Open Versus Endovascular AAA Repair in Patients Who Are Morphological Candidates for Endovascular Treatment

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1 00;9: CLINICAL INVESTIGATION Open Versus Endovascular AAA Repair in Patients Who Are Morphological Candidates for Endovascular Treatment Bradley B. Hill, MD; Yehuda G. Wolf, MD; W. Anthony Lee, MD; Frank R. Arko, MD; Cornelius Olcott IV, MD; Peter J. Schubart, MD, PhD; Ronald L. Dalman, MD; E. John Harris, MD; Thomas J. Fogarty, MD; and Christopher K. Zarins, MD Division of Vascular Surgery, Stanford University Medical Center, Stanford, California, USA Purpose: To compare the outcomes of open versus endovascular repair of abdominal aortic aneurysm (AAA) in a cohort of patients who fulfill morphological criteria for endovascular repair. Methods: A retrospective review of 9 consecutive AAA patients treated over a -year period identified 49 patients who were candidates for endovascular repair based on preoperative computed tomography and angiography. Of the 49 patients, 79 (68 men; mean age 74 8 years) underwent endovascular repair with the AneuRx stent-graft; the remaining 70 (56 men; mean age 7 8 years) had open repair. Short-term outcome measures were 0-day mortality and procedure-related morbidity, length of stay in the intensive care unit and hospital, intraoperative blood loss, interval to oral diet, and time to ambulation. Long-term outcome measures included death and secondary procedures. Results: There was no difference in the 0-day mortality between endovascular repair (,.5%) and open repair (,.9%), even though endovascular patients had more comorbidities (p0.05). Overall length of stay was reduced for endovascular patients (.9.4 days versus 7.7. days for surgical patients, p0.000). Fewer endograft patients had complications (4% versus 40% for open repair, p0.05), and the severity of these complications was less, as evidenced by the shorter hospital stays for endovascular patients with complications compared to conventionally treated patients with complications (6.7.4 days versus.5 5. days, p0.05). There were no aneurysm ruptures or late surgical conversions in either group. Conclusions: Patients with AAA who were endograft candidates but who were treated with open repair experienced more morbidity and had more complications than patients treated with stent-grafts. Despite increased comorbidities in the endograft patients, there was no increase in mortality compared to open repair. Both treatments required secondary procedures and appeared to be equally effective in preventing aneurysm rupture up to years. J Endovasc Ther 00;9:55 6 Key words: AneuRx stent-graft, aneurysm morphology, outcome analysis, complications, mortality Disclosure: Thomas J. Fogarty and Christopher K. Zarins hold consulting arrangements with Medtronic AVE and own stock in Medtronic. Address for correspondence and reprints: Bradley B. Hill, MD, Division of Vascular Surgery, Stanford University Medical Center, 00 Pasteur Drive, H-68, Stanford, CA USA. Fax: ; 00 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at

2 56 AAA TREATMENT COMPARISON J ENDOVASC THER 00;9:55 6 The incidence of abdominal aortic aneurysm (AAA) is increasing, and up to 50% of patients afflicted die within 5 years if not treated., Conventional open aneurysm repair is effective in preventing death from rupture but is associated with high morbidity (5% to 0%) and mortality (% to 5%).,4 Endovascular aneurysm repair provides a less invasive alternative to open surgery, 5 with reduced operative blood loss, decreased perioperative morbidity, decreased intensive care unit (ICU) and hospital stays, and earlier return to function compared to open aneurysm repair. 6 However, surgical control patients have varied among studies, and it is not clear that control patients have aneurysm morphology amenable to endoluminal treatment. Thus, a worse outcome after open repair may be related to more advanced and morphologically complex aneurysmal disease. To eliminate this possible bias, we compared outcomes of open and endovascular repair in 49 consecutive patients who were all candidates for endovascular repair based on arterial anatomy. Study Design METHODS From August 995 through November 998, 9 patients with AAA were treated at our institution. A panel of vascular surgeons and radiologists blinded to the treatment details retrospectively reviewed the preoperative imaging data from these patients to determine who would have been candidates for an endograft procedure based on morphological criteria from the multicenter trial of the AneuRx stent-graft (Medtronic AVE, Santa Rosa, CA, USA): () proximal aortic neck diameter 6 mm and length 0 mm, () fusiform aneurysm diameter 5 cmor4 cm with a documented 5-mm increase during the prior 6 months, or a saccular aneurysm cm in diameter, and () iliac arteries 6 mm in diameter. This review excluded 80 (5%) patients who had unsuitable anatomy: 48 (60% or % of entire cohort) had an absent, short, or tortuous proximal neck; 6 (0% or 7% of entire cohort) had aneurysmal or occluded iliac arteries, and 6 (0%) had branch vessels requiring reconstruction. Patency of the inferior mesenteric artery (IMA) did not exclude any patient from candidacy for endovascular repair because none of the patients had a patent IMA and occlusion of both hypogastric arteries. Patient Population Among the remaining 49 (65%) patients (Table ) who would have been candidates for endovascular repair, 70 (56 [80%] men; mean age 7 8 years, median 7) had open surgery, and 79 (68 [86%] men; mean age 74 8 years, median 74) received the bifurcated AneuRx stent-graft as part of a prospective FDA-approved multicenter clinical trial of this device. 6 The technique for endoluminal repair was reviewed and approved by the Institutional Review Board, and each patient gave informed consent to participate in the multicenter study. 6 Open and Endovascular Procedures All endograft procedures were performed in the operating room with patients prepared and draped for conversion to open repair should it be required. General endotracheal anesthesia (89%) or epidural anesthesia (%) with general sedation was utilized. Prophylactic antibiotics were routinely administered. Patients were anticoagulated with heparin (00 U/kg) before device insertion. Device selection was based on preoperative imaging studies; however, intravascular ultrasonography was used early in our experience to help with sizing. Intraoperative angiography was performed to guide device deployment, with completion angiography used to confirm satisfactory aneurysm exclusion in all cases. Patients who underwent endovascular aneurysm repair were studied with contrast-enhanced computed tomography (CT) and color duplex ultrasonography prior to discharge and at month postoperatively. CT scans were obtained at 6 and months postoperatively and annually thereafter. Patients with endoleak were followed at more frequent intervals as long as the aneurysm size remained stable or increased. Patients with obvious fixation site endoleaks, persistent endoleaks,

3 00;9:55 6 AAA TREATMENT COMPARISON 57 TABLE Patient Demographics, Risk Factors, and Aneurysm Morphology (n 70) (n 79) p Age, y Men Risk factors Hypertension Diabetes mellitus Comorbidities Cardiac disease* Chronic obstructive pulmonary disease Renal insufficiency Cerebrovascular disease Aneurysm morphology Aneurysm size, mm Neck diameter, mm Neck length, mm (80%) 44 (6%) (.4%) 4 (6%) 4 (0%) 8 (%) 5 (7%) (86%) 44 (56%) (4%) 59 (75%) (9%) 6 (8%) 8 (%) Continuous data are given as mean SD. not significant. * Previous myocardial infarction, congestive heart failure, cardiac arrhythmia, or symptomatic valvular heart disease requiring treatment. Symptomatic obstructive pulmonary disease requiring treatment. Serum creatinine.5 mg/dl. Stroke or documented carotid artery disease. new endoleaks, or aneurysm enlargement were studied with angiography and treated with secondary endoluminal procedures. Patients who underwent open surgical repair had general endotracheal anesthesia. Aneurysms were exposed through a midline or transverse transabdominal incision (%) or a left flank retroperitoneal approach (67%). Patients were anticoagulated with heparin before arterial clamping. Polyester fabric aortic grafts were utilized: tube grafts in 4 (6%) and bifurcated grafts in 7 (9%), of which were aortoiliac, 4 were aortobifemoral, and was an aortoiliofemoral reconstruction. The IMA was reimplanted in 8 (%) patients. Follow-up was conducted by office visit, examination, and telephone interviews. Patients who had open repair did not have routine postoperative imaging studies. All patients were admitted to the ICU following endovascular and open repair. Statistical Analysis Based on a retrospective analysis, primary short-term outcome measures were 0-day mortality and procedure-related morbidity. Complications that resulted in death, organ system failure, or reoperation before discharge were classified as major, while all others were minor. Secondary outcome measures included length of stay (LOS) in ICU and in hospital, intraoperative blood loss, time from operation to initiation of oral diet, and time from operation to ambulation. Longterm outcome measures included death and secondary procedures. The results are expressed as mean standard deviation. Differences between groups were evaluated with chi-square test and - or -tailed Student t test. Differences were reported as significant if p0.05. RESULTS There were no differences in aneurysm diameter or proximal neck dimensions (Table ), and the patient groups were well matched in terms of age and sex distribution. There were more diabetics in the endograft group, as well as a larger proportion of patients with chronic obstructive pulmonary disease and cerebrovascular disease (all p0.05). Endovascular repair was completed in 78

4 58 AAA TREATMENT COMPARISON J ENDOVASC THER 00;9:55 6 TABLE Complications Within 0 Days (n 70) (n 79) p Overall Major* Hemorrhagic shock, death (reop in ) Multisystem organ failure (reop in ) Pneumonia Reop: ureteral obstruction, anuria Retroperitoneal hematoma Myocardial infarction Congestive heart failure Ischemic colitis (no surgery) Reop: femoral artery thrombosis Extender cuff for endoleak Reop: repair iliac artery tear Reop: repair femoral pseudoaneurysm Reop: release entrapped nerve Minor Cardiac (arrhythmia, pulmonary edema) Pulmonary (extubation 4 h postop) Gastrointestinal (prolonged ileus) Dislocated arytenoid from intubation Tape/cautery pad burns Suppurative superficial phlebitis Genitourinary (retention, trauma, UTI) Delirium Retroperitoneal hematoma (no reop) Brachial pseudoaneurysm (no reop) Groin wound infection/cellulites Groin hematoma 8 (40%) (6%) 7 (4%) 5 9 (4%) (4%) Reop reoperation, UTI urinary track infection. * Complication resulted in death, organ system failure, or reoperation (0%) 0.05 (99%) patients; one case was converted because access could not be achieved through small iliac arteries. Sixteen patients (0%) required extender cuffs for proximal seal and 8 (5%) required iliac extender cuffs for distal seal as part of the primary procedure. There was no in-hospital mortality among the endograft patients; however, patients who had undergone uneventful procedures died unexpectedly of myocardial infarction and 4 weeks after hospital discharge. There were (.9%) perioperative deaths in the surgical group owing to intraoperative and postoperative hemorrhage, respectively, with postoperative multisystem organ failure. Complications There were more complications (Table ) in the surgical group (8, 40%) versus 9 (4%) in the endograft group (p0.05). While the number of major complications (n ) was the same in both cohorts, the events were more serious in the operative group, leading to death in cases and multiorgan failure in others. Four (5.7%) surgical patients required reoperation. One had an intraoperative splenic tear that necessitated re-exploration and splenectomy. Another reoperation was necessary to relieve a ureteral kink that caused anuria in a patient with a solitary kidney. Five (6.%) of the endograft patients required reoperation or secondary procedures before hospital discharge to repair an iliac artery tear, a femoral pseudoaneurysm, an entrapped nerve, and a femoral artery thrombosis. One extender cuff was implanted for a proximal endoleak.

5 00;9:55 6 AAA TREATMENT COMPARISON 59 TABLE Hospital Course (n 70) (n 79) p Blood loss, ml Overall LOS, d LOS in patients with complications, d ICU LOS, d Intubation time, d Interval to normal diet, d Interval to ambulation, d LOS length of stay, ICU intensive care unit Hospital Course Blood loss (Table ) was significantly less in the endovascular group ( ml, median 500) than in the open repair group ( ml, median 000; p0.05). The hospital LOS (Table ) was significantly shorter in the endograft patients (.9.4 days versus 7.7. days in the surgical patients, p0.000), as were the ICU stay (p0.05) and mean duration of intubation (p). Patients having endovascular repair resumed oral diet sooner (p0.000) and ambulated earlier (p0.000) than those having open repair. Moreover, the overall hospital LOS in surgical patients with complications (.5 5. days) was significantly longer compared to endovascular patients with complications (6.7.4 days; p0.05) verifying that the magnitude of complications was greater in the open group. All late deaths Cardiac Pulmonary Liver failure (chronic) Renal failure Cancer Stroke/neurological Unknown cause TABLE 4 Late Deaths (n 5)* (5%) (n 79) p 5 (9%) 5 0 * 5 of 70 patients followed at a mean 5 5 months (range 9 months). All 79 patients followed at a mean 6 9 months (range 9 months). Outcome Beyond 0 Days Follow-up was complete in 5 of 70 open surgical patients at a mean 4 5 months (range 9, median ) and all 79 endovascular patients (6 9 months, range 9, median ). Late deaths (Table 4) occurred in (5%) of the 5 surgical patients with follow-up and 5 (9%) endograft patients (); no deaths were aneurysm related. No longterm graft-related complications were identified in the surgical patients, and there were no aneurysm ruptures or late surgical conversions in any patient. The Kaplan-Meier survival analysis (Figure) showed no difference between the groups ( 0.008, p0.9 for comparison between early deaths and late deaths/alive with Yates correction; 0.5, p0.698 for comparison between early and late deaths with Yates correction). Endoleaks were present in (5%) endograft patients at month; patients had endovascular procedures for proximal endoleak within year. Overall, 9 (4%) endograft patients had secondary procedures with extender cuffs to secure device fixation, most without endoleak or aneurysm expansion. DISCUSSION This study compares endovascular and open repair of infrarenal abdominal aortic aneurysms in consecutive, morphologically matched patients, all of whom were anatomical candidates for endovascular repair. Although the endovascular group had more comorbidities than the surgical group, there was no difference in 0-day mortality (%) be-

6 60 AAA TREATMENT COMPARISON J ENDOVASC THER 00;9:55 6 FigureKaplan-Meier survival curves of open versus endovascular AAA repair. The differences between early and late deaths are not statistically significant. tween groups; however, the circumstances of early deaths were quite different. Both endovascular patients who died within 0 days had myocardial infarction after technically successful, uncomplicated endovascular repair. The deaths were unexpected in light of the patients preoperative cardiac evaluations by a cardiologist. Two open surgical patients, on the other hand, died from the effects of hemorrhagic shock during the operative procedure. In the open repair group, the overall complication rate and severity of complications were greater, the latter evidenced by longer hospitalization in the open repair patients. patients had less operative blood loss, earlier resumption of oral diet, and faster return to ambulation compared to patients who had open repair. Long-term survival was no different between the groups, with the most common cause of death being cardiac-related. Local incisional and vascular access-related complications occurred more frequently following endovascular repair, whereas systemic type complications were more common after conventional surgery. Most of the access complications in the endograft patients occurred early in our experience. Now, we approach the femoral artery through short oblique incisions above the groin crease instead of longitudinal incisions to minimize wound complications, and we avoid iliac arterial injuries by using the common iliac artery for device insertion if the external iliac arteries are small. It should be mentioned that many patients were referred for endovascular repair because they were not candidates for open repair, whereas no one referred for open surgery was not a surgical candidate. This difference is apparent in the higher prevalence of diabetes mellitus, cerebrovascular disease, and chronic obstructive pulmonary disease in the endovascular group than in the open surgical group. Although the patients who had open AAA repair were treated consecutively, and none were missed during the study period, a retrospective review by design may overlook complications, so gaps in the open surgical group data may be more common than in the endovascular group. Furthermore, the stringent follow-up protocol with periodic imaging studies for the endovascular group lessens the likelihood of a missed endoleak, device failure, or other complication. The open repair patients, to the contrary, did not have imaging follow-up, and most were not seen in the vascular surgery clinic beyond the sixth postop-

7 00;9:55 6 AAA TREATMENT COMPARISON 6 erative month. Despite telephone calls to encourage follow-up visits, many patients were lost to follow-up. Moreover, telephone contacts were not always effective in assessing clinical or graft status; thus, it is possible that anastomotic aneurysms or other graft-related problems might not have been detected. Endovascular repair has favorable shortterm results. However, there are important unanswered questions relating to the longterm durability of aortic stent-grafts. Some investigators have suggested that endoleak is a meaningful measure of procedural success or failure, but this has not been proven and requires long-term study. The EUROSTAR data suggest that endoleak is a significant predictor, but analysis of the AneuRx database does not confirm this contention. Rather, the existing data suggest that early postprocedural endoleaks usually result from errors in case selection, technical problems with device deployment or positioning, or patent branch vessels. Late endoleaks that arise months or years after endovascular repair in the absence of a previous endoleak may be related to aneurysm morphology changes, device migration, insecure device fixation, or structural device failure. Their presence should prompt secondary procedures, either endoluminal manipulations or open repair, to exclude the aneurysm and prevent rupture. Inadequate proximal and distal device fixation (-cm circumferential contact between device and artery wall) even in the absence of endoleak should also prompt secondary procedures to secure fixation and prevent aneurysm rupture. In conclusion, a majority of AAA patients are candidates for endovascular repair. Patients who undergo endovascular repair experience fewer complications, have a shorter hospital stay, and have faster recovery than comparable patients who are treated with open surgical repair. Both treatment modalities are equally effective in preventing aneurysm rupture. These benefits must be balanced against the need for continued aneurysm surveillance and the possible need for secondary treatment in patients treated with stent-grafts. Acknowledgments: We thank Alison Kerr, RN, Christine Corcoran, RN, and Angie Drake, RN, for data collection and Rita R. Wedell for preparation of the manuscript. REFERENCES. Nevitt MP, Ballard DJ, Hallett JW. Prognosis of abdominal aortic aneurysms. A populationbased study. N Engl J Med. 989;: Johansson G, Nydahl S, Olofsson P, et al. Survival in patients with abdominal aortic aneurysms. Comparison between operative and nonoperative management. Eur J Vasc Surg. 990;4: Johnston KW. Multicenter prospective study of nonruptured abdominal aortic aneurysm. Part II. Variables predicting morbidity and mortality. J Vasc Surg. 989;9: Cambria RP, Brewster DC, Abbott WM, et al. The impact of selective use of dipyridamolethallium scans and surgical factors on the current morbidity of aortic surgery. J Vasc Surg. 99;5: Blum U, Voshage G, Lammer J, et al. Endoluminal stent-grafts for infrarenal abdominal aortic aneurysms. N Engl J Med. 997;6: Zarins CK, White RA, Schwarten D, et al. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 999;9: Brewster DC, Geller SC, Kaufman JA, et al. Initial experience with endovascular aneurysm repair: comparison of early results with outcome of conventional open repair. J Vasc Surg. 998;7: May J, White G, Yu W, et al. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 0 patients by life table method. J Vasc Surg. 998;7:. 9. Moore WS, Kashyap VS, Vescera CL, et al. Abdominal aortic aneurysm: a 6-year comparison of endovascular versus transabdominal repair. Ann Surg. 999;0: Becquemin JP, Lapie V, Favre JP, et al. Midterm results of a second generation bifurcated endovascular graft for abdominal aortic aneurysm repair: the French Vanguard trial. J Vasc Surg. 999;0: Cuyers P, Buth J, Harris PL, et al. on behalf of the EUROSTAR Collaborators. Realistic expectations for patients with stent-graft treatment of abdominal aortic aneurysms. Results of a European multicenter registry. Eur J Vasc Endovasc Surg. 999;7: Zarins CK, White RA, Hodgson KJ, et al. for the AneuRx Clinical Investigators. Endoleak as a predictor of outcome after endovascular aneurysm repair: AneuRx multicenter clinical trial. J Vasc Surg. 000;:90 07.

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