throbber
J ENDOVASC THER
`2004;11:641–648
`
`lCLINICAL INVESTIGATION
`
`641
`
`l
`
`Endovascular Repair of Abdominal Aortic
`Aneurysms Using 3 Commercially Available Devices:
`Midterm Results
`
`Ali F. AbuRahma, MD; Patrick A. Stone, MD; Mark C. Bates, MD;
`Tariq N. Khan, MD; Jason M. Prigozen, MD; and Christine A. Welch, MS
`
`Vascular Center of Excellence and Department of Surgery, Robert C. Byrd
`Health Sciences Center of West Virginia University, Charleston, West Virginia,
`USA.
`
`l
`
`l
`
`Purpose: To report the early and midterm results of 3 commercially available stent-grafts
`for abdominal aortic aneurysm (AAA) exclusion.
`Methods: Since fall 1999, 151 patients (137 men; mean age 74 years, range 54–88) have
`undergone AAA repair using 88 Ancure, 46 AneuRx, and 17 Excluder stent-grafts in elective
`procedures. All patients were followed clinically and underwent postoperative duplex ul-
`trasound and/or computed tomographic angiography, which was repeated every 6 months.
`Results: The mean overall follow-up was 17 months (range 1–46). Initial technical failure
`was 3% (3/88) for Ancure versus 0% for AneuRx and Excluder. Primary endoleak occurred
`in 8% (7/88) of the Ancure patients versus 22% (10/46) for AneuRx and 6% (1/17) for Ex-
`cluder (p5NS). Early (30-day) graft thrombosis (2/151, 1%) was seen only in the Ancure
`group. The perioperative complication rates (excluding endoleak and fever) were 22% (19/
`88) for Ancure, 15% (7/46) for AneuRx, and 0% for Excluder (p5NS). There was only 1
`(0.7%) perioperative death in the series (Ancure patient). More ancillary procedures were
`performed in the Ancure group (p,0.05). Postoperatively, the size of the AAA decreased
`or remained unchanged in 76% for Ancure patients versus 75% for AneuRx and 64% for
`Excluder (p5NS). The incidences of late endoleak were 6% for Ancure, 2% for AneuRx,
`and 0% for Excluder (p5NS). The freedom from late endoleak at 3 years was 88% for
`Ancure and 97% for AneuRx (100% at 1 year for Excluder). Survival rates were similar. No
`AAA rupture was recorded.
`Conclusions: The Ancure device has slightly higher overall perioperative complications and
`early technical failure than AneuRx or Excluder. All 3 devices are effective in preventing
`aneurysm rupture; the overall midterm survival rates, freedom of endoleak, and limb pa-
`tency are somewhat similar.
`
`JEndovascTher2004;11:641–648
`
`Keywords:abdominal aortic aneurysm, endovascular repair, stent-graft, outcome analysis
`l
`l
`
`Abdominal aortic aneurysms (AAA) continue
`to be a leading cause of death in the United
`States. With the aging population and more
`
`liberal use of imaging techniques, AAA detec-
`tion appears to be on the rise. In addition to
`the apparent increased recognition, patients
`
`Presented at the International Congress XVII on Endovascular Interventions, Scottsdale, Arizona, USA,
`February 8–12, 2004.
`
`Address for correspondence and reprints: Ali F. AbuRahma, MD, Department of Surgery, WVU Phy-
`sicians of Charleston, 3100 MacCorkle Ave., SE, Charleston, WV 25304 USA. Fax: 1-304-556-3823; E-
`mail: ali.aburahma@camc.org
`
`Q 2004 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS
`
`Availableatwww.jevt.org
`
`TMT 2110
`Medtronic v. TMT
`IPR2021-01532
`
`

`

`642
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`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`J ENDOVASC THER
`2004;11:641–648
`
`have gained more knowledge and access to
`information on this disease. Patients desire a
`less invasive treatment, and advancements in
`technology have resulted in an increase in the
`use of these methods. Since the Food and
`Drug Administration (FDA) approved the An-
`cure and AneuRx devices for commercial use
`in September 1999, the trend to endovascular
`exclusion of AAA has escalated. Currently,
`over 50% of infrarenal AAAs at our institution
`are repaired by endovascular exclusion.
`Multiple publications have reported on the
`use of endovascular stent-graft devices for
`AAA repair.1–8 However, the majority of these
`studies were performed before the grafts
`were commercially available. Early and mid-
`term results have shown prevention of rup-
`ture, resistance to migration, and minimal
`preoperative morbidity and mortality in mul-
`tiple clinical trials, but long-term follow-up is
`lacking. Major disadvantages still remain: the
`high incidence of endoleak, ranging from 4%
`to 40% depending on device; patient selec-
`tion; length of follow-up2–8; expense of the de-
`vice; and postoperative surveillance, as well
`as high secondary procedure rates. However,
`most patients are willing to accept these dis-
`advantages in light of the shortened hospital
`stay and less invasive nature of the proce-
`dure. Since September 1999, we have used 3
`types of commercially prepared devices for
`endovascular AAA repair. Few reports have
`analyzed the results of these commercially
`manufactured stent-grafts since their approv-
`al.9–12
`
`METHODS
`Since fall 1999, 151 patients (137 men; mean
`age 74 years, range 54–88) have undergone
`AAA repair using 88 Ancure (Guidant Corpo-
`ration,
`Indianapolis,
`IN, USA), 46 AneuRx
`(Medtronic Corporation, Santa Rosa, CA,
`USA), and 17 Excluder (W. L. Gore and As-
`sociates, Flagstaff, AZ, USA) stent-grafts in
`elective procedures at our institution. Preop-
`erative workup included computed tomo-
`graphic angiography (CTA), color duplex ul-
`trasound, and arteriography to select patients
`for endovascular therapy. All efforts were
`made to follow the selection criteria recom-
`mended by the manufacturers. Device selec-
`
`tion was based on physician preference. All
`procedures were performed in the Circulatory
`Dynamics Laboratory under epidural or gen-
`eral anesthesia (based on physician’s choice)
`using conventional fluoroscopy (Advantx Im-
`aging System, General Electric Medical, Mil-
`waukee, WI, USA). All 3 devices were inserted
`and patients followed according to the man-
`ufacturer’s recommendations. Postoperative
`surveillance included plain abdominal radi-
`ography, CTA, and/or color duplex ultrasound
`at 1, 3, 6, and 12 months, then every 12
`months thereafter.
`The primary endpoints for analysis were
`technical success, death from aneurysm rup-
`ture or any other cause, surgical conversion,
`and secondary auxiliary procedures needed
`to insert the graft (e.g., balloon angioplasty of
`a native artery to facilitate graft insertion or
`treat endoleak) or to maintain graft patency
`(e.g., angioplasty and/or stenting for limb pa-
`tency after insertion). Late endoleak was de-
`termined using CT based on extravasation of
`contrast between the prosthesis and the an-
`eurysm wall and/or by color duplex ultra-
`sound if the flow and spectral signals were
`outside the prosthesis. If the CT and duplex
`results differed, contrast arteriography was
`done to confirm the endoleak. Primary or ear-
`ly endoleak was defined as a leak detected
`within 30 days of the procedure; secondary or
`late endoleak was defined as a leak observed
`.30 days postprocedurally.
`
`Statistical Analysis
`
`Demographic and clinical characteristics
`were analyzed using the chi-square or Fisher’s
`exact test. Similarly, the operative variables
`(operative time, blood loss, and blood trans-
`fusions) were also analyzed. Preoperative and
`postoperative AAA size at follow-up and the
`changes from pre to postoperative sizes were
`examined using paired ttests. In similar fash-
`ion, perioperative complications for the 3 de-
`vices were analyzed both with and without
`early endoleak and fever included as sequel-
`ae. Life-table analysis was used for overall
`survival, freedom from late endoleak, and
`freedom from late limb thrombosis; applica-
`tion of the log-rank test determined if there
`
`

`

`J ENDOVASC THER
`2004;11:641–648
`
`l
`
`Mean age, y (range)
`Men
`Hypertension
`Diabetes mellitus
`Hyperlipidemia
`Smoking
`Coronary artery disease
`COPD
`Chronic renal insufficiency
`l
`
`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`643
`
`l
`
`TABLE 1
`Demographics and Clinical Characteristics
`
`Ancure
`(n588)
`
`74 (54–86)
`82 (93%)
`65 (74%)
`22 (25%)
`57 (65%)
`69 (78%)
`70 (80%)
`46 (52%)
`14 (16%)
`
`AneuRx
`(n546)
`
`75 (58–85)
`41 (89%)
`34 (74%)
`9 (20%)
`21 (46%)
`34 (74%)
`32 (70%)
`20 (43%)
`9 (20%)
`
`Excluder
`(n517)
`
`73 (55–88)
`14 (82%)
`11 (65%)
`4 (24%)
`5 (29%)
`14 (82%)
`7 (41%)
`7 (41%)
`1 (6%)
`
`All Types
`(n5151)
`
`74 (54–88)
`137 (91%)
`110 (73%)
`35 (23%)
`83 (55%)
`117 (77%)
`109 (72%)
`73 (48%)
`24 (16%)
`
`p
`
`NS
`NS
`NS
`,0.01*
`NS
`,0.01*
`NS
`NS
`
`l
`
`NS: not significant, COPD: chronic obstructive pulmonary disease.
`* For Ancure patients.
`
`was any significance to the differences
`among the 3 devices.
`
`RESULTS
`The mean follow-up for the entire cohort was
`17 months (range 1–46); for the individual
`stent-grafts, the mean follow-up was 21
`months (range 1–46) for Ancure, 12 months
`(range 1–44) for AneuRx, and 6 months (range
`1–11) for Excluder. The technical success rate
`was 97% (85/88) for Ancure and 100% for the
`other 2 devices (98% for the entire cohort).
`The 3 failed Ancure cases included 2 failures
`to introduce the original model of this device;
`these were converted to AneuRx endografts
`in the same procedure. The other failure was
`due to iliac artery disruption; this patient un-
`derwent an open repair.
`Patients in all 3 endograft groups were
`comparable in terms of demographic and
`baseline characteristics (Table 1), except for
`the incidences of hyperlipidemia and coro-
`nary artery disease, which were significantly
`higher in the Ancure patients (p,0.001 and
`0.01, respectively). There were no significant
`differences in aneurysm size for the 3 device
`groups, whether preoperatively or at late fol-
`low-up. The percentage of patients who had
`similar or decreased sac sizes at midterm fol-
`low-up was 75.6% for Ancure, 76.1% for
`AneuRx, and 64.7% for the Excluder (p5NS).
`In terms of procedural variables, the mean
`blood loss for the Ancure patients was 319
`mL, in contrast to 193 mL for AneuRx and 163
`
`mL for Excluder (p,0.01). The mean operative
`time for the Ancure patients was also statis-
`tically significantly higher
`than for
`the
`AneuRx or Excluder: 3.2, 3.1, and 2.2 hours,
`respectively (p,0.001). Three quarters of the
`Ancure patients required auxiliary procedures
`to complete stent-graft insertion, in contrast
`to 26% for AneuRx and 24% for Excluder
`(p,0.05). The mean early (operative) ancillary
`procedures needed for the Ancure group was
`1.5% versus 0.4% for AneuRx and 0.3% for the
`Excluder (p,0.001). There were no significant
`differences among the 3 groups relative to
`time spent in the intensive care unit or hos-
`pital (Table 2).
`The perioperative complications are listed
`in Table 3. The incidence of postimplantation
`syndrome in our series was 23% for Ancure,
`28% for AneuRx, and 6% for Excluder; the fe-
`ver was reversed in less than a week in all of
`our patients. When all complications, includ-
`ing early endoleak and fever, were included
`(Table 4), the morbidity rates were 41% for
`Ancure, 48% for AneuRx, and 6% for Excluder
`(p50.01; Ancure vs. AneuRx: p50.4; Ancure
`vs. Excluder: p,0.01, AneuRx vs. Excluder:
`p,0.01). Similarly, when perioperative com-
`plications were compared without early en-
`doleak, the Excluder device had significantly
`fewer complications (p,0.05). Similar obser-
`vations were noted when fever or endoleak
`were excluded: 22% for Ancure, 15% for
`AneuRx, and 0% for Excluder.
`Primary (early) endoleak (Table 5) was not-
`ed in 8% in the Ancure group, in contrast to
`
`

`

`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`J ENDOVASC THER
`2004;11:641–648
`
`644
`
`l
`
`TABLE 2
`Number of Hospital Days
`
`Ancure
`(n588)
`
`AneuRx
`(n546)
`
`Excluder
`(n517)
`
`All Types
`(n5151)
`
`1.9864.78 (0–43) [1]
`3.5664.29 (1–30) [2]
`5.5566.48 (1–43) [4]
`NS
`
`1.4762.31 (0–15) [1]
`2.9362.42 (1–12) [3]
`4.4264.13 (1–27) [4]
`NS
`
`1.3360.72 (0–3) [1]
`1.8061.57 (1–5) [1]
`3.1363.13 (1–8) [2]
`NS
`
`1.7563.89 (0–43) [1]
`3.1863.62 (1–30) [2]
`4.9465.53 (1–43) [3]
`NS
`
`ICU, d
`Floor stay, d
`Total stay, d
`p
`l
`
`Data are presented as mean6standard deviation (range) [median]
`NS: not significant, ICU: intensive care unit.
`
`l
`
`l
`
`22% for the AneuRx and 6% for the Excluder
`groups (p50.07). Late endoleak was seen in
`6% in the Ancure group, 2% of the AneuRx
`patients, and none of
`the Excluder cases
`(p50.59), but the mean follow-up for the Ex-
`cluder was shorter. Most of the early endo-
`leaks sealed spontaneously (Table 6), includ-
`ing type I endoleaks. Of
`the 18 early
`endoleaks, only 2 persisted as late endoleaks
`at 28 and 3 months, respectively; both were
`in the Ancure group. The first patient refused
`any intervention, and the second is being fol-
`lowed. Of the 4 late endoleaks arising without
`an antecedent early leak, 2 were treated with
`proximal extension cuffs and the other 2 are
`being observed. Three of the late endoleaks
`
`were in the Ancure group. Notably, none of
`the type II endoleaks persisted as late endo-
`leaks.
`There was only 1 perioperative death in the
`entire series: an Ancure patient died second-
`ary to myocardial infarction. There were no
`statistically significant differences among the
`3 devices (p50.56, log-rank test) for overall
`survival (Fig. 1). None of the late deaths were
`aneurysm related. At 6, 12, 24, 36, and 42-
`month intervals, the freedom from late en-
`doleak (Fig. 2) was 97%, 97%, 88%, 88%, and
`88% for Ancure; 97%, 97%, 97%, 97%, and
`97% for AneuRx; and 100%, 100% and 100%
`for Excluder, respectively (p50.79). Freedom
`from late limb thrombosis (Fig. 3) at the same
`
`l
`
`Bleeding
`Major
`Minor
`Upper GI
`Colon ischemia
`Any bleeding
`MI
`Acute renal failure
`Wound infection
`Fever
`Vascular events
`Thrombosis
`Arterial disruption
`DVT
`All vascular events
`Early endoleak
`l
`
`TABLE 3
`Perioperative Complications
`
`Ancure
`(n588)
`
`AneuRx
`(n546)
`
`Excluder
`(n517)
`
`Total
`(n5151)
`
`3 (3%)
`6 (7%)
`0
`2 (2%)
`11 (13%)
`4 (5%)
`4 (5%)
`1 (1%)
`20 (23%)
`
`2 (2%)
`1 (1%)
`2 (2%)
`5 (6%)
`7 (8%)
`
`1 (2%)
`3 (7%)
`1 (2%)
`1 (2%)
`6 (13%)
`2 (4%)
`1 (2%)
`1 (2%)
`13 (28%)
`
`0
`0
`0
`0
`10 (22%)
`
`0
`0
`0
`0
`0
`0
`0
`0
`1 (6%)
`
`0
`0
`0
`0
`1 (6%)
`
`4 (3%)
`9 (6%)
`1 (1%)
`3 (2%)
`17 (11%)
`6 (4%)
`5 (3%)
`2 (1%)
`34 (23%)
`
`2 (1%)
`1 (1%)
`2 (1%)
`5 (3%)
`18 (12%)
`
`l
`
`l
`
`p
`
`NS
`0.78
`
`0.36
`NS
`NS
`NS
`NS
`
`NS
`NS
`NS
`NS
`NS
`
`NS: not significant, GI: gastrointestinal, MI: myocardial infarction, DVT: deep vein throm-
`bosis.
`
`

`

`J ENDOVASC THER
`2004;11:641–648
`
`l
`
`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`645
`
`l
`
`TABLE 4
`Comparison of Perioperative Complications Analyzed With/Without Fever and Early Endoleak
`
`All perioperative complications
`Without fever
`Without early endoleak
`Without fever or early endoleak
`l
`
`Ancure
`(n588)
`
`35 (40%)
`25 (28%)
`30 (34%)
`19 (22%)
`
`AneuRx
`(n546)
`
`22 (48%)
`14 (30%)
`17 (37%)
`7 (15%)
`
`Excluder
`(n517)
`
`1 (6%)
`1 (6%)
`1 (6%)
`0
`
`Total
`(n5151)
`
`58 (39%)
`40 (27%)
`48 (32%)
`26 (17%)
`
`p
`
`0.01*
`0.1
`,0.05†
`0.06‡
`
`l
`
`* AneuRx vs. Excluder: p,0.01; Ancure vs. AneuRx: NS; Ancure vs. Excluder: p,0.01.
`† AneuRx vs. Excluder: p,0.05; Ancure vs. AneuRx: NS; Ancure vs. Excluder: p,0.05.
`‡ AneuRx vs. Excluder: NS; Ancure vs. AneuRx: NS; Ancure vs. Excluder: p,0.05.
`
`intervals was 97%, 97%, 97%, 97%, and 97%
`for Ancure; 97%, 94%, 94%, 94%, and 94% for
`AneuRx; and 100%, 100%, and 100% for Ex-
`cluder, respectively (p50.59).
`
`DISCUSSION
`Despite the early success and benefits that
`have been reported for these endovascular
`grafts, great concern persists regarding their
`durability in the long run, the need for sec-
`ondary intervention, and the remote risk of
`rupture, even after exclusion.7,13,14 Previous
`reports on the use of these endografts in pro-
`spective multicenter studies have been limit-
`ed to a few groups of surgeons who were
`highly skilled in performing endovascular
`grafting in the pre-market era. Therefore,
`whether similar favorable results can be
`achieved with a broader application of these
`devices by a wide range of surgeons is not
`yet known. Our study analyzes our experience
`with 3 stent-grafts after their approval by the
`FDA; prior to that time, we had experience
`
`with a only few stented grafts on a compas-
`sionate use basis.
`
`Ancure
`In a 5-year comparison of this bifurcated
`device with open AAA repair, Moore et al.8 re-
`ported a 92.7% rate of successful implantation
`of the Ancure bifurcated endograft in 573 pa-
`tients, which is comparable to our 3.4% tech-
`nical failure rate in this subgroup. The com-
`bined major morbidity and mortality was
`44.1% in the open control cohort versus
`28.8% in the endograft group, which is in line
`with our complication rates. In terms of en-
`doleak, the incidences of early and late en-
`doleak in our study were 8% and 6%, respec-
`tively, with an 88% freedom from late
`endoleak at 36 months. Moore et al.8 reported
`74.4% of patients were free of endoleak at 60
`months in their series. The rate of endoleak
`at discharge was reported to range from 21%
`to 47% for the Ancure device; at 1 year it
`ranged between 6% and 29%.15–18 However,
`
`l
`
`Early
`Type I
`Type II
`Type III
`Type IV
`Total
`Late
`l
`
`TABLE 5
`The Frequency and Distribution of Endoleaks
`
`Ancure
`(n588)
`
`6 (7%)
`1 (1%)
`0
`0
`7 (8%)
`5 (6%)
`
`AneuRx
`(n546)
`
`3 (7%)
`5 (11%)
`0
`2 (4%)
`10 (22%)
`1 (2%)
`
`Excluder
`(n517)
`
`1 (6%)
`0
`0
`0
`1 (6%)
`0
`
`Total
`(n5151)
`
`10 (7%)
`6 (4%)
`0
`2 (1%)
`18 (12%)
`6 (4%)
`
`l
`
`l
`
`p
`
`NS
`NS
`NS
`NS
`0.07
`0.59
`
`NS: not significant.
`
`

`

`646
`
`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`l
`
`TABLE 6
`Fate of Early Endoleak and Timing of Late Endoleak
`
`J ENDOVASC THER
`2004;11:641–648
`
`l
`
`Patient
`
`Stent-Graft
`
`Type of Early
`Leak
`
`Type of Late
`Leak
`
`Time From
`Surgery to
`Late Leak, mo
`
`11
`25
`30
`47
`61
`69
`94
`104
`138
`145
`147
`6
`68
`75
`99
`120
`76
`100
`17
`21
`34
`103
`l
`
`Ancure
`Ancure
`Ancure
`Ancure
`Ancure
`AneuRx
`AneuRx
`Ancure
`Gore
`AneuRx
`AneuRx
`AneuRx
`AneuRx
`AneuRx
`Ancure
`AneuRx
`AneuRx
`AneuRx
`Ancure
`Ancure
`Ancure
`AneuRx
`
`I
`I
`I
`I
`I
`I
`I
`I
`I
`I
`I
`II
`II
`II
`II
`II
`IV
`IV
`None
`None
`None
`None
`
`I
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`I
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`Early seal
`I
`I
`I
`I
`
`28
`
`3
`
`25
`2
`27
`5
`
`l
`
`the majority of these endoleaks are clinically
`insignificant and do not require intervention
`since they are asymptomatic and seal spon-
`taneously.
`There were no early or late ruptures in our
`series. Similarly, Moore et al.8 reported no an-
`eurysm rupture in a 5-year follow-up of 573
`patients. On the other hand, Bernhard et al.19
`presented a collective series of 7 ruptured an-
`
`eurysms in patients with the Ancure endo-
`graft, but these all involved the tube graft.
`Graft limb stenosis or thrombosis is a widely
`recognized complication of the Ancure device
`because it
`lacks longitudinal stent sup-
`port.18,20 Two of our patients had periopera-
`tive limb thrombosis in the early stage of our
`experience with the Ancure device; thereafter,
`
`Figure 1lLife-table analysis of patient survival.
`
`Figure 2lLife-table analysis of freedom from late
`endoleak.
`
`

`

`J ENDOVASC THER
`2004;11:641–648
`
`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`647
`
`AneuRx stent-graft during all phases of the
`US clinical trials between 1996 and 1999. Ten
`(0.8%) patients had aneurysm rupture, but 6
`of these events occurred in the 174 (3.4%) pa-
`tients treated with the stiff bifurcated design
`used in phase I and the initial stages of phase
`II; however, when the new flexible design was
`introduced, only 4 (0.4%) ruptures occurred
`among 1018 patients. Patient survival rates
`were 91% at 1 year and 86% at 3 years. They
`also indicated that the freedom from aneu-
`rysm rupture with the commercially available
`segmented bifurcated stent-graft was 99.5%
`at 3 years.
`
`Excluder Device
`The Excluder bifurcated endograft has been
`widely used in Europe over the last several
`years. Although our experience with this graft
`is limited (we have implanted 15 more devic-
`es since this study was completed), we have
`had good initial success with it. Both the op-
`erative blood loss and operative time with
`this device were significantly less than for the
`other 2 devices in our hands.
`In the Gore phase II clinical study for the
`Excluder bifurcated endoprosthesis,21 the 3-
`year migration rate was ,1%, which repre-
`sented 1 patient in whom the device migrated
`intraoperatively. The cumulative endoleak
`rate for the Excluder device at 3 years was
`13%; the majority of these leaks were type II.21
`To date, the worldwide rupture rate for the Ex-
`cluder bifurcated graft has been reported to
`be 0.5% (4/8500 cases).22
`Bertges et al.23 reported that aneurysm size
`regression 2 years after endovascular repair
`was not significantly different between the
`Excluder and the AneuRx stent-grafts: 53% of
`the Excluder patients showed no change at 2
`years compared to 52% for the AneuRx graft,
`while 3% increased in the Excluder group (.5
`mm) versus 2% for the AneuRx graft.
`In conclusion, the Ancure device has slight-
`ly higher overall perioperative complications
`and early technical failure than AneuRx or Ex-
`cluder. All 3 devices are effective in prevent-
`ing aneurysm rupture at midterm. The overall
`3-year survival rates, freedom of endoleak,
`and limb patency are somewhat similar.
`It
`should be noted that the Ancure device was
`
`Figure 3lLife-table analysis of freedom from late
`limb thrombosis.
`
`we routinely inserted Wallstents in all the An-
`cure stent-grafts, which explains the high in-
`cidence (74%) of auxiliary procedures in this
`group. Thus, the high (97%) freedom from
`late limb thrombosis in our series can be at-
`tributed to the stenting that was done rou-
`tinely in most of our patients. Moore et al.8
`reported a 95% freedom from graft thrombo-
`sis at 12 months.
`The 5.6-day mean hospital stay in our pa-
`tients with the Ancure graft was somewhat
`longer than we currently experience, but in
`the early days of our endograft program, we
`were reluctant to discharge these patients
`earlier. Previous studies have reported a
`mean operative time for the Ancure device
`ranging from 130 to 211 minutes,17–19 with
`mean blood loss between 300 and 498 mL
`and a mean hospital stay of 3 to 4 days; all
`these outcomes are is in line with our expe-
`rience.
`Despite the favorable results with the An-
`cure device, it was withdrawn from the mar-
`ket in October 2003 due to difficulties with the
`Department of Justice. The data presented
`here are critical since several thousand An-
`cure stent-grafts have been implanted world-
`wide; however the long-term outcome of
`these devices is still in question.
`
`AneuRx
`Zarins et al.7 examined the outcomes of
`1192 patients who were treated with the
`
`

`

`648
`
`AAA REPAIR WITH COMMERCIAL ENDOGRAFTS
`AbuRahma et al.
`
`J ENDOVASC THER
`2004;11:641–648
`
`placed earlier in our experience and the Ex-
`cluder device later, which may partially ex-
`plain some of these differences.
`
`REFERENCES
`1. Parodi JC, Ferreira M. Ten-year experience with
`endovascular therapy in aortic aneurysms. J
`AmCollSurg. 2002;194:58–S66.
`2. Moore WS, Rutherford RB. Transfemoral en-
`dovascular repair of abdominal aortic aneu-
`rysm: results of the North American EVT phase
`1 trial. JVascSurg. 1996;23:543–553.
`3. Malina M, Ivancev K, Chuter TAM, et al. Chang-
`ing aneurysmal morphology after endovascu-
`lar grafting: relation to leakage or persistent
`perfusion. JEndovascSurg. 1997;4:23–30.
`4. White GH, Yu W, May J, et al. Endoleak as a
`complication of endoluminal grafting of ab-
`dominal aortic aneurysms: classification, inci-
`dence, diagnosis, and management. J Endo-
`vascSurg. 1997;4:152–168.
`5. May J, White G, Yu W, et al. Concurrent com-
`parison of endoluminal versus open repair in
`the treatment of abdominal aortic aneurysms:
`analysis of 303 patients by life table method. J
`VascSurg. 1998;27:213–221.
`6. Matsumura JS, Moore WS. Clinical conse-
`quences of periprosthetic leak after endovas-
`cular repair of abdominal aortic aneurysm. J
`VascSurg. 1998;27:606–613.
`7. Zarins CK, White RA, Moll FL, et al. The
`AneuRx stent graft:
`four-year results and
`worldwide experience 2000. JVascSurg.2001;
`33:S135–145.
`8. Moore WS, Matsumura JS, Makaroun MS, et
`al. Five-year interim comparison of the Guidant
`bifurcated endograft with open repair of ab-
`dominal aortic aneurysm. JVascSurg.2003;38:
`46–55.
`9. Naslund RC, Becker SY. Technical success from
`endovascular aneurysm repair in the post-mar-
`keting era: a multicenter prospective trial. Ann
`VascSurg. 2003;17:35–42.
`10. Ramaiah VG, Westerband A, Thompson C, et
`al. The AneuRx stent-graft since FDA approval:
`single-center experience of 230 cases. J En-
`dovascTher. 2002;9:464–469.
`11. Sanchez LA, Rubin BG, Keller CA, et al. Endo-
`vascular repair of abdominal aortic aneurysms
`in women after FDA approval: results, compli-
`
`cations, and limitations. AnnVasc Surg. 2002;
`16:430–435.
`12. Adelman MA, Rockman CB, Lamparello PJ, et
`al. Endovascular abdominal aortic aneurysm
`(AAA) repair since the FDA approval. Are we
`going too far? J Cardiovasc Surg (Torino).
`2002;43:359–367.
`13. Alimi YS, Chakfe N, Rivoal E, et al. Rupture of
`an abdominal aortic aneurysm after endovas-
`cular graft placement and aneurysm size re-
`duction. JVascSurg. 1998;28:178–183.
`14. Collin J, Murie JA. Endovascular treatment of
`abdominal aortic aneurysm: a failed experi-
`ment. BrJSurg. 2001;88:1281–1282.
`15. Moore WS, Brewster DC, Bernhard VM. Aorto-
`uni-iliac endograft for complex aortoiliac an-
`eurysms compared with tube/bifurcation en-
`dografts: Results of the EVT/Guidant trials. J
`VascSurg. 2001;33:S11–20.
`16. Brewster DC, Geller SC, Kaufman JA, et al. Ini-
`tial experience with endovascular aneurysm
`repair: comparison of early results with out-
`come of conventional open repair. JVascSurg.
`1998;27:992–1005.
`17. Moore WS, Kashyap VS, Vescera CL, et al. Ab-
`dominal aortic aneurysm: a 6-year comparison
`of endovascular versus transabdominal repair.
`AnnSurg. 1999;230:298–308.
`18. Makaroun MS. The Ancure endografting sys-
`tem: an update. J Vasc Surg. 2001;33:S129–
`134.
`19. Bernhard VM, Mitchell RS, Matsumura JS, et
`al. Ruptured abdominal aortic aneurysm after
`endovascular repair. J Vasc Surg. 2002;35:
`1155–1162.
`20. Carpenter JP, Neschis DG, Fairman RM, et al.
`Failure of endovascular abdominal aortic an-
`eurysm graft limbs. JVascSurg. 2001;33:296–
`303.
`21. Matsumura JS, Brewster DC, Makaroun MS, et
`al. A multicenter controlled clinical trial of open
`versus endovascular treatment of abdominal
`aortic aneurysm. J Vasc Surg. 2003;37:262–
`271.
`22. Kibbe MR, Matsumura JS, for the Excluder In-
`vestigators. The Gore excluder US multi-center
`trial: analysis of adverse events at 2 years.
`SeminVascSurg. 2003;16:144–150.
`23. Bertges DJ, Chow K, Wyers MC, et al. Abdom-
`inal aortic aneurysm size regression after en-
`dovascular repair is endograft dependent. J
`VascSurg. 2003;37:716–723.
`
`

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