Endovascular and Open Repair of Ruptured Infrarenal Aortic Aneurysms at a Tertiary Care Center

Accepted Manuscript Endovascular and Open Repair of Ruptured Infrarenal Aortic Aneurysms at a Tertiary Care Center Matthew A. Schechter, M.D., Luigi Pascarella, M.D., Steven Thomas, Ph.D., Richard L. McCann, M.D., Leila Mureebe, M.D. , M.P.H. PII:

S0890-5096(17)30283-2

DOI:

10.1016/j.avsg.2016.10.037

Reference:

AVSG 3165

To appear in:

Annals of Vascular Surgery

Received Date: 23 May 2016 Revised Date:

2 October 2016

Accepted Date: 3 October 2016

Please cite this article as: Schechter MA, Pascarella L, Thomas S, McCann RL, Mureebe L, Endovascular and Open Repair of Ruptured Infrarenal Aortic Aneurysms at a Tertiary Care Center, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2016.10.037. 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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Endovascular and Open Repair of Ruptured Infrarenal Aortic Aneurysms at a Tertiary Care

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Center

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Matthew A. Schechter, M.D., Luigi Pascarella, M.D., Steven Thomas, Ph.D., Richard L. McCann,

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M.D. , Leila Mureebe, M.D. , M.P.H.

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Department of Surgery, Duke University Medical Center Durham, North Carolina

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Running Title: Endovascular and open repair of ruptured AAA

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Key words: Abdominal aorta; endovascular repair; open repair; outcomes

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10 Address correspondence to:

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Leila Mureebe, MD, MPH

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Department of Surgery, Division of Vascular Surgery

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DUMC, Box 3467

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Durham, NC 27710

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Phone: (919) 681-2550

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E-mail: [email protected]

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ABSTRACT

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Objective: The mortality of ruptured infrarenal abdominal aortic aneurysms (rAAA) has been

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reported as high as 90%. Loss of consciousness and a systolic blood pressure of < 80mmHg on

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presentation are the most important predictors of mortality after emergent open repair (OR).

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Endovascular repair of abdominal aortic aneurysm (EVAR) has reduced short-term operative

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mortality and morbidity for elective abdominal aortic aneurysm repair, and many be advocated

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for wider application of EVAR for rAAA. The objective of this study is to compare our experience

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with OR and EVAR management of rAAA.

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Methods: Retrospective review of all rAAA presenting to a tertiary care center between January

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1, 2000 and December 31, 2011 was performed. Patients were grouped based on the surgical

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approach (OR versus EVAR). Patient demographics, intra-operative details, and post-operative

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mortality and morbidity rates were compared. Statistical analyses were conducted with Stata,

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version 12.

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Results: One hundred twenty-six patients presented with rAAA over the study period. Patients

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who declined repair (n = 14), or died prior to repair (n = 13) were excluded from this study. Of

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the 99 patients who underwent repair, 25 patients (25.3%) received EVAR and 74 (74.7%)

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underwent OR. One patient required conversion to OR from EVAR (1.0%). Overall 30-day and 1-

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year mortality were 35.4% and 41.4%, respectively, with no difference seen between the two

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types of repair (30-day: EVAR = 24.0%, OR = 39.2%, p = 0.17; 1-year: EVAR = 32.0%, OR = 44.6%,

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p = 0.27). Major morbidity also did not differ between the two repair procedures (EVAR =

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60.0%, OR = 60.8%, p = 0.94) However, patients undergoing EVAR had significantly less

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estimated blood loss (median: 0.3 versus 3.0 L, p < 0.0001) and transfusion requirement

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(median: 5.0 versus 9.0 units, p = 0.0041). Furthermore, although there was no significant

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difference in length of overall hospital length of stay between the two groups (8.5 versus 15

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days in OR group, p = 0.18), significantly more patients in the EVAR group were discharged to

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home (66.7% versus 57.1% in OR group, p = 0.03)

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Conclusions: In contrast to recently published series, this series shows no differences in

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morbidity or mortality between endovascular or open repair of ruptured AAAs. EVAR is

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appropriate in stable patients with a rAAA and favorable anatomy.

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TEXT [2177 Words]

47 1. INTRODUCTION

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Ruptured abdominal aortic aneurysms (rAAA) remain a vascular emergency, with a mortality

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rate of 80-90%.[1] For patients who undergo conventional open repair (OR), the mortality rate

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has consistently remained around 50%.[2-4] The poor outcomes of OR, combined with the

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reduced peri-operative morbidity and mortality of endovascular aneurysm repair (EVAR)

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observed in the elective setting, has led to increasing interest in using this technology for rAAA.

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EVAR for rAAA has been slowly increasing in frequency, with as an estimated 18.9% of rAAA

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repaired via EVAR in 2006.[5] However, the use of EVAR in preference to OR for rAAA remains

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controversial. Several retrospective series have shown outcomes following EVAR for rAAA to be

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better than OR,[6-9] and analyses of national databases seem to suggest reduced morbidity and

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mortality with EVAR.[10-13] However, multiple randomized controlled trials failed to show an

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improvement in either survival or severe complications with EVAR versus OR for rAAA.[14-16]

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Given the continued debate regarding the management of rAAA, this aim of this study was to

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compare EVAR to open repair of rAAA at high-volume, university-based tertiary care aortic

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center.

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2. METHODS

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The Institutional Review Board of Duke University Medical Center approved this study, and the

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need for patient consent was waived. A retrospective review was performed to identify all

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patients who presented to Duke University Medical Center with a ruptured or symptomatic

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infrarenal aortic aneurysm between January 2000 and September 2011. Ruptured abdominal

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aortic aneurysm was defined as the presence of extraluminal blood on an abdominal computed

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tomography or at a laparatomy. Patient demographics, including comorbidities, systolic blood

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pressure, creatinine and estimated glomerular filtration rate at presentation were collected for

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all patients. Systolic blood pressure upon admission to the Emergency Department was

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considered as a surrogate of hemodynamic stability, and a systolic blood pressure (SBP) less

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than 80 mmHg was considered hemodynamically unstable.

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The selection of treatment was made by the attending vascular surgeon based upon whether

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aortic anatomy was amenable to EVAR. Procedural data, including cardiac arrest during the

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procedure, use of an aortic occlusion device prior to definitive intervention, location of clamp

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(in OR), estimated blood loss (EBL), units of packed red blood cell (PRBC) transfused, volume of

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IV fluid administered, length of procedure, and whether the patient’s abdomen was left open

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was collected from the operative report and anesthesia records.

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The primary outcome measure was overall survival. 30-day in-hospital mortality was also

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calculated. Secondary outcomes were 30-day major morbidity, reintervention rate, length of

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ICU stay, overall length of post-operative hospital stay, and discharge status. Major morbidity

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included respiratory failure, abdominal compartment syndrome, acute renal failure, atrial

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fibrillation, myocardial infarction, wound dehiscence, postoperative bleeding, intestinal

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ischemia, deep vein thrombosis (DVT), failure to thrive, lower extremity ischemia, and

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pneumonia. Acute renal failure was defined as need for new-onset renal replacement therapy,

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while respiratory failure was defined as need for tracheostomy. The remaining complications

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were defined according to standard guidelines.[17] Decompressive laparotomies done at the

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time of endovascular repair were not counted as reinterventions, but those patients were

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counted as having developed abdominal compartment syndrome. For length-of-stay

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calculations, patients who died within 24 hours of repair (LOS = 0) were excluded.

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Continuous variables were checked for normality using Kolmogorov-Smirnov tests and are

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presented as mean with the standard deviation (SD). Categorical variables are presented as

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percentages. Comparisons between OR and EVAR were conducted using either Student’s t-test

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or Mann-Whitney U-test depending on distribution. Association between outcomes and

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categorical variables (race, gender, dichotomized comorbidities) will be examined using chi-

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squared tests. Statistical significance is defined as p < .05. Long-term survival will be assessed

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using Kaplan-Meier survival analysis with a log-rank test.

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3. RESULTS

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From January 2000 to December 2011, 126 patients were transferred to Duke University

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Medical Center with a diagnosis of ruptured infrarenal aortic aneurysm. Fourteen patients

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refused repair, while two patients were already in cardiac arrest upon arrival to the hospital,

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three patients arrested either in emergency department or on way to OR, and eight patients

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died upon cross-clamp/occlusion of the aorta. These patients were not included in the analysis.

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The demographic and preoperative data, including comorbidities, of the 99 patients who

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underwent repair are shown in Table 1. Patients were predominantly male (N = 89, 89.9%).

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Median systolic blood pressure at presentation was 120 mmHg (range: 50 - 220 mmHg), with 10

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patients (11.9%) presenting with signs of hemodynamic instability (SBP < 80 mmHg).

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Within the cohort, twenty-five (25.2%) received an EVAR, with the remaining 74 patients

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undergoing OR. The majority of EVARs (18/25, 72.0 %) were performed between 2006 and

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2011. Of the patients undergoing OR, 27 (36.5%) required a suprarenal aortic cross-clamp. The

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intraoperative data are summarized in table 2. The procedure lengths were not statistically

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different between the two groups (median: EVAR = 172 minutes, OR = 194 minutes, p = 0.35).

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Aortic occlusion balloons were used in four (16%) EVAR cases and five (6.5%) of open cases (p =

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0.22). Operative blood loss was significantly lower for patients who underwent EVAR (median:

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300 vs. 3000 mL for OR, p < 0.0001), and these patients also received less blood products

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(median: 5 vs. 9 units for OR, p = 0.004) and total IV fluid resuscitation (median: 7.5 vs. 10.2 L in

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OR, p = 0.0061). However, the percentage of patients who left the operating room with open

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abdomens was not significantly different between the two groups (EVAR = 20%, OR = 12.2%, p =

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0.55)

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For all patients undergoing rAAA repair, the 30-day mortality was 35.4% (35/99) and the overall

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complication rate was 60.6% (60/99). Ten patients (10.1%) died within the first 24 hours post-

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operatively, with nine of those patients having undergone OR. The perioperative outcomes are

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outlined in table 3. Neither post-operative morbidity nor 30-day mortality was statistically

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different between the two repair modalities (Mortality: EVAR = 24.0%, OR: 39.2%, p = 0.17;

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complication rate: EVAR = 64.0%, OR = 60.8%, p = 0.82). When comparing only OR patients who

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had an infrarenal aortic cross-clamp (n = 47) to the EVAR group, the 30-day mortality is nearly

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the same (Infrarenal OR = 25.5%, EVAR = 24.0%, p = 0.89)

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Respiratory failure (25.3%) and acute renal insufficiency (21.1%) were the most frequent

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complications after rAAA repair, and did not significantly differ between the two groups. Six

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patients in the OR group (8.1%) developed intestinal ischemia, with three requiring resection,

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while three EVAR patients (12.0%) also developed this condition, but none required surgical

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intervention. However, the overall reintervention rate in the EVAR group was significantly

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higher than in the OR group (20.0% versus 2.7%, respectively; p = 0.004). Two patients within

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the EVAR group required a decompressive laparotomy for abdominal compartment syndrome,

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with one patient undergoing colonic resection as well, while two patients had delayed

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presentation of a type 1a endoleak that required repair. The final EVAR patient developed

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ureteral obstruction, requiring cystoscopy and stent placement.

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The endoleak rate within the EVAR cohort was 24.0% (6 patients). Three of these patients had

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type 2 endoleaks, which were followed non-operatively and had subsided within 1-month per

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CT scan. The remaining 3 patients developed type 1a endoleaks in the post-operative period.

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Two of the patients required a proximal aortic cuff, requiring coverage of the renal arteries for

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one patient. The third patient died shortly after diagnosis before any intervention could be

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attempted.

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Mean length of ICU stay and overall hospital stay for the entire cohort was 5 and 11 days,

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respectively (Table 3). Neither the length of ICU stay nor the total post-operative hospital stay

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was significantly different between the two groups (Median ICU stay (IQR): EVAR = 3 days

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(1.5,15), OR = 5 (2,13), p = 0.38; median total stay (IQR): EVAR = 8.5 (4,21.5); OR = 15 days

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(8,23), p = 0.18). However, the percentage of patients able to be discharged to home, which is

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considered a basic measure of return of functional status, was statistically different (EVAR:

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66.7%, OR: 57.1%; p = 0.03). The 1-year mortality for the entire cohort was 41.4% (41/99), and

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was not significantly different between the two treatment modalities (EVAR = 32.0%, OR =

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44.6%, p = 0.27).

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4. DISCUSSION

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Since its first reported use by Yusuf, et al. in 1994[18], EVAR of rAAA has increased in

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popularity, to the point that some high volume centers have proposed an “endovascular-first”

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approach to this highly morbid condition. [9, 19-23] However, the literature remains conflicted

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regarding the benefit of such an algorithm on outcomes. In this study, we demonstrate no

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survival advantage to endovascular repair of ruptured abdominal aortic aneurysms over

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conventional open repair. There was also no difference in the development of post-operative

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complications or ability to return to home upon discharge between the two repair techniques.

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Our study is congruent with the findings of the few randomized controlled trials examining this

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topic. The first was a small, single-center trial involving 32 patients, which showed a 30-day

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mortality of 53% in both the EVAR and OR groups.[14] The Amsterdam Acute Aneurysm Trial

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(AJAX) randomized 116 patients with rAAA in 10 participating hospitals to either OR or EVAR

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between April 2004 and February 2011. The 30-day/in-hospital mortality was not different

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between the two repair strategies (EVAR = 28%, OR = 29%; p = 1.00), nor was the incidence of

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major complications (EVAR = 32%, OR = 37%; p = 0.56).[15] However, the estimated blood loss

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and transfusion requirement were significantly reduced in the EVAR group, consistent with our

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study.15 The largest randomized trial, the Immediate Management of the patient with Rupture:

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Open vs Endovascular Repair (IMPROVE) trial, involved 613 patients with rAAA across 30

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different medical centers. As with the prior two randomized trials, and this current study, there

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was no difference in 30-day mortality between open and endovascular repair (37.4% versus

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35.4%, respectively; p = 0.62).[16] More recently, the Ruptured Aneurysm Trialists released a

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meta-analysis of three trials looking at endovascular versus open repair, and the pooled results

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showed a slightly lower 1-year mortality after EVAR, but this was not statistically significant

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(p=0.24).[24]

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Although none of these studies, including ours, found a significant survival benefit to

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endovascular repair, there is evidence that EVAR may provide other benefits beyond survival. In

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the IMPROVE trial, as with this current study, more patients returned home (versus a nursing or

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rehab facility) in the EVAR group compared to the open group.[25] In addition to the benefits in

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terms of a quicker return to basic functional status and normal quality of life, a higher rate of

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discharge to home also decreases total healthcare utilization, improving the overall cost-

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effectiveness of the endovascular repair.[25]

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Common to these randomized trials, as well as the current study, is the relatively low mortality

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associated with open repair. Multiple studies, including those that suggest a survival advantage

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to EVAR, report mortality rates of open repair to be at or above 50%.[19, 26, 27] Such high

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mortality rates of OR are in part due to unfavorable hemodynamic and anatomic characteristics

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upon presentation that have in the past excluded attempts at endovascular repair. However,

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center experience with rAAA and other aortic conditions also seems to play an important role in

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improving survival. As Holt, et al. noted in their study comparing EVAR to OR for rAAA, “repair

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of rAAA at hospitals with a higher elective aneurysm workload was associated with lower

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mortality rates irrespective of the mode of treatment.”[28] Indeed, such a finding has been

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confirmed in multiple other studies.[5, 29, 30]

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Given the overall improved survival in patients treated at high-volume tertiary centers, the

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discussion regarding the treatment of rAAA may not be one of technique, but of

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regionalization. Such regionalization has already been observed with elective AAA repair, and is

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associated with a concurrent decrease in patient mortality.[31] These high-volume centers not

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only have the multidisciplinary infrastructure to determine and execute the best operative

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strategy, but also the ability to better recognize and address the post-operative complications

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that also affect survival. Thus, the decrease in patient mortality seen with the introduction of

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“endovascular-first” protocols[20, 22, 32] may not be solely due to the benefit of EVAR, but

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could also be explained by the overall streamlining of these patients’ care. As noted in the AJAX

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trial, in addition to the use of EVAR for the treatment of their rAAA, they also introduced

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“round-the-clock acute aneurysm service in the greater Amsterdam region, centralization of

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aneurysm care, and the routine preoperative CTA,” the latter of which led to a dramatic

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decrease in overall mortality within the rAAA population (30% from the national average of

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41%).[15] As with the AJAX trial, our study not only found no survival difference between the

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two operative strategies, but also a lower overall 30-day mortality (32.2%) than the national

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average (~40%).

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This study is not without limitations. This is a single-institution, retrospective study with a

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limited sample size, and thus has all of the inherent biases of such a study. Furthermore, as the

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decision on whether or not to perform EVAR on these patients was operator dependent, there

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may have been a selection bias in who underwent each type of repair. Nearly all of our patients

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had a pre-operative CT scan, suggesting that hemodynamic instability did not play a role in

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procedure selection. Furthermore, all of our surgeons feel comfortable with EVAR in both the

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elective and emergent settings, so this also did not influence the therapy offered.

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CONCLUSION

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This study found that a high-volume, tertiary care center, endovascular repair does not offer

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any survival advantage over open repair of ruptured AAA. While EVAR does lead to a decrease

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in blood loss and transfusion requirement, as well as higher incidence of discharge to home, it is

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also associated with an increased re-intervention rate. These findings suggest that while EVAR

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can be considered in patients with favorable anatomy, shifting to an endovascular-first

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paradigm is currently premature. Furthermore, the overall survival advantage conferred by

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tertiary care centers in the treatment of ruptured AAAs suggests that regionalization of

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treatment may help improve mortality of this condition more than specific operative

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procedure.

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TABLES

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Table 1 Patients Demographics

(n = 99)

(n = 25)

(n = 74)

71.8 ± 8.4

72.4 ± 9.7

89 (89.9)

22 (88.0)

1 (4.0)

11 (14.9)

0.15

10 (40.0)

38 (51.4)

0.33

5 (5.1)

1 (4.0)

4 (5.4)

0.78

4 (4.0)

0 (0)

4 (5.4)

0.24

15 (15.2)

6 (24.0)

9 (12.2)

0.15

6 (6.1)

1 (4.0)

5 (6.8)

0.62

21 (21.2)

3 (12.0)

18 (24.3)

0.19

Coronary artery disease

48 (48.5)

AC C

EP

TE D

12 (12.1)

Diabetes mellitus

Peripheral Artery

0.67

0.72

Stroke

Congestive heart failure

71.6 ± 8.0

67 (90.5)

Comorbidities:

Atrial fibrillation

p-value

RI PT

Open repair

SC

Male Gender, n (%)

Endovascular repair

M AN U

Age (Mean ± SD)

Total

Disease

Chronic Obstructive Pulmonary Disease

ACCEPTED MANUSCRIPT 18

End Stage Renal

4 (4.0)

2 (8.0)

2 (2.7)

0.25

2 (2.0)

0 (0)

2 (2.7)

0.41

3 (3.0)

0 (0)

3 (4.1)

0.31

Prior endovascular aneurysm repair (%)

SC

Prior open aneurysm

RI PT

Disease (%)

repair (%)

M AN U

316

AC C

EP

TE D

317

ACCEPTED MANUSCRIPT 19

318

Table 2. Procedural Data

Endovascular

(n = 99)

(n = 25)

188.5 (154,250)

172 (139,244)

9 (9.1%)

4 (16.0%)

minutes

M AN U

Use of occlusion balloon

Estimated blood loss in

2000 (500,4100)

milliliters

Intravenous fluid

194 (160,256)

5 (6.8%)

0.35

0.22

300 (200,600) 3000 (1500,4600) <0.0001

5 (2,10)

9 (7,17)

0.0041

9.8 (7.1,13.5)

7.5 (3.1,11.6)

10.2 (8.5,14.8)

0.0061

14 (14.1%)

5 (20.0%)

9 (12.2%)

EP

cells transfused

(n = 74)

8 (5,13)

TE D

Units of packed red blood

Open repair

RI PT

repair

SC

Procedural time in

Total

p-value

AC C

administered in liters

Abdomen left open at

0.51

end of case

319

Continuous variables are presented as median (interquartile range), while categorical variables

320

are presented as number (percentage)

321

ACCEPTED MANUSCRIPT 20

Table 3 Perioperative outcomes

Open

Total

repair

repair

(n = 99)

(n = 25)

Total post-op

(n = 74)

SC

5 (2,14)

3 (1.5,15)

M AN U

ICU

p-value

RI PT

Endovascular

Length of Stay* [Median (IQR)]

5 (2,13)

0.38

0.18

14 (6,22)

8.5 (4,21.5)

15 (8,23)

7 (7.1)

6 (24.0)

1 (1.4)

<.0001

7 (7.1)

5 (20.0)

2 (2.7)

0.004

25 (25.3)

8 (32.0)

17 (23.0)

0.37

7 (7.1)

7 (28.0)

0 (0)

<.0001

Acute renal failure (%)

21 (21.1)

2 (8.0)

18 (25.7)

0.06

Atrial fibrillation (%)

11 (11.1)

2 (8.0)

9 (12.2)

0.57

Endoleak (%)

TE D

Reintervention (%)

Complications

EP

Respiratory failure (%)

Abdominal

compartment

AC C

322

syndrome (%)

ACCEPTED MANUSCRIPT 21

Myocardial infarction

4 (4.0)

1 (4.0)

3 (4.1)

0.99

6 (6.1)

1 (4.0)

5 (6.8)

0.62

10 (10.1)

1 (4.0)

9 (12.2)

0.24

Wound dehiscence (%)

Postoperative

RI PT

(%)

(%)

DVT (%)

Lower extremity

EP

323 324

0.56

1 (1.4)

0.09

2 (2.0)

0 (0)

2 (2.7)

0.41

9 (9.1)

2 (8.0)

7 (9.5)

0.83

61 (61.6)

16 (64.0)

45(60.8)

0.82

36 (60.0)

12 (66.7)

24 (57.1)

AC C

Discharged to home (%)**

6 (8.1)

2 (8.0)

Pneumonia (%)

Any complication

3 (12.0)

3 (3.0)

TE D

ischemia (%)

9 (9.1)

M AN U

Intestinal ischemia -

SC

bleeding. (%)

325

* - Excluding patients with LOS < 1 day (n = 10)

326

** - Only those patients who survived to discharge were included

0.03