Percutaneous AAA Repair: Is It Safe?

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1 J ENDOVASC THER 621 CLINICAL INVESTIGATION Percutaneous AAA Repair: Is It Safe? Gabriel Börner, MD 1 ; Krasnodar Ivancev, MD, PhD 2 ; Björn Sonesson, MD, PhD 1,2 ; Bengt Lindblad 1, MD, PhD; Dennis Griffin, MD 3 ; and Martin Malina, MD, PhD 1,2 Departments of 1 Vascular Surgery and 2 Radiology, Lund University, Malmö, Sweden. 3 Radiology Imaging Associates, Radiology Department, Columbia Swedish Medical Center, Englewood, Colorado, USA. Purpose: To assess if percutaneous insertion of large-bore sheaths is safe during endovascular repair (EVR) for abdominal aortic aneurysms (AAA). Methods: Ninety-five AAA patients undergoing EVR had the endografts implanted percutaneously via 14-F to 20-F sheaths in a prospective nonrandomized study. Vascular sutures were applied bilaterally to the common femoral arteries using a vascular closure device; the sutures were tied after sheath withdrawal. Blood loss, operative time, and length of stay (LOS) were compared to 26 AAA patients undergoing EVR with bilateral femoral cutdowns before the percutaneous technique was available. Follow-up included duplex ultrasonography and clinical examination. Results: Bilateral percutaneous closure of the femoral arteries was successful in 78 (82%) patients. Fifteen patients required arteriorrhaphy intraoperatively and 2 others within 24 hours. The failure rate was 20%, 0%, 3%, and 7% for the 20-F, 18-F, 16-F, and 14-F introducers, respectively. Blood loss was 400 ml (range ) in successful cases, 900 ml (range ) in failures (p0.0001). One deep infection at the puncture site required thrombectomy and patchplasty; no other late complication occurred. There was no significant difference in operative time, blood loss, and LOS between patients treated with percutaneous EVR and those with primary femoral exposure. Conclusions: Percutaneous transfemoral EVR of AAA using large-bore introducer sheaths is safe. More than three quarters of the patients avoid femoral cutdown. Late complications are rare. J Endovasc Ther Key words: abdominal aortic aneurysm, endovascular repair, stent-graft, vascular closure device, percutaneous repair Endovascular repair (EVR) of the abdominal aortic aneurysm (AAA) is increasingly accepted because it is associated with less surgical trauma than open repair. 1 The standard technique of stent-graft implantation involves bilateral groin dissection to expose the femoral arteries. However, femoral cutdown is associated with frequent local complications, and EVR is no exception. 2 6 A recent report of 186 patients undergoing EVR with femoral exposure for AAA presented an 8% wound infection rate; 6.5% of their patients developed wound necrosis, 4.8% had lymphocele, and 1.1% required re-exploration for hematoma. 7 Furthermore, insertion of the sheath into the exposed femoral arteries usually necessitates temporary clamping of the vessels, with subsequent interruption of lower limb perfusion Address for correspondence and reprints: Gabriel Börner, MD, Department of Vascular Surgery, Malmö University Hospital, S Malmö, Sweden. Fax: ; Gabriel.Borner@semera.se 2004 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at

2 622 PERCUTANEOUS AAA REPAIR J ENDOVASC THER and risk for thrombosis. Postoperative scar tissue makes future access to the femoral arteries more difficult. Percutaneous EVR has until recently been hindered by the relatively high profile of aortic stent-grafts. Most devices require introducer sheaths up to 20 F. Several low-profile devices have been introduced, but the durability of thin fabrics and stents remains an issue. Percutaneous insertion of large-bore introducer sheaths that accept robust stent-grafts is therefore warranted. The purpose of the present study was to assess the safety of percutaneous AAA repair with introducer sheaths up to 20-F inner diameter. 2,8 11 Study Design METHODS Under a protocol approved by the local ethical committee, all AAA patients undergoing EVR with a trimodular stent-graft (Zenith Trifab; Cook Inc., Bjaeverskov, Denmark) were candidates for percutaneous transfemoral delivery with large-bore sheaths unless open repair of the femoral vessels would be required to repair a significant lesion in the common, superficial, or deep femoral artery. Data collected for analysis included access-site complications, operative time, blood loss, and length of stay (LOS). A successful percutaneous procedure was defined as the ability to deliver the introducer sheath and achieve a secure closure of the puncture site without surgical cutdown, hemorrhage, or surgical repair of the access vessel. The study endpoints were femoral artery hemorrhage, pseudoaneurysm, stenosis, thrombosis, infection, or other device-related complications during follow-up. Operative time, blood loss, and LOS were compared to a control group of AAA patients treated with the same stent-graft model delivered via femoral cutdown. Patient Sample Between January 2001 to October 2003, 101 AAA patients were enrolled in the study. One patient was excluded because both percutaneous and open attempts to insert the sheath transfemorally failed due to bilateral iliac stenoses; the endograft was delivered via a retroperitoneal iliac approach. A second patient was excluded because femoral cutdown was required to remove a kinked intravascular ultrasound probe. Also excluded were 3 patients who died intraoperatively and a fourth patient who died on the fifth postoperative day (no meaningful follow-up). These 6 exclusions left 95 patients (81 men; mean age 74 years, range 54 87) for analysis. Eight interventions were emergencies due to rupture, and 13 patients had urgent repair due to symptomatic AAA; the remaining 74 procedures were elective. The control group included 26 patients treated by the same surgical team before the percutaneous technique was introduced at our institution ( ). There were no significant differences in the comorbidities or morphological measurements between the groups (Table 1). Percutaneous Technique In both groins, the common femoral artery was punctured anterior to the femoral head under fluoroscopic guidance. Correct puncture site between the femoral bifurcation and the inferior epigastric artery was confirmed by contrast injection prior to introducer sheath insertion. An 8-F catheter-based suture device (8-F Prostar; Perclose, Abbott Laboratories, Abbott Park, IL, USA) was passed over the guidewire into the femoral artery 8 to insert 2 nonresorbable multifilament 3 0 vascular sutures into the arterial wall at the puncture site. The 8-F Prostar was then exchanged over the wire for the 10-F Prostar, and 2 additional sutures were placed. The final introducer sheath containing the stent-graft was then inserted over a very stiff Lunderquist guidewire (Cook Inc.), which effectively dilated the puncture site containing the 4 vascular sutures (the so called pre-close technique). After completion of the endovascular repair and withdrawal of the sheath, the arterial sutures were tied with a sliding knot. The guidewire was left in place until satisfactory hemostasis was proven; it was then withdrawn, and compression was applied for 2 hours by means of an external compression device (FemoStop II PLUS; Radi Medical Systems AB, Uppsala, Sweden).

3 J ENDOVASC THER PERCUTANEOUS AAA REPAIR 623 TABLE 1 Comorbidities and Morphology in Patients Undergoing Endovascular AAA Repair Via Percutaneous or Surgical Access Percutaneous Access (n95) Cutdown Controls (n26) Comorbidities Diabetes 8 (8%) 2 (8%) Cardiac insufficiency 12 (13%) 4 (15%) Hypertension 48 (50%) 15 (57%) Myocardial infarction 30 (31%) 9 (35%) Smoking 65 (68%) 10 (38%) COPD 24 (25%) 6 (23%) Angina 12 (13%) 4 (15%) Diameters Aneurysm, mm* 59 (38 109) 55 (42 90) Ipsilateral iliac artery, mm 9 (5 11) 8 (5 15) Contralateral iliac artery, mm 9 (6 11) 8 (6 9) COPD: chronic obstructive pulmonary disease. Continuous data are presented as median (range). * Abdominal aortic aneurysms 50 mm in diameter were treated for concomitant iliac aneurysms. Represents the narrowest diameter along the common or external iliac artery in order to assess the difficulty of sheath insertion. Any hemorrhage due to failure of the closure device was immediately controlled by passing a 6 to 10-mm angioplasty balloon catheter over the wire into the femoral artery (Figure). The balloon was gently inflated and retracted until it obliterated the puncture site. Cutdown with arteriorrhaphy or patchplasty was then performed with conventional surgical technique. Statistical Analysis Data are presented as median (range). The Wilcoxon rank sum test was used for group comparisons; p0.05 was considered significant. RESULTS FigureManagement of closure device failure: (A) The Lunderquist wire is left in situ while the vascular sutures are tied. A 6 to 10-mm angioplasty balloon catheter is passed over the wire into the femoral artery in case of inadequate hemostasis. (B) The balloon is gently inflated and then retracted to obliterate the puncture site. The stent-graft procedures were performed under local (n25, 26%), epidural/spinal (n16, 17%), or general (n54, 57%) anesthesia. Percutaneous insertion of the devices was primarily successful in 170 (89%) of the 190 femoral arteries, achieving completely percutaneous EVR without exposure of the femoral artery on either side in 78 (82%) of the 95 patients. Intraoperative femoral cutdown due to closure failure with hemorrhage was required in 15 patients (18 groins), and 2 additional patients (2 groins) returned to the operating room due to hemorrhage within 24 hours. Of these 20 closure failures, the ma-

4 624 PERCUTANEOUS AAA REPAIR J ENDOVASC THER TABLE 2 Incidence of Closure Device Failure in Relation to Introducer Diameter 14 F (n30) 16 F (n64) Sheaths* 18 F (n20) 20 F (n80) Hemorrhage 2 (7%) 2 (3%) 0 16 (20%) * French size denotes the inner diameter. jority (n16, 80%) were associated with the largest introducer sheath (20-F inner diameter). The other 4 failures occurred with the 14- F and 16-F sheaths (Table 2). The blood loss, operative time, and LOS (Table 3) were similar for the 95 patients operated percutaneously compared to the 26 patients operated with primary femoral cutdown during 1998 to 1999 (p1.0, 0.1, and 0.2, respectively). Closure device failure with subsequent intraoperative cutdown significantly increased the blood loss (900 ml versus 400 ml, p0.0001) and the operative time (275 versus 180 minutes, p0.0001), but the LOS was not significantly affected (5 versus 4 days, p0.5). Late Results Follow-up included clinical examination of 88 patients at a median 49 days (range ); the remaining 7 patients, mainly from remote hospitals, reported no symptoms or re-interventions suggestive of closure devicerelated complications. Twenty-three of the early patients underwent duplex imaging of the puncture site at a median 80 days (range ). One late complication related to percutaneous stent-graft insertion required reintervention. The patient developed a deep wound infection at the puncture site with iliac artery thrombosis at 1 month. He was successfully treated with thrombectomy and venous patchplasty of the common femoral artery. One minor, 6-mm pseudoaneurysm detected by duplex ultrasonography at 2 months resolved spontaneously at 5 months. Two common femoral artery stenoses, 20% and 30%, respectively, were also identified; no symptoms referable to the stenoses were reported at the latest follow-up in these patients. DISCUSSION There are several potential advantages of percutaneous stent-graft implantation without surgical exposure of the femoral arteries. Previous studies suggest that the percutaneous technique may reduce operative time, blood loss, and LOS. 2,8,11 Future access to the femoral arteries is easier in the absence of a surgical scar. The minimal wound offers little discomfort, and complications that are encountered after cutdown, such as wound infection and lymphocele, are likely to be less frequent. 2 7 The present study shows that percutaneous EVR with sheaths up to 20-F inner diameter is feasible in more than three quarters of the patients, sparing the majority of groins from exposure of the femoral artery. TABLE 3 Operative Details and Length of Stay (LOS) in Patients Undergoing EVR Via Femoral Cutdown or Percutaneous Access All (n95*) Percutaneous Access Percutaneous Success (n78) Intraoperative Cutdown (n15) Cutdown Controls (n26) Blood loss, ml 450 (0 3000) 400 (0 1800) 900 (0 3000) 450 (0 1500) Operative time, min 180 ( ) 180 ( ) 275 ( ) 175 ( ) LOS, d 4 (1 16) 4 (1 16) 5 (2 11) 5 (2 23) Data presented as median (range). * Includes 2 patients with postoperative hemorrhage and postoperative femoral cutdown. p versus percutaneous success group.

5 J ENDOVASC THER PERCUTANEOUS AAA REPAIR 625 Failure of the closure device occurs occasionally with any size of introducer sheath, but seems to be more frequent with the largest sheaths. The precise mechanism of failure is unknown, although greater vessel damage by the largest sheaths seems logical. Percutaneous thoracic interventions with 24-F sheaths (27-F outer diameter) are associated with a failure rate of about 30%. 12 Some failures may be caused by inadequate insertion of the sutures due to either excessive vessel wall calcification or simply unintentional insertion of the sutures into the superficial fascia instead of the vessel wall. Insertion of the largest sheaths may also tear off the suture from the vessel wall. We found no obvious correlation between the morphology of the inguinal region and the success rate of the closure device. Seemingly hostile groins appeared equally suitable for percutaneous repair as others. Patients with a hostile groin may particularly benefit from the percutaneous technique because cutdown is more laborious and associated with more frequent local complications. Occasional failure of the closure device is detected intraoperatively and can easily be managed. It is noteworthy that the vascular sutures hinder reinsertion of the large sheath, which is why a low profile angioplasty balloon is used instead to control hemorrhage. Failure of the closure device is usually recognized in the operating room before the guidewire is withdrawn, and very few patients need to return to the operating room due to late bleeding. Both of the patients with postoperative hemorrhage requiring open repair of the femoral artery occurred early in our series; in retrospective, primary hemostasis was inadequate, and immediate intraoperative arteriorrhaphy should have been performed. There was no late hemorrhage, and no significant pseudoaneurysm developed in this series of patients. As the femoral artery is never clamped during percutaneous repair, perfusion of the limbs is usually preserved throughout the operation, as some blood flow still remains beside the sheaths in most patients. No peripheral thrombosis, embolism, or complication from reperfusion was encountered in our series. The patient who developed a deep wound infection and iliac artery thrombosis also occurred early in this series. Infection associated with the closure device has been reported in the literature The pre-close technique implies that the vascular sutures are placed at the beginning of the procedure. The sutures are usually left on the skin of the inguinal region throughout the operation. This particular case prompted us to improve the draping of our patients. We now routinely use sterile adhesive plastic to cover the groins and avoid skin contact with the sutures. No further infections have occurred after these routines were modified in this fashion. The present study supports the view that local wound complications may be less frequent after percutaneous EVR. While some investigators have reported reduced blood loss and shorter operation times and LOS in patients operated with the percutaneous technique, 2,8,11 Morasch et al. 18 noted only very modest improvements. Disappointingly, we did not see an improvement in these parameters in the present study. Although a type II error cannot be ruled out, it seems unlikely that there is a clinically significant difference between the groups. Femoral cutdown is expedient and associated with little blood loss. The length of stay reflects the multiple comorbidities of this elderly population rather than the type of arterial access. Nevertheless, the surgeons and the radiologists involved in the present study agree that percutaneous access is more convenient because it offers a purely catheter-based intervention. The presence of surgical staff and surgical instruments is required only in a minority of cases toward the end of the procedure after the endovascular repair has been accomplished. The additional cost of the closure device is partly compensated by reduced need for staff (one radiology assistant) and surgical equipment (no need for retractors, diathermy, etc.). The cost of the closure devices constitutes a small proportion of the overall cost of EVR of AAAs. Percutaneous access seems particularly advantageous in endovascular repair of ruptured aneurysms. It facilitates the use of local anesthesia, and no surgical staff or surgical instruments are needed. Avoiding general anesthesia is favorable for patients in pre-shock,

6 626 PERCUTANEOUS AAA REPAIR J ENDOVASC THER and the simplicity of percutaneous sheath insertion makes the procedure more expedient. However, there may be no time to apply a closure device in patients with a ruptured aneurysm. Safe hemostasis can be provided by the aforementioned balloon technique after the ruptured aneurysm has been successfully excluded. The patient is usually more stable at this stage and tolerates general anesthesia better. Unhurried arteriorrhaphy or crossover bypass is added, depending on the type of stent-graft selected. In conclusion, percutaneous AAA repair with large-bore introducer sheaths is feasible and safe. Occasional closure device failure is easily managed intraoperatively. Late complications are rare. REFERENCES 1. Adriaensen ME, Bosch JL, Halpern EF, et al. Elective endovascular versus open surgical repair of abdominal aortic aneurysms: a systemic review of short-term results. Radiology. 2002; 224: Torsello GB, Kasprzak B, Klenk E, et al. Endovascular suture versus cutdown for endovascular aneurysm repair: a prospective randomized pilot study. J Vasc Surg. 2003;38: Cohnert TU, Oelert F, Wahlers T, et al. Matchedpair analysis of conventional versus endoluminal AAA treatment outcomes during the initial phase of an aortic endografting program. J Endovasc Ther. 2000;7: Treharne GD, Thompson MM, Whiteley MS, et al. Physiological comparison of open and endovascular aneurysm repair. Br J Surg. 1999; 86: Moore WS, Kashyap VS, Vescera CL, et al. Abdominal aortic aneurysm: a 6-year comparison of endovascular versus transabdominal repair. Ann Surg. 1999;230: Patel AP, Langan EM3rd, Taylor SM, et al. An analysis of standard open and endovascular surgical repair of abdominal aortic aneurysms in octogenarians. Am Surg. 2003;69: Dalainas I, Nano G, Casana R, et al. Mid-term results after endovascular repair of abdominal aortic aneurysms: a four-year experience. Eur J Vasc Endovasc Surg. 2004;27: Traul DK, Clair DG, Bray B, et al. Percutaneous endovascular repair of infrarenal abdominal aortic aneurysms: a feasibility study. J Vasc Surg. 2000;32: Howell M, Villareal R, Krajcer Z. Percutaneous access and closure of femoral artery access sites associated with endoluminal repair of abdominal aortic aneurysms. J Endovasc Ther. 2001;8: Teh LG, Sieunarine K, van Schie G, et al. Use of the percutaneous vascular surgery device for closure of femoral access sites during endovascular aneurysm repair: lessons from our experience. Eur J Vasc Endovasc Surg. 2001; 22: Howell M, Doughtery K, Strickman N, et al. Percutaneous repair of abdominal aortic aneurysms using the AneuRx stent graft and the percutaneous vascular surgery device. Catheter Cardiovasc Interv. 2002;55: Malina M, Börner G, Ivancev K. Large introducer sheaths without cutdown: a 3-year experience of percutaneous aneurysm repair with sheaths up to 27-F outer diameter [Abstract]. J Endovasc Ther. 2004;11(Suppl 1):I Boston US, Panneton JM, Hofer JM, et al. Infectious and ischemic complications from percutaneous closure devices used after vascular access. Ann Vasc Surg. 2003;17: Geary K, Landers JT, Fiore W, et al. Management of infected femoral closure devices. Cardiovasc Surg. 2002;10: Cherr GS, Travis JA, Ligush J Jr, et al. Infection is an unusual but serious complication of a femoral artery catheterization site closure device. Ann Vasc Surg. 2001;15: Pipkin W, Brophy C, Nesbit R, et al. Early experience with infectious complications of percutaneous femoral artery closure devices. J Vasc Surg. 2000;32: Johanning JM, Franklin DP, Elmore JR, et al. Femoral artery infections associated with percutaneous arterial closure devices. J Vasc Surg. 2001;34: Morasch MD, Kibbe MR, Evans ME, et al. Percutaneous repair of abdominal aortic aneurysm. J Vasc Surg. 2004;40:12 16.

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