortic volume over one year decreased (Figure 5).

Thirteen patients had data collected in the IRA. Increased IRA TL was documented in 11 patients, averaging 67%, and the other 2 had 10% decrease after TEVAR (Figure 6). A modest increase in IRA TL over one year was observed (Figure

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7). Similar to the below stent region, one patient was eliminated from the IRA FL analysis based on dissection anatomy. A 14% increase in IRA FL was recorded in 9 patients, while the other 3 patients demonstrated 7% decrease (Figure 6).

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Volumetric measurements of IRA FL over one year remained essentially stable (Figure 7). The IRA total aorta volume increased in 10 patients by 16% and

decreased in the remaining 3 by 6% (Figure 6). The IRA total aortic volume was

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increased over one year (Figure 7).

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Discussion Current medical management of acute uncomplicated TBAD may contribute to an increased prevalence of patients with False lumen Aneurysmal Degeneration

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of an Established Dissection (FADED) over the long term (>6 months), therefore the selection of safe and effective surgical interventions has become the focus of several retrospective and prospective data analyses. True and false lumen volumetric

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remodeling of three specific aortic segments in 21 FADED patients treated with

TEVAR at a single institution have been reported, with the majority demonstrating

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thoracic true lumen expansion with concurrent false lumen regression. When the total aortic volume of each segment was analyzed, however, the thoracic segments (stented and below-stent) had contracted at one year while the infra-renal abdominal aortic segment had mild dilation. This differential remodeling may be

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influenced by several factors such as intrinsic aortic wall parameters and pressure within the patent false lumen.

False lumen thrombosis is a vital component of aortic remodeling in TBAD,

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with several single institution studies tracking this parameter by aortic diameter,

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cross-sectional area, or lumen volumes.13-17 Pre-emptive placement of TEVAR in those with stable chronic TBAD has recently demonstrated long term aorta-related survival benefit in conjunction with a 90% rate of thoracic false lumen thrombosis.18 In patients with FADED, additional considerations regarding fibrotic flap immobility and persistent retrograde perfusion through distal fenestrations has raised additional concerns about the long-term efficacy of TEVAR. Interestingly, when pressure sensors were implanted in the thoracic false lumen of those undergoing

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TEVAR for aneurysmal degeneration of a chronic dissection, sac pressure recordings were half that of the true lumen immediately after implantation and decreased to 14% over long-term follow-up with concurrent false lumen thrombosis,19 but the

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extrapolation of this pressure reduction to the IRA has yet to be confirmed. Focus

has, however, shifted to the extent of false lumen thrombosis. A review of medically managed patients with partial false lumen thrombosis demonstrated increased

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rupture risk, but application of that data to patients whose proximal tear has been occluded with TEVAR may be erroneous.15 It is clear that increased treatment

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lengths lead to increased thoracic false lumen thrombosis, but routinely extending stent-grafts to eliminate retrograde flow may have significant implications for spinal cord perfusion.16,20,21 The question remains, therefore, as to how much of the false lumen must thrombose to initiate reductive remodeling and protect the patient

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from further aortic expansion with eventual rupture. The data presented from this group of patients with FADED are consistent with other single-institution reports demonstrating successful coverage of primary

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entry tear and reductive false lumen remodeling, but by uniquely utilizing hand-held

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volumetric analysis, the cohort’s segmental aortic response to TEVAR was tracked. Additionally, individual patient response to TEVAR was considered rather than only focusing on the average volumetric change from baseline. Favorable true and false lumen remodeling was identified in the thoracic aorta of the majority of patients, despite the fact that the below-stent region extending to the celiac axis was frequently only partially thrombosed, suggesting that neither flap fibrosis nor continuous retrograde perfusion impeded thoracic aortic remodeling after TEVAR.

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The infra-renal aortic segment, however, remodeled differently and false lumen expansion was recorded in 75% of patients along with mild total aorta volume increase in the infra-renal segment at one year. This differential remodeling trend

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has been observed by other investigators treating TBAD with TEVAR.12,22

Morphologic examination of stent-graft utilization for proximal entry tear coverage followed by bare metal stent extension into the abdominal aortic segment have also

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identified alternative trends of thoracic versus abdominal aortic remodeling.23,24 This study has several limitations related to its retrospective nature at a

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single institution. The inclusion criteria were deliberately strict to improve homogeneity within the series but consequently led to small sample size that precluded meaningful statistical analysis. Consistent follow-up imaging was also difficult to obtain at this tertiary referral center where patients frequently travel

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several hours for therapy but request follow up imaging to be conducted locally or fail to return as scheduled. Similar trends of poor compliance have recently been reported following endovascular aortic interventions with 11% of patients never

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returning and 56% becoming lost to follow up over three years.25 Structured

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protocols to improve clinic visit attendance and image collection from referring physicians is currently being considered. Moreover, this study only reports aortic remodeling over one year post-TEVAR, significantly limiting its predictive implications but providing an effective snapshot of aortic reaction to stent-graft therapy. Future directives for improved long-term follow-up may allow identification and analysis of additional remodeling outcomes.

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Conclusions False lumen aneurysmal degeneration of an established dissection (FADED)

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occurs in at least one-third of patients undergoing long-term medical management. This report supports TEVAR therapy with overall expansion of the aortic true lumen and regression of the thoracic false lumen. Targeted examination of the below-stent

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thoracic region demonstrated favorable remodeling despite only partial false lumen thrombosis. Increased infra-renal aortic volume was also observed, however, and

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warrants continued surveillance imaging.

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Kim KM, Donayre CE, Reynolds TS, et al. Aortic remodeling, volumetric analysis, and clinical outcomes of endoluminal exclusion of acute complicated type B thoracic aortic dissections. Journal of vascular surgery. Aug 2011;54(2):316-324; discussion 324-315. Schoder M, Czerny M, Cejna M, et al. Endovascular repair of acute type B aortic dissection: long-term follow-up of true and false lumen diameter changes. The Annals of thoracic surgery. Mar 2007;83(3):1059-1066. Bernard Y, Zimmermann H, Chocron S, et al. False lumen patency as a predictor of late outcome in aortic dissection. The American journal of cardiology. Jun 15 2001;87(12):1378-1382. Stanley GA, Murphy EH, Knowles M, et al. Volumetric analysis of type B aortic dissections treated with thoracic endovascular aortic repair. Journal of vascular surgery. Oct 2011;54(4):985-992; discussion 992. Conrad MF, Crawford RS, Kwolek CJ, Brewster DC, Brady TJ, Cambria RP. Aortic remodeling after endovascular repair of acute complicated type B aortic dissection. Journal of vascular surgery. Sep 2009;50(3):510-517. Nienaber CA, Kische S, Rousseau H, et al. Endovascular repair of type B aortic dissection: long-term results of the randomized investigation of stent grafts in aortic dissection trial. Circulation. Cardiovascular interventions. Aug 2013;6(4):407-416. Parsa CJ, Williams JB, Bhattacharya SD, et al. Midterm results with thoracic endovascular aortic repair for chronic type B aortic dissection with associated aneurysm. The Journal of thoracic and cardiovascular surgery. Feb 2011;141(2):322-327. Czerny M, Roedler S, Fakhimi S, et al. Midterm results of thoracic endovascular aortic repair in patients with aneurysms involving the descending aorta originating from chronic type B dissections. The Annals of thoracic surgery. Jul 2010;90(1):90-94. Buth J, Harris PL, Hobo R, et al. Neurologic complications associated with endovascular repair of thoracic aortic pathology: Incidence and risk factors. a study from the European Collaborators on Stent/Graft Techniques for Aortic Aneurysm Repair (EUROSTAR) registry. Journal of vascular surgery. Dec 2007;46(6):1103-1110; discussion 1110-1101. Leshnower BG, Szeto WY, Pochettino A, et al. Thoracic endografting reduces morbidity and remodels the thoracic aorta in DeBakey III aneurysms. The Annals of thoracic surgery. Mar 2013;95(3):914-921. Lombardi JV, Cambria RP, Nienaber CA, et al. Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design. Journal of vascular surgery. Mar 2012;55(3):629-640 e622. Melissano G, Bertoglio L, Rinaldi E, et al. Volume changes in aortic true and false lumen after the "PETTICOAT" procedure for type B aortic dissection. Journal of vascular surgery. Mar 2012;55(3):641-651. Kret MR, Azarbal AF, Mitchell EL, Liem TK, Landry GJ, Moneta GL. Compliance with long-term surveillance recommendations following endovascular

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aneurysm repair or type B aortic dissection. Journal of vascular surgery. Feb 25 2013.

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Figure 1. Pictoral representation of the six aortic compartments measured in each pre-operative and post-operative scan. Figure 2. Number of patients experiencing volumetric change in the stented true

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lumen (STL), stented false lumen (SFL), and total stented regions.

Figure 3. Ratio of volumetric change in the stented true lumen (STL), stented false lumen (SFL), and total stented regions over one year of follow up.

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Figure 4. Number of patients experiencing volumetric change in the below stent true lumen (BSTL), below stent false lumen (BSFL), and total below stent regions.

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Figure 5. Ratio of volumetric change in the below stent true lumen (BSTL), below stent false lumen (BSFL), and total below stent regions over one year of follow up. Figure 6. Number of patients experiencing volumetric change in the infra-renal

renal aorta regions.

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aorta true lumen (IRA TL), infra-renal aorta false lumen (IRA FL), and total infra-

Figure 7. Ratio of volumetric change in the infra-renal aorta true lumen (IRA TL),

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year of follow up.

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infra-renal aorta false lumen (IRA FL), and total infra-renal aorta regions over one

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Table 1. Demographic data on 21 FADED patients treated with TEVAR. Age (yrs)

Gender

DM

HTN

CRI

Diameter (mm)

1

66.7

M

N

Y

Y

46.8

2

46

M

N

Y

N

59.2

3

62.5

M

N

Y

N

4

58.4

F

N

Y

Y

5

82.8

F

N

Y

N

6

75.2

M

N

Y

N

63.2

7

47

M

N

Y

N

53.3

8

60

M

9

69.7

M

10

50.2

M

11

75

M

12

62.5

F

13

63.2

14

50.3

15

52.5

50.4

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61.6

Y

N

55.2

N

Y

N

62.6

N

Y

N

61

Y

Y

N

51.4

N

Y

N

70

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N

Y

Y

N

51.6

M

N

Y

N

50

F

N

Y

N

62.3

51.6

M

N

Y

N

71.5

63.5

M

N

Y

N

71.6

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17

67.8

F

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16

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FADED pt #

18

66.4

M

Y

Y

N

56.9

19

53.2

M

N

Y

N

74.5

20

62.1

M

N

Y

N

74.7

21

70

M

N

Y

N

75.1

61.4

76% M

14.3%

100%

9.5%

61.5

Abbreviations: False lumen Aneurysmal Degeneration of Established Dissection (FADED); Diabetes mellitus (DM); Hypertension (HTN); Chronic renal insufficiency (CRI)

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Device length (mm) (# stents)

SCA coverage

CCA to SCA bypass

Lumbar drain

SCI

Mortality

1

115 (3)

N

N

Y

N

Y

2

150

Y

N

N

3

199

Y

N

N

4

200

Y

N

N

5

244 (3)

Y

N

N

6

200

Y

N

N

7

150

Y

N

N

8

150

Y

N

9

200

Y

10

200

Y

11

200

N

12

202

13

200

14

150

15

150

16 17

19 20 21

N

N

Y

N

N

N

N

N

Y

N

N

N

N

N

Y

N

N

N

N

N

N

Y

N

N

N

Y

Y

Y

N

N

N

N

N

N

N

Y

Y

Y

N

N

N

Y

N

N

N

N

180 (2)

Y

N

N

N

Y

150

N

N

N

N

N

157

N

N

N

N

N

200

Y

Y

Y

N

N

152

N

N

Y

N

N

300 (3)

Y

N

Y

N

N

183.3

71.4%

19%

19%

0%

33.3%

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N

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18

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FADED pt #

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Table 2. Procedure-related data on 21 FADED patients treated with TEVAR.

Abbreviations: Subclavian artery (SCA); Common carotid artery (CCA); Spinal cord ischemia (SCI)

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Table 3. Post-TEVAR extent of false lumen thrombosis (FLT) in 21 FADED patients. FADED Dissection pt # extension

Pre-op Thoracic FLT

Post-TEVAR Stented FLT

Post-TEVAR Below-stent FLT

Iliacs

patent

Complete

partial

2

Iliacs

patent

Complete

complete

3

Iliacs

patent

Partial

4

Iliacs

partial

Complete

5

DTA

partial

complete

6

Renals

patent

complete

7

Iliacs

patent

complete

8

Iliacs

patent

9

Iliacs

patent

10

Iliacs

partial

11

SMA

patent

12

Renals

patent

13

Celiac

14

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1

patent

partial

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N/A

partial complete partial

complete

partial

complete

complete

complete

partial

complete

partial

patent

complete

partial

Iliacs

patent

complete

complete

15

Iliacs

partial

complete

partial

16

DTA

patent

partial

patent

17

Renals

patent

complete

partial

Iliacs

patent

complete

partial

Iliacs

partial

complete

complete

Renals

partial

partial

patent

DTA

partial

complete

N/A

80% beyond Celiac

33.3% partial FLT

85.7% complete FLT

26.3% complete; 57.9% partial FLT

19 20 21

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18

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complete

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TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT