Utility and reliability of endovascular aortouniiliac with femorofemoral crossover graft for aortoiliac aneurysmal disease

Utility and reliability of endovascular aortouniiliac with femorofemoral crossover graft for aortoiliac aneurysmal disease Thomas F. Rehring, MD,a David C. Brewster, MD,a Richard P. Cambria, MD,a John A. Kaufman,b MD, Stuart C. Geller, MD,b Chieh-Min Fan, MD,b Jonathan P. Gertler, MD,a Glenn M. LaMuraglia, MD,a and William M. Abbott, MD,a Boston, Mass Objective: The purpose of this study was to determine the early efficacy of endovascular aortouniiliac stent grafts with femorofemoral bypass graft in the treatment of aortoiliac aneurysmal disease. Methods: We analyzed 51 consecutive patients from January 1997 to March 1999 with a mean follow-up of 15.8 months. Patients ranged in age from 44 to 93 years (mean, 75 years) with a mean aortic aneurysm diameter of 6.2 cm. Technical success was achieved in 50 patients; one patient required conversion to open repair intraoperatively. We placed 28 custom-made and 22 commercial devices. The mean operative time was 223 minutes. The endograft was extended to the external iliac artery in 42% of cases. The contralateral common iliac artery was occluded using either a closed covered stent or intraluminal coils. Results: The median hospital stay was 4 days with an average intensive care unit stay of 0.25 days. There were no operative mortalities. Two patients died during follow-up from unrelated conditions. Endoleaks occurred in 11 patients (22%); seven patients (14%) required intervention (four catheter based, three operative). Other complications occurred in 38% of patients but were largely remote or wound related. One femorofemoral bypass graft occluded immediately postoperatively as a result of an intraprocedural external iliac dissection yielding a 98% primary patency and 100% secondary patency. Clinical success was achieved in 88% of patients. Conclusions: These data suggest that this strategy represents a reliable method of repair of aortoiliac aneurysmal disease and extends the capability of an endoluminal approach to patients with complex iliac anatomy. (J Vasc Surg 2000;31:1135-41.)

Transfemoral endovascular repair of abdominal aortic aneurysms (AAAs) has proven feasibility and considerable benefits over traditional open repair.1-3 However, strict anatomic requirements have limited the application of this method of therapy. Indeed,

From the Division of Vascular Surgerya and Section of Vascular Radiology,b Massachusetts General Hospital and Departments of Surgery and Radiology, Harvard Medical School. Competition of interest: nil. Presented at the Twenty-sixth Annual Meeting of the New England Society for Vascular Surgery, Chatham, Mass, Oct 1-3, 1999. Reprint requests: David C. Brewster, MD, One Hawthorne Place, Suite 111, Boston, MA 02114. Copyright © 2000 by The Society for Vascular Surgery and International Society for Cardiovascular Surgery, North American Chapter. 0741-5214/2000/$12.00 + 0 24/6/107120 doi:10.1067/mva.2000.107120

several recent studies suggest that only 10% to 20% of all AAAs are treatable with currently available commercial devices.4-6 Although inadequate proximal aortic neck length and diameter are generally thought to be the main limitations in endograft placement, adverse iliac anatomy precludes placement in as many as 50% of patients.5 The use of an aortouniiliac endoprosthesis in combination with a femorofemoral crossover graft would permit an endovascular approach to the broadest array of patients as only one iliac system is required to satisfy anatomic criteria (Fig 1, A). However, enthusiasm for this type of reconstruction has been restrained by apprehension regarding the durability of the femorofemoral bypass graft and the potential for late complications such as graft infection or pseudoaneurysm formation. Furthermore, the consequences of exclusion of one or both internal iliac arteries 1135

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B

A

C

Fig 1. A, Schematic depicting aortouniiliac endograft with contralateral common iliac exclusion and femorofemoral bypass graft. B, Standard intraoperative completion angiogram of aortouniiliac endograft. C, Angiogram demonstrating femorofemoral graft with retrograde filling of external and internal iliac arteries contralateral to the aortouniiliac endograft.

Table I. Patient comorbidity Characteristic Hypertension Current tobacco use Diabetes mellitus COPD Cardiac disease Congestive heart failure Creatinine level > 1.6 mg/dL Peripheral vascular disease

No. of patients (%) 34 13 5 15 31 9 5 19

(68) (26) (10) (30) (62) (18) (10) (38)

COPD, Chronic obstructive pulmonary disease.

occasionally required by this repair may be significant. Therefore, the purpose of this study was to analyze the results of endovascular aortouniiliac bypass graft with concomitant femorofemoral bypass graft in patients with aortoiliac aneurysmal disease. METHODS From January 1997 to March 1999 we analyzed 51 consecutive patients undergoing transfemoral endovascular aortouniiliac graft with femorofemoral bypass graft and contralateral iliac occlusion for aor-

toiliac aneurysmal disease. All patients underwent contrast-enhanced spiral computed tomography (CT) with 3.0-mm cuts. Subsequently, all patients had biplanar contrast angiography with radiopaquemeasuring catheters to allow precise measurements for the endoprosthesis. Anatomic selection criteria used for endovascular repair have been previously described from our institution.1 In general, the criteria for aortouniiliac grafts are somewhat more lenient, because only one suitable iliac artery is required to meet anatomic criteria. For this study, we required one distal common iliac artery or external iliac artery to have an appropriate attachment site of 1.5 cm in length and 14 mm or less in diameter. In cases requiring extension of the aortouniiliac endograft to the external iliac artery level, the internal iliac artery ipsilateral to the planned aortouniiliac graft was occluded with coil embolization preoperatively. The protocol for endovascular repair of AAA was approved by the institutional review board of the Massachusetts General Hospital. All procedures were performed in an operating room environment by a team of vascular surgeons and interventional radiologists. The choice of anes-

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Table II. Life table analysis of cumulative patency Patent, but withdrawn because of

Time 0 1 3 6 9 12 15 18 21 24 27 30 33

No. at risk 50 47 43 39 34 29 24 18 13 9 5 3 1

No. failed 0 1 0 0 0 0 0 0 0 0 0 0 0

Duration 3 3 2 3 5 4 6 5 4 4 2 2 3

Lost 0 0 2 1 0 0 0 0 0 0 0 0 0

thetic was made by the anesthetist in consultation with the vascular surgeon. Accurate endograft deployment and positioning, as well as the absence of endoleaks, were confirmed by intraoperative aortography (Fig 1). All patients had a plain abdominal radiograph and a contrast enhanced CT scan of the abdomen on the first postoperative day to establish a baseline study, confirm placement, and evaluate for endoleaks. Physical examination, abdominal radiography, and CT scans were obtained at 6 months, 12 months, and once a year thereafter. Complications were recorded as both local/vascular and systemic/remote, as suggested by the Ad Hoc Committee for Standardizing Reporting Practices in Vascular Surgery of the Society for Vascular Surgery and International Society for Cardiovascular Surgery.7 If two or more complications occurred in the same patient, only the most significant complication was recorded to avoid duplication. Where applicable, nominal data are presented as mean ± SE of the mean. RESULTS The average patient in this study was male (94%) and was aged 75.2 ± 1.2 years (range, 44-93 years). The mean aortic aneurysm diameter was 6.2 cm. As shown in Table I, patients in the study had a standard comorbidity for those undergoing vascular interventions. Technical success was achieved in 50 patients; one patient required conversion to open repair intraoperatively. Of these, 22 patients received a commercial device (EVT-Guidant; Menlo Park, Calif) as part of a United States Food and Drug Administration Phase I and II trial. The remaining patients received an endograft custom-made at our

Death 0 0 0 1 0 1 0 0 0 0 0 0 0

Total withdrawn 3 3 4 5 5 5 6 5 4 4 2 2 3

Interval patency 1.00 0.98 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00 1.00

Cumulative patency 100 97.8 97.8 97.8 97.8 97.8 97.8 97.8 97.8 97.8 97.8 97.8 97.8

SE 0 0.31 0.34 0.37 0.43 0.50 0.60 0.81 1.12 1.61 2.90 4.83 14.50

institution of Gianturco stents and standard vascular graft material, as previously described.1 A combination of continuous lumbar epidural with general anesthesia was used in 28 patients (56%). Eighteen patients underwent general anesthesia alone, and four procedures were performed under epidural only. The mean operative time was 223 ± 8 minutes. The mean estimated blood loss was 631 ± 62 mL. The aortoiliac graft was carried to the external iliac artery in 42% of cases. The contralateral iliac artery was occluded with a mean of 20 ± 2 coils in 36 patients. The remaining arteries were occluded with a commercial, closed, covered stent (EVT-Guidant). In six patients (12%), both internal iliac arteries were excluded. The femorofemoral bypass graft was created with 8- or 10-mm diameter grafts of Dacron (22) or polytetrafluoroethylene (28) at the surgeons’ discretion. The median inpatient hospital stay was 4.0 ± 1.2 days. Most patients (87.5%) were transferred directly to the hospital floor after a 4- to 6-hour stay in a standard postoperative recovery room. Half of all patients were discharged without anticoagulation. Aspirin was administered to 21 patients (43%). Three patients (7%) taking warfarin for preoperative conditions had it resumed upon discharge. The mean follow-up was 15.8 months (range, 2.2-33 months) (Table II). There were no perioperative deaths. Two patients died during follow-up from unrelated conditions. Other complications occurred in 38% of patients but were largely remote or wound related (Table III). One groin wound hematoma was seen that required operative drainage. Three patients had groin wound infections; one required complicated skin flap closure.

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Fig 2. Endograft stenosis. A, Intraoperative angiogram showing stenosis of aortouniiliac endograft resulting from a twist in redundant graft material distal to radiopaque marker (arrow) and proximal to stent attachment site (curved arrow). B, Resolution of stenosis with secondary Wallstent deployment.

Two intraoperative arterial injuries were noted that required immediate repair. Device kinking or stenosis that necessitated intervention occurred in four patients (Fig 2). One stenosis resulted in aortoiliac graft occlusion requiring lytic therapy and stent placement. The remaining patients were treated with secondary endovascular procedures (angioplasty and stent placement). All of these occurred in the body of an unsupported endograft. One femorofemoral bypass graft occluded immediately postoperatively as a result of unrecognized intraprocedural external iliac dissection. This required placement of an iliofemoral interposition graft through a secondary procedure, thus yielding a 98% primary patency and 100% secondary patency of the femorofemoral bypass graft. Table II depicts a life table analysis of cumulative (primary) patency. Ischemic colitis was suspected on colonoscopy in one patient with postoperative abdominal pain and diarrhea. This patient responded to conservative therapy. Both internal iliac arteries were excluded in that patient. Pain or discomfort in the hip and buttock area related to exercise and suggestive of buttock claudication was noted in 22% of patients in the first few postoperative weeks. This complication generally improved over 2 to 3 months but persisted for the duration of the follow-up interval in six patients (12%). Three of these patients had one internal iliac artery preserved at the time of their endograft placement.

Systemic complications (Table III) were remarkable for three patients with acute renal failure. One of these patients required temporary dialysis while hospitalized. Ninety percent of all patients in the study had a baseline creatinine level of 1.6 mg/dL. All patients with postoperative elevations in creatinine levels had a baseline creatinine level of 1.5 mg/dL. No patient required permanent dialysis. Endoleaks occurred in 11 patients (22%); seven of these patients (14%) required intervention (four catheter based, three operative). Type I endoleaks occurred in 5 patients, 3 at the proximal attachment site and 2 at the distal attachment site. Three of the five required intervention. One of these patients required open aortoiliac grafting for a persistent leak with a contrast–filled, symptomatic aneurysm. The other two were treated with coil embolization of the sac. Two small Type I endoleaks sealed without intervention in the initial 6 months after insertion. Type II endoleaks were seen in six patients. Four of these required intervention, two catheter based and two open. Catheter-based interventions included coil embolization of an enlarging aneurysm sac for a lumbar-to-lumbar leak and coil embolization of a persistent leak from a patent inferior mesenteric artery. Of the open procedures, one patient underwent late conversion to open graft repair for a large persistent branch-to-branch leak and enlargement of the aneurysm sac 4 months after endograft place-

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Table III. Complications in patients with aortouniiliac/femorofemoral bypass grafts Complication Local or vascular Graft kinking/stenosis Wound infection Arterial injury Graft thrombosis Buttock claudication Hematoma Ischemic colitis Systemic or remote Acute renal failure (transient) Bacteremia Myocardial infarction Urinary tract infection

Table IV. Reported patencies of isolated femorofemoral bypass grafts

No. of patients (%) 14 3 3 2 2 1 1 1 6 3 1 1 1

(28) (6) (6) (4) (4) (2) (2) (2) (12) (6) (2) (2) (2)

ment. The second patient required open ligation of a contralateral external iliac artery to correct continued retrograde filling of a common iliac aneurysm after failure to thrombose it with intraluminal coils. This was the only leak directly related to the failure of a contralateral iliac artery with coils. No failure was noted from the commercial occluder. Clinical failures (graft endoleaks persisting > 6 months or aneurysm sac enlargement) occurred in six patients (12%).7 No new late onset endoleaks were noted. No late ruptures were seen. No evidence for stent migration was found. Aneurysm sac shrinkage averaged 1.2 cm over a mean CT interval of 15 months. DISCUSSION Anatomic criteria for endovascular AAA treatment generally have included a proximal aneurysm neck less than 26 mm in diameter and 15 mm or more in length, without calcification or significant angulation (> 75 degrees). Distally, touchdown zones of 10 to 15 mm of aortic cuff (for the tube configuration) or 20 mm of nonaneurysmal iliac artery (for a bifurcated graft) have been standard requirements in trial protocols. Furthermore, the femoral and iliac vessels must be of sufficient caliber to accept the introducer sheath and have limited tortuosity. These relatively strict criteria have limited the applicability of the endovascular approach in many patients. In the initial phase I trial, Moore and Rutherford4 reported that the endovascular tube graft would be applicable in only 13% of all patients with AAA. Other investigators have estimated that the percentage of AAA anatomically suitable to endovascular tube graft repair is even less.6 More worrisome, however, is the existence of some evidence suggesting that the tube graft configuration may have a higher failure

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Patency Reference Perler23 Schneider24 Brener25 Criado26 Dick27

Year 1994 1994 1993 1993 1980

Patients 1 year (%) 5 year (%) 44 91 228 110 133

81* 83*

59* 60*† 55* 60* 73.3‡

*Primary. †Three-year data. ‡Cumulative.

rate than either the bifurcated or aortouniiliac device. In a study by May et al,8 the incidence of early and late endoleaks was significantly higher in those patients receiving a tube endograft. Kaplan-Meier curves showed a probability of success in 50% of tube grafts and 80% of nontube grafts. The introduction of bifurcated endoprostheses was predicted to allow endovascular repair in a greater number of patients with a higher degree of success.9 In a review of 154 abdominal CT scans, however, Armon et al6 found only six patients (4%) suitable for an endovascular tube graft and 15 patients (10%) suitable for a bifurcated endoprosthesis. Similarly, Balm et al10 described 18 patients treatable by bifurcated endografts out of 66 CT scans reviewed. In a subsequent clinical trial, Treiman et al5 evaluated 164 consecutive patients with AAA for endovascular grafting and found that less than 20% of their patients were treatable with devices available at that time. In this group, insufficient distal neck, iliac occlusive disease, or iliac stenosis was the primary contraindication to an endovascular approach in nearly 50% of the patients. It is likely that endovascular repair will be appropriate for a larger number of patients as the availability of bifurcated, modular grafts becomes available. However, even with the availability of such devices, patients with complex pelvic aneurysmal disease will remain challenging. The application of aortouniiliac stent graft and cross-pelvic bypass graft may extend the potential of an endoluminal repair to the patient with complex or extensive pelvic aneurysmal disease who might not otherwise be treated. Indeed, as many as 60% of all aneurysms may be treatable by this approach.1,6 In the discussion of the Treiman paper, the author concludes that as many as 40% of the patients previously excluded would have been potential candidates for unilateral aortoiliac/femorofemoral bypass grafting. The limitation of this approach has

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principally been some reticence to the usage of the femorofemoral bypass. Historically, 5-year primary patency rates of femorofemoral grafts have been less than aortobifemoral grafts, to which they are most often compared. Recent studies reveal 5-year primary patencies of the femorofemoral graft (placed for occlusive disease) ranging from 55% to 73% (Table IV). In our study, albeit with only 15.8-months’ follow-up, we have found 98% primary patency. This compares favorably with other recent studies and may be somewhat higher (Table IV). Others have suggested that patency of extra-anatomic grafts may vary depending on the indication for bypass graft.11,12 Because most patients with primary aneurysmal disease have intact runoff, an extension of that hypothesis might suggest that femorofemoral grafts placed for aneurysmal disease will have overall higher patency than those placed for occlusive disease. Our experience and those of several other groups11,12 support that contention. Early studies of the aortouniiliac endograft with femorofemoral bypass graft in the setting of occlusive disease have had relatively good outcomes, although follow-up and numbers are limited.13-15 In a recent review of early femorofemoral graft complications after aortouniiliac endograft placement, Walker et al16 followed up 136 patients over a median follow-up of 7 months. They found an overall complication rate of 13% attributable solely to the femorofemoral bypass graft. These included 2 infected grafts, 1 thrombosed graft, 1 pseudoaneurysm, and 7 groin hematomas (3 of which required operative intervention). Clearly, the benefits of an endovascular approach to AAA repair (such as decreased blood loss, decreased use of intensive care units and earlier discharge1) do not come freely. Complications occurred in 38% of patients in our series. This is within the range of those generally reported with endovascular graft configurations of 10% to 50%.1-4,17 A recent report by May et al18 describing their large experience with AAA repair also noted an adverse event rate of 45%. Most complications in our series, however, did not significantly affect the clinical course or outcome of patients. Graft kinking or stenosis was noted in four of our patients, all in patients receiving unsupported endografts. Only one of these resulted in graft thrombosis, but all required secondary endovascular interventions (stenting) for symptoms. The incidence of endoleaks does not appear to be higher with the aortouniiliac approach than with other endovascular grafts.16,19-21 Because inferior mesenteric artery occlusion is commonplace with aneurysmal disease and ensured

with endograft placement, the occlusion of one or both hypogastric arteries associated with aortouniiliac grafting has raised the concern for the potential of ischemic colitis. This was seen in one patient of the six with bilateral hypogastric artery occlusion. The patient had abdominal pain, leukocytosis, and diarrhea. Colonoscopy indicated probable ischemic colitis on the fifth postoperative day. The patient was maintained on broad-spectrum antibiotics and bowel rest and recovered uneventfully. Similar events have been noted previously in endovascular aortouniiliac grafting for both abdominal aortic and iliac aneurysmal disease.21,22 CONCLUSION Endovascular aortouniiliac grafting with concomitant femorofemoral bypass graft should allow an endovascular approach to a broader range of patients with abdominal aortic and aortoiliac aneurysmal disease. This study suggests that effective aneurysm exclusion can be achieved with acceptable morbidity using this strategy. The relative aversion to the use of the femorofemoral bypass graft required by this approach appears unfounded. As with most studies in which enthusiasm is high and follow-up is relatively limited, long-term analysis will be required to confirm these early data. REFERENCES 1. Brewster DC, Geller SC, Kaufman JA, Cambria RP, Gertler JP, LaMuraglia GM, et al. Initial experience with endovascular aneurysm repair: comparison of early results with outcome of conventional repair. J Vasc Surg 1998;27:992-1005. 2. May J, Woodburn K, White G. Endovascular treatment of infrarenal abdominal aortic aneurysms. Ann Vasc Surg 1998;12:391-5. 3. May J, White GH, Yu W, Ly CN, Waugh R, Stephen MS, et al. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method. J Vasc Surg 1998;27:21320; discussion 220-1. 4. Moore WS, Rutherford RB. Transfemoral endovascular repair of abdominal aortic aneurysm: results of the North American EVT phase 1 trial. EVT Investigators. J Vasc Surg 1996;23:543-53. 5. Treiman GS, Lawrence PF, Edwards WH Jr, Galt SW, Kraiss LW, Bhirangi K. An assessment of the current applicability of the EVT endovascular graft for treatment of patients with an infrarenal abdominal aortic aneurysm. J Vasc Surg 1999;30:68-75. 6. Armon MP, Yusuf SW, Latief K, Whitaker SC, Gregson RH, Wenham PW, et al. Anatomical suitability of abdominal aortic aneurysms for endovascular repair. Br J Surg 1997;84:178-80. 7. Ahn SS, Rutherford RB, Johnston KW, May J, Veith FJ, Baker JD, et al. Reporting standards for infrarenal endovascular abdominal aortic aneurysm repair. J Vasc Surg 1997;25:405-10. 8. May J, White GH, Yu W, Waugh R, Stephen MS, Arulchelvam M, et al. Importance of graft configuration in outcome of endo-

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nal aortic aneurysms: a comparison during two successive periods of time. J Vasc Surg 1999;29:32-7; discussion 38-9. Kato N, Dake MD, Semba CP, Razavi MK, Kee ST, Slonim SM, et al. Treatment of aortoiliac aneurysms with use of singlepiece tapered stent-grafts. J Vasc Interv Radiol 1998;9:41-9. Thompson MM, Sayers RD, Nasim A, Boyle JR, Fishwick G, Bell PR. Aortomonoiliac endovascular grafting: difficult solutions to difficult aneurysms [see comments]. J Endovasc Surg 1997;4:174-81. Yusuf SW, Whitaker SC, Chuter TA, Ivancev K, Baker DM, Gregson RH, et al. Early results of endovascular aortic aneurysm surgery with aortouniiliac graft, contralateral iliac occlusion, and femorofemoral bypass. J Vasc Surg 1997;25:165-72. Marin ML, Veith FJ, Lyon RT, Cynamon J, Sanchez LA. Transfemoral endovascular repair of iliac artery aneurysms. Am J Surg 1995;170:179-82. Perler BA, Williams GM. Does donor iliac artery percutaneous transluminal angioplasty or stent placement influence the results of femorofemoral bypass? Analysis of 70 consecutive cases with long-term follow-up. J Vasc Surg 1996;24:363-9. Schneider JR, Besso SR, Walsh DB, Zwolak RM, Cronenwett JL. Femorofemoral versus aortobifemoral bypass: outcome and hemodynamic results. J Vasc Surg 1994;19:43-55; discussion 55-7. Brener BJ, Brief DK, Alpert J, Goldenkranz RJ, Eisenbud DE, Huston J, et al. Femorofemoral bypass: a twenty-five year experience. In: Yao JST, Pearce WH, editors. Long-term results in aortic surgery. Norwalk (CT): Appleton and Lange; 1993. p. 385-93. Criado E, Burnham SJ, Tinsley EA, Johnson G, Keagy BA. Femorofemoral bypass graft: analysis of patency and factors influencing long-term outcome. J Vasc Surg 1993;18:495-505. Dick LS, Brief DK, Alpert J, Brener BJ, Goldenkranz R, Parsonnet V. A 12-year experience with femorofemoral crossover grafts. Arch Surg 1980;115:1359-65.

Submitted Oct 12, 1999; accepted Feb 18, 2000.