Accepted Manuscript 30-Day Outcomes Following Elective Percutaneous or Open Endovascular Repair of Abdominal Aortic Aneurysms David S. Kauvar, MD, Eric D. Martin, DO, Matthew D. Givens, MD PII:

S0890-5096(15)00875-4

DOI:

10.1016/j.avsg.2015.10.009

Reference:

AVSG 2632

To appear in:

Annals of Vascular Surgery

Received Date: 25 June 2015 Revised Date:

1 October 2015

Accepted Date: 6 October 2015

Please cite this article as: Kauvar DS, Martin ED, Givens MD, 30-Day Outcomes Following Elective Percutaneous or Open Endovascular Repair of Abdominal Aortic Aneurysms, Annals of Vascular Surgery (2015), doi: 10.1016/j.avsg.2015.10.009. 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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30-Day Outcomes Following Elective Percutaneous or Open Endovascular Repair of Abdominal Aortic Aneurysms (Running head: Percutaneous vs Open EVAR Outcomes)

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David S. Kauvar, MD1,2; Eric D. Martin, DO1; Matthew D. Givens, MD3

1. Department of Surgery, Dwight D. Eisenhower Army Medical Center, Fort Gordon, GA

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2. Uniformed Services University of the Health Sciences, Bethesda, MD

Corresponding Author: David S. Kauvar, MD DDEAMC Department of Surgery

Fort Gordon, GA 30905

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[email protected]

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300 Hospital Drive

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3. Department of Radiology, Dwight D. Eisenhower Army Medical Center, Fort Gordon, GA

The opinions and assertions contained herein are solely those of the authors and do not

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represent those of the United States Government or any entity thereof.

The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

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Abstract Introduction: Percutaneous endovascular aneurysm repair (PEVAR) has become accepted as a suitable alternative to open EVAR (OEVAR) in the treatment of abdominal aortic aneurysms

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(AAA’s). Direct comparisons between the two techniques have been infrequently reported and have predominantly focused on immediate procedural outcomes. The objective of this study was to compare contemporary 30-day postoperative outcomes between successfully completed

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elective PEVAR and OEVAR.

Methods: The 2012 National Surgical Quality Improvement Program (NSQIP) database was

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queried for all elective primary AAA repairs. Procedures on ruptured AAA’s and those involving adjunctive thoracic, abdominal, or extremity procedures were excluded. Cases completed with at least one surgical exposure of the femoral artery for access (OPEN) were compared with those completed without such exposure (PERC). Preoperative, intraoperative, and 30-day postoperative variables were compared using appropriate univariate statistical tests. A P-value

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of ≤ .05 was considered significant for all comparisons.

Results: 1,589 (51%) OPEN and 1533 (49%) PERC cases met inclusion and exclusion criteria. Preoperative characteristics did not differ between groups. OPEN cases took significantly longer

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(150 ± 69 min) than PERC cases (134 ± 65 min, P < .001). No significant differences were found between the groups in any postoperative occurrence, but the rate of venous

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thromboembolism twice as high in OPEN (16, 1.0%) than PERC cases (7, 0.5%, P = .07). Additionally, wound complications (36, 2.3% OPEN vs. 23, 1.3% PERC, P = .11) were more common in OPEN cases, but were diagnosed a week sooner on average in PERC cases (19 days OPEN, 12 days PERC). Median postoperative length of stay was two days among OPEN cases vs. one day in PERC cases (P = .11). Female gender and obesity predicted wound complications in the OPEN group, but not in the PERC group.

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Conclusion: Successfully completed PEVAR and OEVAR have similar rates of overall complications. Female gender and obesity predict wound complications in OEVAR, but not in PEVAR, which appears to be a safe alternative to OEVAR. PEVAR has the advantage of

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shorter operative time and the potential for a shorter postoperative stay, and may offer the

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advantage of fewer wound complications in females and obese patients.

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Introduction Endovascular repair (EVAR) has become the treatment of choice for the vast majority of abdominal aortic aneurysms (AAA’s) over the past two decades.1 The procedure was originally

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performed using open surgical exposure and control of the common femoral arteries for delivery of the graft devices via large diameter sheaths. In 1999, however a technique for percutaneous EVAR (PEVAR) was first reported and has since been accepted as a suitable alternative to

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open EVAR (OEVAR).2 PEVAR offers the opportunity to deliver even large-sheathed devices through the common femoral artery without surgical exposure or repair of the vessel.

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Numerous authors have reported high procedural success and low early complication rates with the PEVAR technique, however with the exception of a single pilot and a single completed randomized trial,3,4 direct comparisons of PEVAR with OEVAR have been sparingly reported and are all from single centers.5-8 Those reports that do compare the two techniques typically focus on the outcomes of conversions from PEVAR to OEVAR and procedural success

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and immediate perioperative outcomes. There are very few reports comparing the postoperative complication rates between technically successful PEVAR and OEVAR. The objective of this study was to use a national multi-institutional surgical outcomes database to

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compare contemporary 30-day postoperative outcomes between successfully completed

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elective PEVAR and OEVAR for abdominal aortic aneurysms.

Methods

Database: The American College of Surgeons maintains the National Surgical Quality Improvement Program (NSQIP) database of surgical outcomes from over 250 nationwide hospitals of all types. Preoperative, perioperative, and up to 30 day postoperative data for most commonly performed surgical procedures are entered on a case-identified basis by trained abstractors at each institution. These data are continuously audited and complied into Participant User Files (PUF’s) containing over 200 data points for all cases performed during a

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calendar year. The PUF’s are made available to participating NSQIP institution for quality improvement and research purposes. Due to the absence of patient identifiers in NSQIP, the Dwight D. Eisenhower Army Medical Center Institutional Review Board exempted this research

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from review. Case Selection: Because the use of PEVAR has increased over the past fifteen years, in order to perform a contemporary comparison of national practices, we elected to sample the 2012

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NSQIP PUF for relevant PEVAR and OEVAR cases. We selected all cases in which the

primary procedure was an endovascular AAA repair with a bifurcated endograft and either one

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docking limb (CPT 34802), two docking limbs (34803), or no docking limbs (34804). Because we were interested in the outcomes of elective procedures, we excluded all cases performed emergently or with a postoperative diagnosis of ruptured AAA. Cases with concomitant thoracic aneurysm repairs were also excluded. Finally we excluded all cases with a secondary procedure requiring a groin incision, including all femoral endarterectomies and bypasses with

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the femoral artery as the inflow or outflow artery.

All cases with at least one secondary procedure code for open femoral artery exposure for endograft delivery (34812) were considered OEVAR, and cases without this code were

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considered PEVAR. This resulted in two groups, one in which the procedure was performed totally percutaneously (PERC-no surgical exposure, conduit placement, endarterectomy, or

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bypass of either femoral artery) and one in which cases had one or more femoral arteries surgically exposed but not for the purpose of endarterectomy, conduit placement, or bypass (OPEN). This case selection rubric eliminated the confounding effect of intraoperative conversions from PERC to OPEN and allowed comparisons of successfully completed PEVAR and OEVAR cases to be made on a patient-by-patient, rather than a groin-by-groin basis. Variables and Analysis: We collected preoperative variables including basic demographic data and comorbidities. Obesity was defined as a body mass index (BMI) ≥ 30 and was treated both as a continuous (BMI) and categorical (obese vs. non obese) variable. Operative variables

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included operative time (in minutes) and type of anesthesia (general vs. local/regional). Postoperative variables reflect a 30-day postoperative data collection period and included mortality, wound complications (including superficial, deep, and organ space infections and

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dehiscences), and other adverse occurrences. Readmission and reoperations within 30 days are categorized in the NSQIP PUF as either related or unrelated to the index procedure and admission and are reported as such.

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Data are reported as mean ± standard deviation for continuous variables and n (%) for categorical variables. Univariate comparisons between groups were performed using Student’s

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t-test for continuous variables and chi-squared or Fisher’s exact tests for categorical variables as appropriate. A P-value of ≤ .05 was considered significant for all comparisons.

Results

The 2012 NSQIP PUF contained 3,118 cases meeting the inclusion and exclusion

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criteria outlined above. Of these, 1,589 (51%) were OPEN and 1533 (49%) were PERC. The population was predominantly elderly and male. Over one-third of the population was obese. Preoperative characteristics between the OPEN and PERC groups did not differ greatly. Most

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procedures were performed under general anesthesia. (Table 1) OPEN cases (150 ± 69 min) took an average of 16 minutes longer than PERC cases

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(134 ± 65 min), and the difference was significant (P < .001). There were 16 deaths in the OPEN group (1.0%) and 20 in the PERC group (1.3%, P = .47). Adverse occurrences were uncommon overall and univariate analysis of postoperative events revealed no significant differences in the rate of any occurrence between the OPEN and PERC groups. The rate of venous thromboembolism was higher for OPEN cases (16, 1.0%), than for PERC cases (7, 0.5%), and this difference trended towards significance (P = .07). The rate of perioperative

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blood transfusion did not differ between the OPEN (130, 8.2%) and PERC (130, 8.4%) groups (P = .81). (Table 2) Wound complications were the most frequently encountered adverse occurrence, and

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were more common in OPEN (36, 2.3%) than in PERC cases (23,1.3%). This difference trended towards significance (P = .11) and was accounted for primarily by a larger number of superficial surgical site infections (27, 1.7%) among the OPEN cases than the PERC cases (16,

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1.0%, P = .11). These superficial surgical site infections were diagnosed an average of 19 days following the procedure in the OPEN group and sooner, at 12 days in the PERC group. The

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finding of earlier detection in the PERC group trend was consistent through all types of wound occurrences. (Table 2)

Postoperative length of stay was modestly longer in the OPEN group (2.5 ± 3.5 days, median 2 days) than in the PERC group (2.3 ± 3.1 days, median 1 day), a finding that trended towards significance (P = .11). The rate of reoperation within 30 days of the index procedure

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was similar between the groups (49, 3.1% OPEN vs. 54, 3.5% PERC, P = .5). Forty (82%) of the OPEN group reoperations and 39 (72%) of the PERC group reoperations were classified as being related to the index procedure. Reoperations occurred an average of 9 days following the

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initial procedure in both groups. The 30-day readmission rates were similar as well (122, 7.7% OPEN vs. 116, 7.6% PERC, P = .89), with 57% of OPEN and 52% of PERC readmissions

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classified as related to the index procedure. (Table 3) Because wound complications were the most frequently observed adverse events in this

study and because lower wound complication rates for PEVAR vs. OEVAR have been observed in previous studies, we examined the univariate predictors of wound complications in the OPEN and PERC groups independently. Thirty-six wound complications were recorded in the OPEN group. Female gender (36% wound complication vs. 18% no wound complication, P = .008) and obesity (64% vs. 38%, .002) were univariate predictors of a wound complication in OPEN

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cases. The mean BMI was also higher for the OPEN group with wound complications (31 ± 7) than for the OPEN group without wound complications (28 ± 6, P < .001). Twenty-three wound complications were observed in the PERC group, but none of the univariate predictors of wound

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complications in the OPEN group, including obesity, were predictors of these occurrences in the PERC group. The mean BMI in PERC patients with wound complications (29 ± 5) was similar to that observed in PERC patients without wound complications (28 ± 6, P = .25). Wound

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complications were more common among women in the OPEN group (4.3% among females vs 1.9% among males, P = .01), but not in the PERC group (1.5% vs 1.6%, P = .82). Similarly,

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wound complications were more common among obese patients in the OPEN group (3.9% among obese vs 1.4% among non-obese, P < 0.001), but not in the PERC group (1.7% vs 1.6%, P = .85).

Discussion

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We used a validated nationwide surgical outcomes database to present the largest comparative analysis of PEVAR versus OEVAR to date. Half of the EVAR’s contained within the 2012 NSQIP PUF were completed percutaneously, and this approach resulted in no

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significant differences in complication rates when compared with the open approach. The PEVAR approach did result in a shorter average operative time and a lower median length of

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postoperative hospital stay. The most frequently reported complications in both the PEVAR and OEVAR cohorts were wound complications, and the risk factors for these differed between the groups.

Most previous reports comparing PEVAR and OEVAR have concentrated on technical

failures and complications directly related to arterial access in PEVAR. These studies present data on the technical success of the procedures and on complications on a “per groin” rather than on a “per patient” basis. Procedural success rates for PEVAR in these studies have

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consistently been greater than 90% and nearly all technical failures and arterial access-related complications have been reported to occur intraoperatively.7,9-12 The novel objective of our analysis was to describe the differences in patient-level postoperative complication rates

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between successfully completed PEVAR and OEVAR using a national surgical outcomes database.

The NSQIP PUF data presented here demonstrate that elective PEVAR and OEVAR

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can be performed with very low rates of 30-day postoperative mortality and complications. Our PEVAR and OEVAR data are comparable to other published NSQIP reports in which the method of arterial access was not delineated with respect to mortality, overall complication

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rates, and the incidence of wound complications.13 The association between female gender and wound complications after EVAR has been previously reported.14 In our study of OEVAR’s, we found twice the percentage of females in the group with wound complications than in the OEVAR group without them. A protective effect of PEVAR against wound complications among

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females has been demonstrated by others,6 and the association between female gender and wound complications was not seen in our PEVAR cohort, suggesting that the percutaneous technique offers some protection against wound complications in female patients.

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Obesity has been shown to be a risk factor for the development of wound complications after EVAR in previous NSQIP reports.15 We observed a similar finding in examining the

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association between BMI and wound complications. Among OEVAR patients with wound complications, the mean BMI was significantly higher than that observed in OEVAR’s without wound complications. Accordingly, the rate of obesity as a binary outcome among OEVAR patients with a wound complication was nearly twice as high as those OEVAR patients without such a complication. Neither BMI nor obesity predicted wound complications in the PEVAR group, again suggesting a protective effect on wound complication rate for the percutaneous approach in obese patients.

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In a number of single-center retrospective series, PEVAR has been demonstrated to be safe and effective, with high technical success rates and low initial failure rates. Like ours, these studies have demonstrated a consistent finding of decreased operative time for PEVAR

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versus OEVAR,5,7 a finding which has been confirmed in a systematic review16 and in a pilot4 and a completed randomized trial.3 Though not statistically significant in our study, the median postoperative length of stay was a day shorter for PEVAR than OEVAR procedures. Shorter lengths of stay for PEVAR have been reported in previous single-center series’ and the finding

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has also been confirmed through systematic review and prospective randomized study.3,4,16

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Though there are no universal contraindications to PEVAR, there have been a number of studies that have identified factors contributing to procedural failure and conversion to open femoral access. The use of ultrasound guidance has been suggested as being associated with technical success in PEVAR.7 Among the anatomic factors consistently associated with PEVAR failure are femoral artery calcification involving > 50% of vessel

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circumference, and femoral artery diameter less than 5mm. 8,12 Open femoral exposure should be considered in patients with these anatomic features. Our finding of no difference in postoperative complication rates between PEVAR and

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OEVAR is similar to that reported in a recent randomized trial comparing the two techniques.3 In that study, major adverse event rates in the first 30 postoperative days were similar between

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the two techniques and, despite less postoperative pain among PEVAR patients, there was no observed difference in patient-reported quality of life at one and six months postoperatively. Our study used a large, national, validated surgical outcomes database to generate data

from a large number of well-selected cases; resulting in nearly equivalent PEVAR and OEVAR groups. Despite this, there are a number of limitations in this analysis. We face the same problem that all large, multi-institutional database research does; the quality of the data generated by analysis of the NSQIP PUF is only as good as the fidelity of the data entry at the hundreds of contributing hospitals. Due to the nature of the data collected by NSQIP, we were

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also unable to determine whether the OPEN and PERC procedures were performed by the same surgeons or at the same institutions. The NSQIP dataset is validated, but there could be errors in data collection that skew our analysis. Additionally, because of the nature of our case

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selection criteria, we were unable to analyze technical complications of PEVAR that resulted in the need for conversion to open femoral exposure, femoral endarterectomy, or surgical bypass due to vessel injury. The effect of this limitation is somewhat mitigated by the fact that most

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such technical failures occur during the primary procedure and our chief interest was in post-

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procedural outcomes.

Conclusion

Successfully completed PEVAR and OEVAR have similar rates of overall complications, most commonly involving the surgical site. Female gender and obesity predict the development of wound complications in OEVAR, but not in PEVAR. PEVAR appears to be a safe alternative

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to OEVAR, with the advantages of less operative time and the potential for a shorter postoperative stay, and may offer the advantage of fewer wound complications in females and

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obese patients.

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P NS NS NS NS NS NS 0.02 0.006 0.02 0.38 NS NS

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PERC (n=1533) 74 +/- 9 1264 (83) 1392 (91) 28.3 +/- 5.9 584 (38) 454 (30) 1190 (78) 288 (1.9) 274 (18) 16 (1.0) 156 (10) 59 (3.5)

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Age (y) Male General Anesthesia BMI (kg/m2) Obesity Smoking Hypertension Diabetes COPD CHF Coronary Revasc TIA/CVA

OPEN (n=1589) 73 +/- 9 1285 (81) 1424 (90) 28.5 +/- 6.0 615 (39) 498 (31) 1281 (81) 240 (1.5) 335 (21) 22 (1.4) 169 (11) 55 (3.5)

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Table 1. Preoperative characteristics of the open (OPEN) and percutaneous (PERC) endovascular aneurysm repair groups. Data are mean ± SD or n (%). BMI, body mass index; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure; Revasc, revascularization; TIA/CVA, transient ischemic attack/cerebrovascular accident.

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P < .001 0.47 0.11 0.11 0.11 NS NS 0.44 0.29 0.66 0.07 0.35 0.81

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OR Time (min) Mortality Wound Complication Superficial Deep Organ Space Dehiscence Pneumonia AKI/Dialysis MI DVT/PE UTI Periop Transfusion

PERC (n=1533) 134 +/- 65 20 (1.3) 23 (1.5) 16 (12 days) 2 (12 days) 1 (2 days) 5 (15 days) 21 (1.4) 11 (0.7) 15 (1.0) 7 (0.5) 31 (2.0) 130 (8.4)

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OPEN (n=1589) 150 +/- 69 16 (1.0) 36 (2.3) 27 (19 days) 4 (20 days) 2 (9 days) 4 (24 days) 17 (1.1) 17 (1.1) 18 (1.1) 16 (1.0) 25 (1.6) 130 (8.2)

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Table 2. Operative and postoperative events in the open (OPEN) and percutaneous (PERC) endovascular aneurysm repair groups. Data are mean ± SD or n (%). MI, myocardial infarction; AKI, acute kidney injury; DVT/PE, deep venous thrombosis/pulmonary embolism; UTI, urinary tract infection; Periop, perioperative (within 24 hours).

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PERC (1533) 2.3 +/- 3.1 (1) 104 (6.8) 104 (6.8) 8.6 days 116 (7.6) 9.5 days

P 0.11 0.13 0.5 0.89

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Postoperative LOS (days) Discharge to Facility Reoperation Time to reoperation Readmission Time to readmission

OPEN (n=1585) 2.5 +/- 3.5 (2) 130 (8.2) 49 (3.1) 9.3 days 122 (7.7) 12.6 days

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Table 3. Discharge characteristics of the open (OPEN) and percutaneous (PERC) endovascular aneurysm repair groups. Data are mean ± SD (median) or n (%). LOS, length of stay.

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