- Email: [email protected]
Ambulatory percutaneous endovascular abdominal aortic aneurysm repair
From the Society for Clinical Vascular Surgery
Ambulatory percutaneous endovascular abdominal aortic aneurysm repair Hasan H. Dosluoglu, MD,a,b Purandath Lall, MBBS,a,c Raphael Blochle, MD,b Linda M. Harris, MD,b and Maciej L. Dryjski, MD,b Buffalo, NY; and San Fernando, Trinidad and Tobago Objective: Percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) has been associated with fewer groin wound complications and shorter operative times, but same-day discharge (SDD) has not been reported. The goal of our article is to assess the feasibility and safety of ambulatory PEVAR and identify patient characteristics that are eligible for this approach. Methods: Consecutive patients who underwent elective endovascular abdominal aortic aneurysm repair (EVAR) between March 2011 and December 2012 were reviewed. SDD was discussed during the preoperative visit with patients who were functionally independent, without significant comorbidities, and had favorable anatomy. These patients were given the option to be discharged in the evening of the PEVAR after 6 hours of bed rest if the procedure was uneventful. Causes for discharge delay and early outcomes were analyzed. Results: During the study period, 79 patients underwent abdominal aortic aneurysm (AAA) repair, 64 of whom (mean age, 70.2 6 9.9; range, 59-97) had elective EVAR (3 ruptures, 5 acute presentations, 3 fenestrated EVARs, 4 elective open AAA repairs were excluded). Fifty-three patients (83%) had bilateral percutaneous access, seven had unilateral percutaneous (11%) access, and the remaining four (6%) had bilateral femoral endarterectomies. The percutaneous closure success rate was 96% in 113 attempts (three conversions for inadequate hemostasis, one for inability to deploy device). Mean length of stay was 1.3 6 1.4 days (median, 1 day) with no 30-day mortality. Twenty-one patients (33%) were discharged the same day (SDD group), 24 (37%) on postoperative day (POD) 1, 16 (25%) on POD 2/3, and 3 (5%) stayed $4 days. One patient in the SDD group was readmitted on POD 3 after EVAR for severe postimplantation syndrome. Of the 23 patients who were discharged on POD 1, 10 were kept overnight due to severe chronic obstructive pulmonary disease, coronary artery disease, or advanced age, three transportation issues, two inability to void, two patient preference, two for renal protection, and four due to unplanned femoral cutdown. Patients in the SDD group were significantly younger (66.5 6 5.4 years vs 72.0 6 10.6 years; P [ .029), had smaller AAAs (5.3 6 0.5 cm vs 5.9 6 1.0 cm; P [ .013), less blood loss (115 6 90 mL vs 232 6 198 mL; P [ .012), and shorter operating time (79 6 24 minutes vs 121 6 73 minutes; P [ .013). There were fewer American Society of Anesthesiologists 4 patients in the SDD group (24% vs 48%; P [ .056). The majority (81%) of patients in all groups had general anesthesia (86% vs 79% SDD vs others; P [ .523). Conclusions: Ambulatory PEVAR was found to be feasible and safe in one-third of patients undergoing elective EVAR who did not have excessive medical risk, had good functional capacity, and underwent an uneventful procedure. The impact of SDD on cost-effectiveness needs to be further assessed and may not be feasible in hospitals reimbursed based on admission status. (J Vasc Surg 2014;59:58-64.)
Endovascular abdominal aortic aneurysm repair (EVAR) is associated with decreased perioperative mortality and
From the Division of Vascular Surgery, Veterans Affairs Western New York Healthcare System, Buffaloa; Division of Vascular Surgery, Department of Surgery, State University of New York at Buffalo, Buffalob; and the Division of Vascular Surgery, South West Regional Health Authority, San Fernando.c This material is the result of work supported with the resources and the use of facilities at the Veterans Affairs Western New York Healthcare System. The contents of this paper do not represent the views of the Department of Veterans Affairs or the United States Government. Author conflict of interest: none. Presented at the Forty-first Annual Symposium of the Society for Clinical Vascular Surgery, Miami, Fla, March 12-16, 2013. Reprint requests: Hasan H. Dosluoglu, MD, Division of Vascular Surgery, Veterans Affairs Western New York Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214/$36.00 Copyright Ó 2014 by the Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jvs.2013.06.076
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morbidity, blood loss, and length of stay (LOS) compared with open aneurysm repairs in randomized and nonrandomized trials.1-3 In addition, EVAR has comparable long-term outcomes,4 even in those with challenging anatomy.5 In an effort to further decrease morbidity, percutaneous EVAR (PEVAR) has been introduced using a variety of closure devices and has been reported to have fewer groin wound complications, decreased operation times, and time to ambulation.6 However, impact on LOS has been modest, with a mean of 3.5 days in open access compared to 2.7 days in those who had PEVAR in studies comparing both approaches.7-9 The overall cost of EVAR has been reported to be higher than open repair mainly due to device costs, surveillance imaging and reinterventions10,11; however, the cost analysis of the Open vs Endovascular Repair (OVER) trial reported that in-hospital costs were lower with EVAR persisting up to 2 years.12 Since device costs are somewhat fixed, decreasing intensive care and overall hospital LOS and wound complications would further decrease the cost of EVAR. Al-Zuhir et al13 reported that by implementing a protocol of identifying patients for short-stay EVAR, about
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27% of patients could be discharged on the first postoperative day (POD), resulting in significant cost reduction. We started using PEVAR in 2005 with the double Proglide technique and observed that all closure failures were identified and addressed in the operating room (OR), and emergency reintervention after surgery was not required in any patient.14 We also observed that patients who develop moderate to severe postimplantation syndrome (PIS) have extended LOS despite needing only supportive care, as reported by others.15 Consequently, we started offering same-day discharge (SDD) after PEVAR beginning in March 2011. The goal of this study was to assess the feasibility and safety of ambulatory PEVAR in selected patients and identify the characteristics of these patients. METHODS Design and methodology. All patients who underwent EVAR in the Veterans Affairs Western New York Healthcare System between March 1, 2011 and December 31, 2012 were identified from our prospectively maintained database, and the data were retrospectively analyzed. Demographics, comorbidities, clinical presentation, aneurysm characteristics (size, neck diameter, neck length, characteristics [shape, calcification, clot], tortuosity, iliac diameter), operative details, postoperative course, intensive care unit (ICU) and overall LOS, and follow-up clinical and imaging data were recorded. Comparisons were made between those who were discharged on the day of EVAR (SDD), POD 1, and later. Patients who had uneventful EVAR with no type I or III endoleaks had one postoperative clinic visit 2 weeks after surgery, computerized tomography (CT) imaging with contrast at 6 months, and the every 12 months imaging with either ultrasonography or CT without contrast if they had no endoleak or sac expansion. Patients with endoleak or sac expansions were monitored with CT every 6 months. CT imaging and clinical examination were used to assess the femoral arteries. EVAR procedures. Planning and graft selection was performed by vascular surgeons based on anatomic characteristics of the abdominal aortic aneurysm (AAA). Four Food and Drug Administration-approved devices were used during the study period (Zenith; Cook Inc, Bloomington, Ind; Excluder; Gore Inc, Newark, Del; AFX; Endologix Inc, Irvine, Calif; and Endurant; Medtronic Inc, Minneapolis, Minn). Percutaneous EVAR was planned except in those who needed femoral endarterectomy (FEA) for bulky occlusive disease, femoral aneurysm repair, or excessive calcification of the anterior femoral artery wall. Femoral access was obtained with micropuncture, and access angiogram was obtained via microcatheter before dilating the tract. Most recently, ultrasound-guided access was used to optimize initial puncture site selection. Preclose/double Proglides (Abbott, Inc, Abbott Park, Ill) technique was used,14 with the modification of minimal angulation of the Proglides (10 ). After EVAR completion, the sutures were tied, starting from the larger access site. If there was continued oozing after the second Proglide was
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tied, and bleeding was controlled by reinsertion of a 6 to 7F sheath, a third Proglide was placed. In patients without adequate hemostasis, a small cutdown was made after large sheath reinsertion, and fascial closure was achieved using 3/0 prolene.16 The femoral artery was fully dissected and repaired only if fascial closure failed. General anesthesia was preferentially used except for those deemed excessively high risk, in whom local anesthesia with sedation was used. The EVAR procedures were performed in standard fashion as recommended by the instructions for use for each of the grafts. Patients received 80 U/kg of intravenous heparin after femoral arteries were accessed, and heparin was reversed using 20- to 30-mg protamine after confirming no change in pedal pulses. Approach. Our first patient in this series was offered discharge without prior planning or discussion, as he appeared very comfortable postoperatively. However, after the initial favorable experience, we started discussing the option of SDD for patients with favorable anatomy, good renal function with no plans for intravenous hydration postoperatively, those who were not medically high risk, had good functional capacity, lived independently, and had someone to stay with them the night of surgery. Medically high risk included severe chronic obstructive pulmonary disease (COPD) on home oxygen, congestive heart failure, or advanced age (>80 years). Patients who lived more than 50 miles from the hospital or in a rural setting were not considered for discharge, as we do not have access to a closer monitored accommodation setup. We also scheduled SDD PEVAR procedures before noon to allow time for observation. SDD was again discussed in preoperative holding, and pedal pulses were checked for verification of baseline status. Patients were informed that they could be discharged if we had no concerns regarding the repair (satisfactory, uneventful placement of endograft, good hemostasis, no intraoperative events), closure or medical condition. A Foley catheter was placed in all patients and removed in the OR after procedure completion. Patients were observed in the postanesthesia care unit for 2 hours and were then either transferred to floor to be discharged later, or, in the latter part of the study, directly to the ambulatory surgery unit, decreasing paperwork associated with admission and discharge. Patients were discharged if they could ambulate without difficulty and voided. In addition to routine instructions, patients were advised to take acetaminophen if they developed a low-grade fever, or mild back pain, and to hydrate as much as possible. Definitions. Functional capacity was considered to be poor if the patient’s exercise tolerance was estimated to be <4 metabolic equivalents during their preoperative evaluation, as described by the Duke Activity Status Index17 and the American Heart Association exercise index.18 PIS was defined as any combination of the following: fever >100 F, white blood cell count >10,000/mm3, abdominal and/or back pain, or other nonspecific symptoms such as malaise or loss of appetite. Renal insufficiency was defined as an estimated glomerular filtration rate <60 mL/min/ 1.73 m2. The definitions in the reporting standards by the
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Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/ American Association for Vascular Surgery19 were used for endoleak, technical success, and other aneurysm-related events. Statistical analysis. Data analysis was performed using SPSS 18.0 software (SPSS Inc, Chicago, Ill). Continuous variables are given as mean 6 standard deviation. Demographic comparisons were made using c2 test for categorical variables, and by t-test for continuous variables. All P values were considered significant if <.05. The study was approved by the Institutional Review Board for Research at the Buffalo Veterans Affairs, and informed consent was waived due to the retrospective nature of the study. RESULTS A total of 79 male patients underwent AAA repair. The study population included 64 patients, as 15 were excluded (three ruptures [two open, one EVAR], five acute presentations [all EVAR], three fenestrated EVARs, and four elective open repairs). In the study group (n ¼ 64), one patient had blue toe syndrome, and four patients had disabling claudication due to their iliac occlusive disease and had AAA repair in combination with intervention for their occlusive iliac disease. The remaining 59 patients had no aneurysm-related or unrelated symptoms. Mean AAA diameter was 5.7 6 0.9 cm (range, 4.0-10.0 cm). Demographics, comorbidities, and anatomic characteristics are listed in Tables I and II. Overall, 54 (84%) had bilateral percutaneous attempts, seven (11%) had unilateral percutaneous attempts (six FEA/patch, one had planned femoral cutdown for access due to calcification), and three (5%) patients had bilateral femoral cutdowns (two had FEA/patch, one cutdown to prevent emboli). The success rate for PEVAR was 96% (100% for 9-16F, 93% for 17-22F sheaths) for attempted closures, and 94% for 54 patients in whom bilateral PEVAR was attempted. All four conversions occurred in patients with bilateral PEVAR attempts (two in 17F and two in 22F sheaths). One conversion occurred because of the inability to deploy the closure device due to vessel calcification. The remaining three patients had inadequate hemostasis after device deployment. Two were managed with femoral fascial closures, and one needed a femoral patch. Overall, 81% of the procedures were performed under general anesthesia, while 19% had local anesthesia with moderate sedation. The grafts used were Zenith (Cook Inc) in 16 (25%), Excluder (Gore Inc) in 17 (27%), AFX (Endologix Inc) in 21 (33%), and Endurant (Medtronic Inc) in 10 (16%). A total of 35 adjunctive procedures were used in 18 (28%) patients, three of whom were in the SDD group (Table III). None of the patients in this cohort needed blood transfusion, and the operative details are listed in Table II. Twenty-one (33%) patients were discharged on the same day, 23 (36%) were discharged on POD 1 (10 [16%] with 23-hour observation status, 13 [20%] as full admit), 17
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(27%) were discharged on POD 2/3 (11 on POD 2, 6 on POD 3), and the remaining three (5%) were discharged between POD 4 to 6. The mean LOS was 1.3 6 1.4 days (median 1 day), and mean ICU stay was 0.1 6 0.4 days (five stayed 1 day, two stayed 2 days). The mean LOS in patients treated percutaneously was 1.0 6 1.1 days. There was no 30-day mortality. Postoperative complications were observed in 11 (17%) patients (Table IV). There was one hematoma in the PEVAR-treated patients in the SDD group, which resolved spontaneously. The reasons for the 23 patients in the POD 1 discharge group to stay overnight, rather than being discharged on the same day, were poor medical condition in 10 (severe COPD with home O2 in 5, ischemic cardiomyopathy in 2, advanced age in 3), transportation issues in three (two lived >100 miles away, one had no transportation), patient preference in one, inability to void in two, poor renal function necessitating intravenous hydration and urine output monitoring in two, and femoral cutdown in four. PIS occurred in 15 patients (23%), four in the SDD group (19%), and 11 in the non-SDD groups (26%). In the SDD group, this was reported to have occurred by patients during postoperative clinic visits, without objective testing. The incidence was 31% in patients who had Zenith (Cook Inc), 12% in Excluder (Gore Inc), 10% in AFX (Endologix Inc), and 60% in Endurant (Medtronic Inc) grafts (P ¼ .009). The only unplanned readmission occurred in the SDD group because of severe PIS on POD 3. The patient presented with back pain, increased white blood cell count (14,000/mm3), and fever (100 F). He was medically managed with hydration, pain control, and anti-inflammatory medications and was discharged after 3 days. Of the 11 patients in the nonSDD group with PIS, 3 were discharged on POD 1, 5 were discharged on POD 2, and 3 were discharged on POD 3. PIS was the only reason for delayed discharge in five patients, three of whom were discharged on POD 2, and two on POD 3. The demographic characteristics, comorbidities, anatomic features and operative details of patients in the SDD group, POD 1 group and POD $ 2 group are compared in Tables I and II. Patients in the SDD group were significantly younger (66.5 6 5.4 years vs 72.0 6 10.6 years; P ¼ .029), had smaller AAAs (5.3 6 0.5 cm vs 5.9 6 1.0 cm; P ¼ .013), less blood loss (115 6 90 mL vs 232 6 198 mL; P ¼ .012), and required shorter operating time (79 6 24 minutes vs 121 6 73 minutes; P ¼ .013). There were fewer American Society of Anesthesiologists class 4 patients in the SDD group (24% vs 48%; P ¼ .056) and fewer on home O2 than patients discharged on POD 1 (5% vs 30%; P ¼ .027). All patients in the SDD group had successful total PEVAR. The mean follow-up after the index procedure was 8.3 6 6.6 (range, 1-24) months. There were no aneurysm-related mortalities. Four patients died (three in POD 1, one in POD 2 groups), three from cancer at 3, 6, and 13 months, and one from multiple system organ
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Table I. Demographics and comorbidities of patients
Age, years CAD CHF Hypertension DM CVD Hyperlipidemia COPD Home O2 Active smoker Renal (eGFR <60) ASA class 4 Beta-blocker Statin ACEI ECASA Clopidogrel Warfarin
Overall (n ¼ 64)
SDD (n ¼ 21)
POD 1 (n ¼ 23)
POD $ 2 (n ¼ 20)
70.2 6 9.9 (59-97) 50 11 75 23 15 91 45 17 46 22 39 59 72 55 86 9 19
66.5 6 5.4 (59-79) 48 10 86 24 14 95 33 5 35 14 24 57 57 71 95 5 10
71.0 6 9.0 (61-87) 52 9 78 26 17 91 57 30 50 17 48 65 83 43 91 0 22
73.1 6 12.4 (59-97) 50 15 60 20 11 85 45 15 53 35 50 55 75 50 70 25 25
P .029a .955 .779 .148 .894 .851 .526 .304 .027b .405 .224 .056a .768 .160 .156 .044c .013c .402
ACEI, Angiotensin-converting enzyme inhibitor; ASA, American Society of Anesthesiologists; CAD, coronary artery disease; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CVD, cerebrovascular disease; DM, diabetes mellitus; ECASA, enteric-coated acetylsalicylic acid; eGFR, estimated glomerular filtration rate; POD, postoperative day; SDD, same-day discharge. Continuous data are presented as mean 6 standard deviation (range) and categoric data as percentage. a SDD vs other groups. b SDD vs POD 1. c POD $ 2 vs other groups.
Table II. Aneurysm characteristics and operative details in groups
AAA diameter Neck diameter Neck length High-risk neck Adjuncts, no FEA Adjuncts, FEA EBL, mL Transfusion OR time, minutes Total percutaneous. Unilateral percutaneous Bilateral cutdown General anesthesia
Overall (n ¼ 64)
SDD (n ¼ 21)
POD 1 (n ¼ 23)
POD $ 2 (n ¼ 20)
5.7 6 0.9 (4.0-10.0) 25.4 6 3.7 (18-34) 24.0 6 10.6 (5-50) 23 17 28 194 6 178 (20-1000) 0 107 6 64
5.3 6 0.5 (4.0-6.5) 25.0 6 2.6 (19-30) 26.2 6 11.4 (8-40) 19 14 14 115 6 90 (20-300) 0 79 6 24 (50-132) 100 0 0 86
5.8 6 0.6 (4.0-7.2) 25.1 6 3.8 (21-34) 21.7 6 10.4 (5-50) 35 22 26 196 6 118 (50-500) 0 99 6 50 (52-265) 74 22 4 78
6.1 6 1.3 (4.5-10.0) 23.9 6 5.3 (18-33) 24.2 6 9.7 (12-40) 15 15 45 275 6 259 (25-1000) 0 147 6 88 (55-341) 60 30 10 80
84 11 5 81
P <.02a NS NS .263 .769 .031b <.015a <.04b .016a .05a .316 .806
AAA, Abdominal aortic aneurysm; EBL, estimated blood loss; FEA, femoral endarterectomy; NS, not significant; OR, operating room; POD, postoperative day; SDD, same-day discharge. Continuous data are presented as mean 6 standard deviation (range) and categoric data as percentage. a SDD vs others. b POD $ 2 vs SDD.
failure at 15 months. There were no type I or III endoleaks, but four type II endoleaks persisting after 6 months, three of whom had 2- to 4-mm sac diameter increase and are being monitored. One patient presented with left leg
embolization and had Fogarty thrombectomy followed by relining of iliac limb with stent graft. One patient started dialysis at 15 months (baseline estimated glomerular filtration rate 17 mL/min/1.73 m2).
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Table III. Adjuncts used during endovascular AAA repair in 18 patients Aneurysm related Proximal cuff IIA coil embolization Bell-bottom iliac >20 mm IIA ostium coverage Sac embolization EIA stent Renal stent Access related Transbrachial access FEA EIA-IIA bypass
5 4a 1 2 2 3 7b 1 9 1
AAA, Abdominal aortic aneurysm; EIA, external iliac artery; FEA, femoral endarterectomy; IIA, internal iliac artery; SDD, same day discharge. a One patient in the SDD group. b Two patients in the SDD group.
Table IV. Postoperative complications Buttock claudication Hematoma Urinary retention Inguinal neuritis Prolonged ileus Arrhythmia Hematuria CHF exacerbation, reintubation PIS
1 1 4 1 1 1 1 1 15
(2) (2) (6) (2) (2) (2) (2) (2) (23)
CHF, Congestive heart failure; PIS, postimplantation syndrome. Data are presented as number (%).
DISCUSSION Our study showed that about one-third of patients who undergo EVAR can be safely discharged home after a 6-hour observation period, despite the use of general anesthesia in the majority of patients. This is the first report on ambulatory PEVAR, with the shortest reported mean LOS in a consecutive patient series. With more widespread PEVAR and decreased device profiles of available EVAR devices, this approach is likely to become more attractive. PEVAR has been increasing since its introduction in the late 1990s.20 In the National Surgical Quality Improvement Program database, 44% of 6009 patients who underwent elective EVAR between 2005 and 2008 were treated percutaneously.21 The Preclose/double Proglide technique was first reported in 2007 and is the technique we utilize.14,22 The advantages of Proglide include its lower cost and nonbraided suture. There is a steep learning curve to PEVAR,23,24 and ambulatory PEVAR should not be considered by surgeons still on the learning curve of PEVAR. The advantage of PEVAR over femoral cutdown includes fewer groin wound complications, decreased operative time, and decreased time to ambulation.6 In a systematic review of 22 papers involving 1087 patients (1751 groins), overall success was 92%, decreasing with an increase in sheath size.6 Operative time was shorter (106 vs 145 minutes, weighted mean) in PEVAR than open
exposure with five of eight studies reporting significant differences. Time to ambulation was also shorter in PEVAR, with 81% of patients ambulating within 6 hours in one study.25 Hospital stay was also decreased in PEVAR with a mean of 2.07 days. However, the cost of PEVAR was similar between groups, as the device costs were not adequately compensated by decreased procedural time in these series. None of these studies, however, has explored the effect of reduced hospital stay on overall cost. In more recent series, the mean LOS has been reported to be between 1.4 to 3.1 days.26,27 We report the shortest mean LOS for PEVAR with 1.0 6 1.1 days. PEVAR is likely to reduce readmission rates. Similar to open AAA repair, the most common reason for readmission after both EVAR/PEVAR was wound complications in a 5% random sample of Medicare beneficiaries (1502 patients) between 2004 and 2006.28 The only readmission observed in our SDD cohort occurred from severe PIS in one patient 3 days after discharge. Arnaoutoglou et al reported readmission for severe PIS within 30 days in six out of 162 patients, two of whom needed ICU admission for medical management.15 PIS was noted to be less frequent in our patients who had polytetrafluoroethylene-based grafts (10%-12%) than Dacron grafts (31%-60%). This association has been reported by others and is likely valid.29,30 Although PIS is generally inconsequential, it frequently delays discharge and increases cost in hospitalized patients. PIS was the cause for further delay in discharge in five of our hospitalized patients, two of whom stayed until POD 3. We have found the best way to avoid unnecessary discharge delays is to discharge patients home on the day of surgery with instructions for acetaminophen or ibuprofen and oral hydration. Few patients are likely to need readmission due to severe PIS. Anesthetic technique has been suggested to have an impact on postoperative morbidity and LOS. In an analysis of 6009 patients who underwent EVAR between 2005 and 2008, general anesthesia was associated with increased pulmonary morbidity and LOS compared with spinal or local anesthesia.21 Of note, 46% and 40% of the patients in general and local anesthesia had the procedures performed percutaneously, whereas these were 38% and 28% in the spinal and epidural anesthesia groups, respectively. In a review of 10 studies involving 13,459 patients comparing local anesthesia with general anesthesia, patients who had local anesthesia had shorter operative times, shorter LOS, and fewer postoperative complications, although percutaneous procedures were found to be performed more frequently under general anesthesia.31 In our series, local anesthesia was the preferred approach for high-risk patients, especially those with severe COPD. The vast majority (86%) of SDD patients had general anesthesia, which was similar in all groups. Although local anesthesia with sedation is feasible, inability to reliably suspend breathing during graft deployment, and some patient discomfort during sheath manipulation or relative limb ischemia, leads to our preference for general anesthesia. This has not impacted LOS, similar to patients having minimally invasive laparoscopic procedures
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with SDD.32 Thus, it seems that the invasiveness of the procedure, rather than the type of anesthesia, determines suitability for SDD. One potential concern of sending patients home on the same day is life-threatening bleeding or limb ischemia after discharge. In our experience, all percutanous failures occurred in the OR, with no patient returning to the OR in the early or late postoperative period, similar to previous reports.7,22 In the large series by Lee et al,22 15 of the 16 early failures occurred intraoperatively, with one patient requiring late (POD 27) repair from a necrotizing groin infection. In Borner et al’s series,33 15 of 17 failures were addressed in the OR, and two returned for bleeding within 24 hours. The authors suggest that these two failures occurred early in their series, did not have adequate hemostasis, and in retrospect, should have been repaired intraoperatively. We cannot emphasize enough that hemostasis and pedal perfusion should be completely satisfactory before consideration for SDD. Therefore, performing these procedures in an outpatient center setting would be challenging since the adequacy of hemostasis and distal perfusion cannot be guaranteed prior to procedure completion, even by those with extensive experience. Device cost is the main component driving overall cost of EVAR. The associated decreased duration of surgery, ICU and overall LOS, decreased blood product usage, and laboratory tests have been proposed to not adequately counteract these costs, especially in early studies.11,12 Since device costs are outside of surgeons’ control, decreasing LOS remains the main component on which cost decrease can be accomplished. In the study by Al-Zuhir et al,13 increase in short-stay EVAR cases from 30% to 45% in the first and second half of the study resulted in a decrease in overall costs of approximately £2,000. In the OVER trial, the hospital cost was $5900 less in the EVAR group, despite a mean LOS of 5.0 days, which was significantly less than open (10.5 days; P < .001).12 Even with surveillance studies and reinterventions, EVAR remained less costly during follow-up in the OVER trial and in a costeffectiveness analysis by Hayes et al.34 The decreased frequency of postoperative surveillance and ultrasoundbased surveillance adopted by many centers will likely result in increased cost-efficiency of EVAR over open AAA repair.35,36 The current study was conducted in the Veterans Affairs System, and the hospital reimbursement for these procedures was not affected by patients’ ambulatory status. This may not be applicable to the private sector, currently, and would potentially result in a financial loss, as hospitals may not be reimbursed for outpatient devices with outpatient EVAR procedures. Until Centers for Medicare and Medicaid Services allows coding for these devices in an outpatient setting, ambulatory PEVAR will not be feasible in private sector hospitals. We believe that SDD may be feasible in about 40% of EVAR cases if transportation and home issues are resolved preoperatively. The remaining 60% patients are unlikely to be candidates for SDD, as their factors for hospitalization
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are not modifiable, or in some cases, unpredictable, such as inability to void after the procedure.13 Although identification of high-risk patients for failure to void could potentially help for planning of discharge, this would likely not have a significant impact on overall LOS. The limitations of our study include its retrospective nature and lack of a strict protocol for a relatively small number of patients undergoing EVAR for the selection of ambulatory PEVAR. However, patients were approached in a uniform fashion, and our results are easily reproducible in centers with experience in PEVAR procedures. We also did not study the cost savings; however, it is hard to dismiss the potential savings associated with decreased LOS and decreased laboratory tests. Our approach did help our hospital by decreasing bed requirements, as inpatient beds are scarce, not infrequently resulting in patients waiting admission in the emergency room, or being diverted. CONCLUSIONS In this study, we found that ambulatory PEVAR is feasible and safe in one-third of patients undergoing elective EVAR, who do not have excessive medical risk, have good functional capacity, and have undergone an uneventful procedure. Its impact on cost-effectiveness needs to be further assessed and may not be applicable currently in non-VA hospitals. AUTHOR CONTRIBUTIONS Conception and design: HD, PL Analysis and interpretation: HD, PL, RB, LH, MD Data collection: HD Writing the article: HD Critical revision of the article: HD, PL, RB, LH, MD Final approval of the article: HD, PL, RB, LH, MD Statistical analysis: HD Obtained funding: Not applicable Overall responsibility: HD REFERENCES 1. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009;302:1535-42. 2. EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet 2005;365:2179-86. 3. Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, et al. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg 1999;29:292-305. 4. Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, et al; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med 2012;367:1988-97. 5. Turnbull IC, Criado FJ, Sanchez L, Sadek M, Malik R, Ellozy SH, et al. Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg 2010;51:537-44.
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6. Malkawi AH, Hinchliffe RJ, Holt PJ, Loftus IM, Thompson MM. Percutaneous access for endovascular aneurysm repair: a systematic review. Eur J Vasc Endovasc Surg 2010;39:676-82. 7. Morasch MD, Kibbe MR, Evans ME, Meadows WS, Eskandari MK, Matsumura JS, et al. Percutaneous repair of abdominal aortic aneurysm. J Vasc Surg 2004;40:12-6. 8. McDonnell CO, Forlee MV, Dowdall JF, Colgan MP, Madhavan P, Shanik GD, et al. Percutaneous endovascular abdominal aortic aneurysm repair leads to a reduction in wound complications. Ir J Med Sci 2008;177:49-52. 9. Jean-Baptiste E, Hassen-Khodja R, Haudebourg P, Bouillanne PJ, Declemy S, Batt M. Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study. Eur J Vasc Endovasc Surg 2008;35:422-8. 10. Dryjski M, O’Brien-Irr MS, Hassett J. Hospital costs for endovascular and open repair of abdominal aortic aneurysm. J Am Coll Surg 2003;197:64-70. 11. Angle N, Dorafshar AH, Moore WS, Quiñones-Baldrich WJ, Gelabert HA, Ahn SS, et al. Open versus endovascular repair of abdominal aortic aneurysms: what does each really cost? Ann Vasc Surg 2004;18:612-8. 12. Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg 2012;56:901-9. 13. Al-Zuhir N, Wong J, Nammuni I, Curran G, Tang T, Varty K. Selection, Thirty Day Outcome and Costs for Short Stay Endovascular Aortic Aneurysm Repair (SEVAR). Eur J Vasc Endovasc Surg 2012;43: 662-5. 14. Dosluoglu HH, Cherr GS, Harris LM, Dryjski ML. Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose Proglide closure devices. J Endovasc Ther 2007;14:184-8. 15. Arnaoutoglou E, Papas N, Milionis H, Kouvelos G, Koulouras V, Matsagkas MI. Postimplantation syndrome after endovascular repair of aortic aneurysms: need for postdischarge surveillance. Interact Cardiovasc Thorac Surg 2010;11:449-54. 16. Larzon T, Geijer H, Gruber G, Popek R, Norgren L. Fascia suturing of large access sites after endovascular treatment of aortic aneurysms and dissections. J Endovasc Ther 2006;13:152-7. 17. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, et al. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 1989;64:651-4. 18. Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, et al. American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgeryeexecutive summary a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2002;105:1257-67. 19. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002;35:1048-60. 20. Haas PC, Krajcer Z, Diethrich EB. Closure of large percutaneous access sites using the Prostar XL Percutaneous Vascular Surgery device. J Endovasc Surg 1999;6:168-70. 21. Edwards MS, Andrews JS, Edwards AF, Ghanami RJ, Corriere MA, Goodney PP, et al. Results of endovascular aortic aneurysm repair with
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general, regional and local/monitored anesthesia care in the American College of Surgeons National Surgical Quality Improvement Program database. J Vasc Surg 2011;54:1273-82. Lee WA, Brown MP, Nelson PR, Huber TS. Total percutaneous access for endovascular aortic aneurysm repair (“Preclose” technique). J Vasc Surg 2007;45:1095-101. Bechara CF, Barshes NR, Pisimisis G, Chen H, Pak T, Lin PH, et al. Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair. J Vasc Surg 2013;57:72-6. Eisenack M, Umscheid T, Tessarek J, Torsello GF, Torsello GB. Percutaneous endovascular aortic aneurysm repair: a prospective evaluation of safety, efficiency, and risk factors. J Endovasc Ther 2009;16: 708-13. Quinn SF, Kim J. Percutaneous femoral closure following stent-graft placement: use of the Perclose device. Cardiovasc Intervent Radiol 2004;27:231-6. Bensley RP, Hurks R, Huang Z, Pomposelli F, Hamdan A, Wyers M, et al. Ultrasound-guided percutaneous endovascular aneurysm repair success is predicted by access vessel diameter. J Vasc Surg 2012;55: 1554-61. Heyer KS, Resnick SA, Matsumura JS, Amaranto D, Eskandari MK. Percutaneous Zenith endografting for abdominal aortic aneurysms. Ann Vasc Surg 2009;23:167-71. Greenblatt DY, Greenberg CC, Kind AJ, Havlena JA, Mell MW, Nelson MT, et al. Causes and implications of readmission after abdominal aortic aneurysm repair. Ann Surg 2012;256:595-605. Moulakakis KG, Alepaki M, Sfyroeras GS, Antonopoulos CN, Giannakopoulos TG, Kakisis J, et al. The impact of endograft type on inflammatory response after endovascular treatment of abdominal aortic aneurysm. J Vasc Surg 2013;57:668-77. Voûte MT, Bastos Gonçalves FM, van de Luijtgaarden KM, Klein Nulent CG, Hoeks SE, Stolker RJ, et al. Stent graft composition plays a material role in the postimplantation syndrome. J Vasc Surg 2012;56: 1503-9. Karthikesalingam A, Thrumurthy SG, Young EL, Hinchliffe RJ, Holt PJ, Thompson MM. Locoregional anesthesia for endovascular aneurysm repair. J Vasc Surg 2012;56:510-9. Ahmad NZ, Byrnes G, Naqvi SA. A meta-analysis of ambulatory versus inpatient laparoscopic cholecystectomy. Surg Endosc 2008;22: 1928-34. Börner G, Ivancev K, Sonesson B, Lindblad B, Griffin D, Malina M. Percutaneous AAA repair: is it safe? J Endovasc Ther 2004;11:621-6. Hayes PD, Sadat U, Walsh SR, Noorani A, Tang TY, Bowden DJ, et al. Cost-effectiveness analysis of endovascular versus open surgical repair of acute abdominal aortic aneurysms based on worldwide experience. J Endovasc Ther 2010;17:174-82. Bastos Gonçalves F, van de Luijtgaarden KM, Hoeks SE, Hendriks JM, ten Raa S, Rouwet EV, et al. Adequate seal and no endoleak on the first postoperative computed tomography angiography as criteria for no additional imaging up to 5 years after endovascular aneurysm repair. J Vasc Surg 2013;57:1503-11. Gray C, Goodman P, Herron CC, Lawler LP, O’Malley MK, O’Donohoe MK, et al. Use of color duplex ultrasound as a first line surveillance tool following EVAR is associated with a reduction in cost without compromising accuracy. Eur J Vasc Endovasc Surg 2012;44: 145-50.
Submitted Apr 30, 2013; accepted Jun 26, 2013.
Ambulatory percutaneous endovascular abdominal aortic aneurysm repair Hasan H. Dosluoglu, MD,a,b Purandath Lall, MBBS,a,c Raphael Blochle, MD,b Linda M. Harris, MD,b and Maciej L. Dryjski, MD,b Buffalo, NY; and San Fernando, Trinidad and Tobago Objective: Percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) has been associated with fewer groin wound complications and shorter operative times, but same-day discharge (SDD) has not been reported. The goal of our article is to assess the feasibility and safety of ambulatory PEVAR and identify patient characteristics that are eligible for this approach. Methods: Consecutive patients who underwent elective endovascular abdominal aortic aneurysm repair (EVAR) between March 2011 and December 2012 were reviewed. SDD was discussed during the preoperative visit with patients who were functionally independent, without significant comorbidities, and had favorable anatomy. These patients were given the option to be discharged in the evening of the PEVAR after 6 hours of bed rest if the procedure was uneventful. Causes for discharge delay and early outcomes were analyzed. Results: During the study period, 79 patients underwent abdominal aortic aneurysm (AAA) repair, 64 of whom (mean age, 70.2 6 9.9; range, 59-97) had elective EVAR (3 ruptures, 5 acute presentations, 3 fenestrated EVARs, 4 elective open AAA repairs were excluded). Fifty-three patients (83%) had bilateral percutaneous access, seven had unilateral percutaneous (11%) access, and the remaining four (6%) had bilateral femoral endarterectomies. The percutaneous closure success rate was 96% in 113 attempts (three conversions for inadequate hemostasis, one for inability to deploy device). Mean length of stay was 1.3 6 1.4 days (median, 1 day) with no 30-day mortality. Twenty-one patients (33%) were discharged the same day (SDD group), 24 (37%) on postoperative day (POD) 1, 16 (25%) on POD 2/3, and 3 (5%) stayed $4 days. One patient in the SDD group was readmitted on POD 3 after EVAR for severe postimplantation syndrome. Of the 23 patients who were discharged on POD 1, 10 were kept overnight due to severe chronic obstructive pulmonary disease, coronary artery disease, or advanced age, three transportation issues, two inability to void, two patient preference, two for renal protection, and four due to unplanned femoral cutdown. Patients in the SDD group were significantly younger (66.5 6 5.4 years vs 72.0 6 10.6 years; P [ .029), had smaller AAAs (5.3 6 0.5 cm vs 5.9 6 1.0 cm; P [ .013), less blood loss (115 6 90 mL vs 232 6 198 mL; P [ .012), and shorter operating time (79 6 24 minutes vs 121 6 73 minutes; P [ .013). There were fewer American Society of Anesthesiologists 4 patients in the SDD group (24% vs 48%; P [ .056). The majority (81%) of patients in all groups had general anesthesia (86% vs 79% SDD vs others; P [ .523). Conclusions: Ambulatory PEVAR was found to be feasible and safe in one-third of patients undergoing elective EVAR who did not have excessive medical risk, had good functional capacity, and underwent an uneventful procedure. The impact of SDD on cost-effectiveness needs to be further assessed and may not be feasible in hospitals reimbursed based on admission status. (J Vasc Surg 2014;59:58-64.)
Endovascular abdominal aortic aneurysm repair (EVAR) is associated with decreased perioperative mortality and
From the Division of Vascular Surgery, Veterans Affairs Western New York Healthcare System, Buffaloa; Division of Vascular Surgery, Department of Surgery, State University of New York at Buffalo, Buffalob; and the Division of Vascular Surgery, South West Regional Health Authority, San Fernando.c This material is the result of work supported with the resources and the use of facilities at the Veterans Affairs Western New York Healthcare System. The contents of this paper do not represent the views of the Department of Veterans Affairs or the United States Government. Author conflict of interest: none. Presented at the Forty-first Annual Symposium of the Society for Clinical Vascular Surgery, Miami, Fla, March 12-16, 2013. Reprint requests: Hasan H. Dosluoglu, MD, Division of Vascular Surgery, Veterans Affairs Western New York Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214/$36.00 Copyright Ó 2014 by the Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jvs.2013.06.076
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morbidity, blood loss, and length of stay (LOS) compared with open aneurysm repairs in randomized and nonrandomized trials.1-3 In addition, EVAR has comparable long-term outcomes,4 even in those with challenging anatomy.5 In an effort to further decrease morbidity, percutaneous EVAR (PEVAR) has been introduced using a variety of closure devices and has been reported to have fewer groin wound complications, decreased operation times, and time to ambulation.6 However, impact on LOS has been modest, with a mean of 3.5 days in open access compared to 2.7 days in those who had PEVAR in studies comparing both approaches.7-9 The overall cost of EVAR has been reported to be higher than open repair mainly due to device costs, surveillance imaging and reinterventions10,11; however, the cost analysis of the Open vs Endovascular Repair (OVER) trial reported that in-hospital costs were lower with EVAR persisting up to 2 years.12 Since device costs are somewhat fixed, decreasing intensive care and overall hospital LOS and wound complications would further decrease the cost of EVAR. Al-Zuhir et al13 reported that by implementing a protocol of identifying patients for short-stay EVAR, about
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27% of patients could be discharged on the first postoperative day (POD), resulting in significant cost reduction. We started using PEVAR in 2005 with the double Proglide technique and observed that all closure failures were identified and addressed in the operating room (OR), and emergency reintervention after surgery was not required in any patient.14 We also observed that patients who develop moderate to severe postimplantation syndrome (PIS) have extended LOS despite needing only supportive care, as reported by others.15 Consequently, we started offering same-day discharge (SDD) after PEVAR beginning in March 2011. The goal of this study was to assess the feasibility and safety of ambulatory PEVAR in selected patients and identify the characteristics of these patients. METHODS Design and methodology. All patients who underwent EVAR in the Veterans Affairs Western New York Healthcare System between March 1, 2011 and December 31, 2012 were identified from our prospectively maintained database, and the data were retrospectively analyzed. Demographics, comorbidities, clinical presentation, aneurysm characteristics (size, neck diameter, neck length, characteristics [shape, calcification, clot], tortuosity, iliac diameter), operative details, postoperative course, intensive care unit (ICU) and overall LOS, and follow-up clinical and imaging data were recorded. Comparisons were made between those who were discharged on the day of EVAR (SDD), POD 1, and later. Patients who had uneventful EVAR with no type I or III endoleaks had one postoperative clinic visit 2 weeks after surgery, computerized tomography (CT) imaging with contrast at 6 months, and the every 12 months imaging with either ultrasonography or CT without contrast if they had no endoleak or sac expansion. Patients with endoleak or sac expansions were monitored with CT every 6 months. CT imaging and clinical examination were used to assess the femoral arteries. EVAR procedures. Planning and graft selection was performed by vascular surgeons based on anatomic characteristics of the abdominal aortic aneurysm (AAA). Four Food and Drug Administration-approved devices were used during the study period (Zenith; Cook Inc, Bloomington, Ind; Excluder; Gore Inc, Newark, Del; AFX; Endologix Inc, Irvine, Calif; and Endurant; Medtronic Inc, Minneapolis, Minn). Percutaneous EVAR was planned except in those who needed femoral endarterectomy (FEA) for bulky occlusive disease, femoral aneurysm repair, or excessive calcification of the anterior femoral artery wall. Femoral access was obtained with micropuncture, and access angiogram was obtained via microcatheter before dilating the tract. Most recently, ultrasound-guided access was used to optimize initial puncture site selection. Preclose/double Proglides (Abbott, Inc, Abbott Park, Ill) technique was used,14 with the modification of minimal angulation of the Proglides (10 ). After EVAR completion, the sutures were tied, starting from the larger access site. If there was continued oozing after the second Proglide was
Dosluoglu et al 59
tied, and bleeding was controlled by reinsertion of a 6 to 7F sheath, a third Proglide was placed. In patients without adequate hemostasis, a small cutdown was made after large sheath reinsertion, and fascial closure was achieved using 3/0 prolene.16 The femoral artery was fully dissected and repaired only if fascial closure failed. General anesthesia was preferentially used except for those deemed excessively high risk, in whom local anesthesia with sedation was used. The EVAR procedures were performed in standard fashion as recommended by the instructions for use for each of the grafts. Patients received 80 U/kg of intravenous heparin after femoral arteries were accessed, and heparin was reversed using 20- to 30-mg protamine after confirming no change in pedal pulses. Approach. Our first patient in this series was offered discharge without prior planning or discussion, as he appeared very comfortable postoperatively. However, after the initial favorable experience, we started discussing the option of SDD for patients with favorable anatomy, good renal function with no plans for intravenous hydration postoperatively, those who were not medically high risk, had good functional capacity, lived independently, and had someone to stay with them the night of surgery. Medically high risk included severe chronic obstructive pulmonary disease (COPD) on home oxygen, congestive heart failure, or advanced age (>80 years). Patients who lived more than 50 miles from the hospital or in a rural setting were not considered for discharge, as we do not have access to a closer monitored accommodation setup. We also scheduled SDD PEVAR procedures before noon to allow time for observation. SDD was again discussed in preoperative holding, and pedal pulses were checked for verification of baseline status. Patients were informed that they could be discharged if we had no concerns regarding the repair (satisfactory, uneventful placement of endograft, good hemostasis, no intraoperative events), closure or medical condition. A Foley catheter was placed in all patients and removed in the OR after procedure completion. Patients were observed in the postanesthesia care unit for 2 hours and were then either transferred to floor to be discharged later, or, in the latter part of the study, directly to the ambulatory surgery unit, decreasing paperwork associated with admission and discharge. Patients were discharged if they could ambulate without difficulty and voided. In addition to routine instructions, patients were advised to take acetaminophen if they developed a low-grade fever, or mild back pain, and to hydrate as much as possible. Definitions. Functional capacity was considered to be poor if the patient’s exercise tolerance was estimated to be <4 metabolic equivalents during their preoperative evaluation, as described by the Duke Activity Status Index17 and the American Heart Association exercise index.18 PIS was defined as any combination of the following: fever >100 F, white blood cell count >10,000/mm3, abdominal and/or back pain, or other nonspecific symptoms such as malaise or loss of appetite. Renal insufficiency was defined as an estimated glomerular filtration rate <60 mL/min/ 1.73 m2. The definitions in the reporting standards by the
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Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/ American Association for Vascular Surgery19 were used for endoleak, technical success, and other aneurysm-related events. Statistical analysis. Data analysis was performed using SPSS 18.0 software (SPSS Inc, Chicago, Ill). Continuous variables are given as mean 6 standard deviation. Demographic comparisons were made using c2 test for categorical variables, and by t-test for continuous variables. All P values were considered significant if <.05. The study was approved by the Institutional Review Board for Research at the Buffalo Veterans Affairs, and informed consent was waived due to the retrospective nature of the study. RESULTS A total of 79 male patients underwent AAA repair. The study population included 64 patients, as 15 were excluded (three ruptures [two open, one EVAR], five acute presentations [all EVAR], three fenestrated EVARs, and four elective open repairs). In the study group (n ¼ 64), one patient had blue toe syndrome, and four patients had disabling claudication due to their iliac occlusive disease and had AAA repair in combination with intervention for their occlusive iliac disease. The remaining 59 patients had no aneurysm-related or unrelated symptoms. Mean AAA diameter was 5.7 6 0.9 cm (range, 4.0-10.0 cm). Demographics, comorbidities, and anatomic characteristics are listed in Tables I and II. Overall, 54 (84%) had bilateral percutaneous attempts, seven (11%) had unilateral percutaneous attempts (six FEA/patch, one had planned femoral cutdown for access due to calcification), and three (5%) patients had bilateral femoral cutdowns (two had FEA/patch, one cutdown to prevent emboli). The success rate for PEVAR was 96% (100% for 9-16F, 93% for 17-22F sheaths) for attempted closures, and 94% for 54 patients in whom bilateral PEVAR was attempted. All four conversions occurred in patients with bilateral PEVAR attempts (two in 17F and two in 22F sheaths). One conversion occurred because of the inability to deploy the closure device due to vessel calcification. The remaining three patients had inadequate hemostasis after device deployment. Two were managed with femoral fascial closures, and one needed a femoral patch. Overall, 81% of the procedures were performed under general anesthesia, while 19% had local anesthesia with moderate sedation. The grafts used were Zenith (Cook Inc) in 16 (25%), Excluder (Gore Inc) in 17 (27%), AFX (Endologix Inc) in 21 (33%), and Endurant (Medtronic Inc) in 10 (16%). A total of 35 adjunctive procedures were used in 18 (28%) patients, three of whom were in the SDD group (Table III). None of the patients in this cohort needed blood transfusion, and the operative details are listed in Table II. Twenty-one (33%) patients were discharged on the same day, 23 (36%) were discharged on POD 1 (10 [16%] with 23-hour observation status, 13 [20%] as full admit), 17
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(27%) were discharged on POD 2/3 (11 on POD 2, 6 on POD 3), and the remaining three (5%) were discharged between POD 4 to 6. The mean LOS was 1.3 6 1.4 days (median 1 day), and mean ICU stay was 0.1 6 0.4 days (five stayed 1 day, two stayed 2 days). The mean LOS in patients treated percutaneously was 1.0 6 1.1 days. There was no 30-day mortality. Postoperative complications were observed in 11 (17%) patients (Table IV). There was one hematoma in the PEVAR-treated patients in the SDD group, which resolved spontaneously. The reasons for the 23 patients in the POD 1 discharge group to stay overnight, rather than being discharged on the same day, were poor medical condition in 10 (severe COPD with home O2 in 5, ischemic cardiomyopathy in 2, advanced age in 3), transportation issues in three (two lived >100 miles away, one had no transportation), patient preference in one, inability to void in two, poor renal function necessitating intravenous hydration and urine output monitoring in two, and femoral cutdown in four. PIS occurred in 15 patients (23%), four in the SDD group (19%), and 11 in the non-SDD groups (26%). In the SDD group, this was reported to have occurred by patients during postoperative clinic visits, without objective testing. The incidence was 31% in patients who had Zenith (Cook Inc), 12% in Excluder (Gore Inc), 10% in AFX (Endologix Inc), and 60% in Endurant (Medtronic Inc) grafts (P ¼ .009). The only unplanned readmission occurred in the SDD group because of severe PIS on POD 3. The patient presented with back pain, increased white blood cell count (14,000/mm3), and fever (100 F). He was medically managed with hydration, pain control, and anti-inflammatory medications and was discharged after 3 days. Of the 11 patients in the nonSDD group with PIS, 3 were discharged on POD 1, 5 were discharged on POD 2, and 3 were discharged on POD 3. PIS was the only reason for delayed discharge in five patients, three of whom were discharged on POD 2, and two on POD 3. The demographic characteristics, comorbidities, anatomic features and operative details of patients in the SDD group, POD 1 group and POD $ 2 group are compared in Tables I and II. Patients in the SDD group were significantly younger (66.5 6 5.4 years vs 72.0 6 10.6 years; P ¼ .029), had smaller AAAs (5.3 6 0.5 cm vs 5.9 6 1.0 cm; P ¼ .013), less blood loss (115 6 90 mL vs 232 6 198 mL; P ¼ .012), and required shorter operating time (79 6 24 minutes vs 121 6 73 minutes; P ¼ .013). There were fewer American Society of Anesthesiologists class 4 patients in the SDD group (24% vs 48%; P ¼ .056) and fewer on home O2 than patients discharged on POD 1 (5% vs 30%; P ¼ .027). All patients in the SDD group had successful total PEVAR. The mean follow-up after the index procedure was 8.3 6 6.6 (range, 1-24) months. There were no aneurysm-related mortalities. Four patients died (three in POD 1, one in POD 2 groups), three from cancer at 3, 6, and 13 months, and one from multiple system organ
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Table I. Demographics and comorbidities of patients
Age, years CAD CHF Hypertension DM CVD Hyperlipidemia COPD Home O2 Active smoker Renal (eGFR <60) ASA class 4 Beta-blocker Statin ACEI ECASA Clopidogrel Warfarin
Overall (n ¼ 64)
SDD (n ¼ 21)
POD 1 (n ¼ 23)
POD $ 2 (n ¼ 20)
70.2 6 9.9 (59-97) 50 11 75 23 15 91 45 17 46 22 39 59 72 55 86 9 19
66.5 6 5.4 (59-79) 48 10 86 24 14 95 33 5 35 14 24 57 57 71 95 5 10
71.0 6 9.0 (61-87) 52 9 78 26 17 91 57 30 50 17 48 65 83 43 91 0 22
73.1 6 12.4 (59-97) 50 15 60 20 11 85 45 15 53 35 50 55 75 50 70 25 25
P .029a .955 .779 .148 .894 .851 .526 .304 .027b .405 .224 .056a .768 .160 .156 .044c .013c .402
ACEI, Angiotensin-converting enzyme inhibitor; ASA, American Society of Anesthesiologists; CAD, coronary artery disease; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CVD, cerebrovascular disease; DM, diabetes mellitus; ECASA, enteric-coated acetylsalicylic acid; eGFR, estimated glomerular filtration rate; POD, postoperative day; SDD, same-day discharge. Continuous data are presented as mean 6 standard deviation (range) and categoric data as percentage. a SDD vs other groups. b SDD vs POD 1. c POD $ 2 vs other groups.
Table II. Aneurysm characteristics and operative details in groups
AAA diameter Neck diameter Neck length High-risk neck Adjuncts, no FEA Adjuncts, FEA EBL, mL Transfusion OR time, minutes Total percutaneous. Unilateral percutaneous Bilateral cutdown General anesthesia
Overall (n ¼ 64)
SDD (n ¼ 21)
POD 1 (n ¼ 23)
POD $ 2 (n ¼ 20)
5.7 6 0.9 (4.0-10.0) 25.4 6 3.7 (18-34) 24.0 6 10.6 (5-50) 23 17 28 194 6 178 (20-1000) 0 107 6 64
5.3 6 0.5 (4.0-6.5) 25.0 6 2.6 (19-30) 26.2 6 11.4 (8-40) 19 14 14 115 6 90 (20-300) 0 79 6 24 (50-132) 100 0 0 86
5.8 6 0.6 (4.0-7.2) 25.1 6 3.8 (21-34) 21.7 6 10.4 (5-50) 35 22 26 196 6 118 (50-500) 0 99 6 50 (52-265) 74 22 4 78
6.1 6 1.3 (4.5-10.0) 23.9 6 5.3 (18-33) 24.2 6 9.7 (12-40) 15 15 45 275 6 259 (25-1000) 0 147 6 88 (55-341) 60 30 10 80
84 11 5 81
P <.02a NS NS .263 .769 .031b <.015a <.04b .016a .05a .316 .806
AAA, Abdominal aortic aneurysm; EBL, estimated blood loss; FEA, femoral endarterectomy; NS, not significant; OR, operating room; POD, postoperative day; SDD, same-day discharge. Continuous data are presented as mean 6 standard deviation (range) and categoric data as percentage. a SDD vs others. b POD $ 2 vs SDD.
failure at 15 months. There were no type I or III endoleaks, but four type II endoleaks persisting after 6 months, three of whom had 2- to 4-mm sac diameter increase and are being monitored. One patient presented with left leg
embolization and had Fogarty thrombectomy followed by relining of iliac limb with stent graft. One patient started dialysis at 15 months (baseline estimated glomerular filtration rate 17 mL/min/1.73 m2).
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Table III. Adjuncts used during endovascular AAA repair in 18 patients Aneurysm related Proximal cuff IIA coil embolization Bell-bottom iliac >20 mm IIA ostium coverage Sac embolization EIA stent Renal stent Access related Transbrachial access FEA EIA-IIA bypass
5 4a 1 2 2 3 7b 1 9 1
AAA, Abdominal aortic aneurysm; EIA, external iliac artery; FEA, femoral endarterectomy; IIA, internal iliac artery; SDD, same day discharge. a One patient in the SDD group. b Two patients in the SDD group.
Table IV. Postoperative complications Buttock claudication Hematoma Urinary retention Inguinal neuritis Prolonged ileus Arrhythmia Hematuria CHF exacerbation, reintubation PIS
1 1 4 1 1 1 1 1 15
(2) (2) (6) (2) (2) (2) (2) (2) (23)
CHF, Congestive heart failure; PIS, postimplantation syndrome. Data are presented as number (%).
DISCUSSION Our study showed that about one-third of patients who undergo EVAR can be safely discharged home after a 6-hour observation period, despite the use of general anesthesia in the majority of patients. This is the first report on ambulatory PEVAR, with the shortest reported mean LOS in a consecutive patient series. With more widespread PEVAR and decreased device profiles of available EVAR devices, this approach is likely to become more attractive. PEVAR has been increasing since its introduction in the late 1990s.20 In the National Surgical Quality Improvement Program database, 44% of 6009 patients who underwent elective EVAR between 2005 and 2008 were treated percutaneously.21 The Preclose/double Proglide technique was first reported in 2007 and is the technique we utilize.14,22 The advantages of Proglide include its lower cost and nonbraided suture. There is a steep learning curve to PEVAR,23,24 and ambulatory PEVAR should not be considered by surgeons still on the learning curve of PEVAR. The advantage of PEVAR over femoral cutdown includes fewer groin wound complications, decreased operative time, and decreased time to ambulation.6 In a systematic review of 22 papers involving 1087 patients (1751 groins), overall success was 92%, decreasing with an increase in sheath size.6 Operative time was shorter (106 vs 145 minutes, weighted mean) in PEVAR than open
exposure with five of eight studies reporting significant differences. Time to ambulation was also shorter in PEVAR, with 81% of patients ambulating within 6 hours in one study.25 Hospital stay was also decreased in PEVAR with a mean of 2.07 days. However, the cost of PEVAR was similar between groups, as the device costs were not adequately compensated by decreased procedural time in these series. None of these studies, however, has explored the effect of reduced hospital stay on overall cost. In more recent series, the mean LOS has been reported to be between 1.4 to 3.1 days.26,27 We report the shortest mean LOS for PEVAR with 1.0 6 1.1 days. PEVAR is likely to reduce readmission rates. Similar to open AAA repair, the most common reason for readmission after both EVAR/PEVAR was wound complications in a 5% random sample of Medicare beneficiaries (1502 patients) between 2004 and 2006.28 The only readmission observed in our SDD cohort occurred from severe PIS in one patient 3 days after discharge. Arnaoutoglou et al reported readmission for severe PIS within 30 days in six out of 162 patients, two of whom needed ICU admission for medical management.15 PIS was noted to be less frequent in our patients who had polytetrafluoroethylene-based grafts (10%-12%) than Dacron grafts (31%-60%). This association has been reported by others and is likely valid.29,30 Although PIS is generally inconsequential, it frequently delays discharge and increases cost in hospitalized patients. PIS was the cause for further delay in discharge in five of our hospitalized patients, two of whom stayed until POD 3. We have found the best way to avoid unnecessary discharge delays is to discharge patients home on the day of surgery with instructions for acetaminophen or ibuprofen and oral hydration. Few patients are likely to need readmission due to severe PIS. Anesthetic technique has been suggested to have an impact on postoperative morbidity and LOS. In an analysis of 6009 patients who underwent EVAR between 2005 and 2008, general anesthesia was associated with increased pulmonary morbidity and LOS compared with spinal or local anesthesia.21 Of note, 46% and 40% of the patients in general and local anesthesia had the procedures performed percutaneously, whereas these were 38% and 28% in the spinal and epidural anesthesia groups, respectively. In a review of 10 studies involving 13,459 patients comparing local anesthesia with general anesthesia, patients who had local anesthesia had shorter operative times, shorter LOS, and fewer postoperative complications, although percutaneous procedures were found to be performed more frequently under general anesthesia.31 In our series, local anesthesia was the preferred approach for high-risk patients, especially those with severe COPD. The vast majority (86%) of SDD patients had general anesthesia, which was similar in all groups. Although local anesthesia with sedation is feasible, inability to reliably suspend breathing during graft deployment, and some patient discomfort during sheath manipulation or relative limb ischemia, leads to our preference for general anesthesia. This has not impacted LOS, similar to patients having minimally invasive laparoscopic procedures
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with SDD.32 Thus, it seems that the invasiveness of the procedure, rather than the type of anesthesia, determines suitability for SDD. One potential concern of sending patients home on the same day is life-threatening bleeding or limb ischemia after discharge. In our experience, all percutanous failures occurred in the OR, with no patient returning to the OR in the early or late postoperative period, similar to previous reports.7,22 In the large series by Lee et al,22 15 of the 16 early failures occurred intraoperatively, with one patient requiring late (POD 27) repair from a necrotizing groin infection. In Borner et al’s series,33 15 of 17 failures were addressed in the OR, and two returned for bleeding within 24 hours. The authors suggest that these two failures occurred early in their series, did not have adequate hemostasis, and in retrospect, should have been repaired intraoperatively. We cannot emphasize enough that hemostasis and pedal perfusion should be completely satisfactory before consideration for SDD. Therefore, performing these procedures in an outpatient center setting would be challenging since the adequacy of hemostasis and distal perfusion cannot be guaranteed prior to procedure completion, even by those with extensive experience. Device cost is the main component driving overall cost of EVAR. The associated decreased duration of surgery, ICU and overall LOS, decreased blood product usage, and laboratory tests have been proposed to not adequately counteract these costs, especially in early studies.11,12 Since device costs are outside of surgeons’ control, decreasing LOS remains the main component on which cost decrease can be accomplished. In the study by Al-Zuhir et al,13 increase in short-stay EVAR cases from 30% to 45% in the first and second half of the study resulted in a decrease in overall costs of approximately £2,000. In the OVER trial, the hospital cost was $5900 less in the EVAR group, despite a mean LOS of 5.0 days, which was significantly less than open (10.5 days; P < .001).12 Even with surveillance studies and reinterventions, EVAR remained less costly during follow-up in the OVER trial and in a costeffectiveness analysis by Hayes et al.34 The decreased frequency of postoperative surveillance and ultrasoundbased surveillance adopted by many centers will likely result in increased cost-efficiency of EVAR over open AAA repair.35,36 The current study was conducted in the Veterans Affairs System, and the hospital reimbursement for these procedures was not affected by patients’ ambulatory status. This may not be applicable to the private sector, currently, and would potentially result in a financial loss, as hospitals may not be reimbursed for outpatient devices with outpatient EVAR procedures. Until Centers for Medicare and Medicaid Services allows coding for these devices in an outpatient setting, ambulatory PEVAR will not be feasible in private sector hospitals. We believe that SDD may be feasible in about 40% of EVAR cases if transportation and home issues are resolved preoperatively. The remaining 60% patients are unlikely to be candidates for SDD, as their factors for hospitalization
Dosluoglu et al 63
are not modifiable, or in some cases, unpredictable, such as inability to void after the procedure.13 Although identification of high-risk patients for failure to void could potentially help for planning of discharge, this would likely not have a significant impact on overall LOS. The limitations of our study include its retrospective nature and lack of a strict protocol for a relatively small number of patients undergoing EVAR for the selection of ambulatory PEVAR. However, patients were approached in a uniform fashion, and our results are easily reproducible in centers with experience in PEVAR procedures. We also did not study the cost savings; however, it is hard to dismiss the potential savings associated with decreased LOS and decreased laboratory tests. Our approach did help our hospital by decreasing bed requirements, as inpatient beds are scarce, not infrequently resulting in patients waiting admission in the emergency room, or being diverted. CONCLUSIONS In this study, we found that ambulatory PEVAR is feasible and safe in one-third of patients undergoing elective EVAR, who do not have excessive medical risk, have good functional capacity, and have undergone an uneventful procedure. Its impact on cost-effectiveness needs to be further assessed and may not be applicable currently in non-VA hospitals. AUTHOR CONTRIBUTIONS Conception and design: HD, PL Analysis and interpretation: HD, PL, RB, LH, MD Data collection: HD Writing the article: HD Critical revision of the article: HD, PL, RB, LH, MD Final approval of the article: HD, PL, RB, LH, MD Statistical analysis: HD Obtained funding: Not applicable Overall responsibility: HD REFERENCES 1. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, et al; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009;302:1535-42. 2. EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet 2005;365:2179-86. 3. Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, et al. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg 1999;29:292-305. 4. Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, et al; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med 2012;367:1988-97. 5. Turnbull IC, Criado FJ, Sanchez L, Sadek M, Malik R, Ellozy SH, et al. Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg 2010;51:537-44.
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Submitted Apr 30, 2013; accepted Jun 26, 2013.