Experience and Outcomes After a Decade of Endovascular Abdominal Aortic Aneurysm Repair: A Retrospective Study From a Community-Based Single Center

doi:10.1016/j.avsg.2011.06.012

Annals of Vascular Surgery

Volume 26, Issue 3, April 2012, Pages 330-337

https://doi.org/10.1016/j.avsg.2011.06.012 Get rights and content

Background

The purpose of this study is to report the results of endovascular abdominal aortic aneurysm treatment based on the Zenith stent–graft from a community-based single center over a period of 9 years.

Methods

We retrospectively analyzed immediate technical and clinical results as well as long-term outcomes in patients treated with endovascular aneurysm repair between 2001 and 2010. The study was performed in accordance with the recommendations of the ad hoc committee for standardized reporting practice in vascular surgery.

Results

A total of 106 patients were treated in a period of 9 years. A Zenith stent–graft was used in 95% of cases. No deaths occurred during the first 30 days postsurgery. The complication rate was 4.7% (n = 5). The overall clinical and technical success rate at 30 days was 93.4%. After a mean follow-up period of 52 months (range, 13–112 months), the overall mortality rate was 25.4%. Aneurysm-related mortality was 2.1%. Rupture of the aneurysm occurred in four cases (4.3%). The final clinical failure rate was 13.8%. During the follow-up period, the mean diameter of the aneurysm decreased from 58.0 to 52.3 mm. However, expansion of the aneurysm was registered in 10 cases. Eleven patients had a primary endoleak, and another 11 secondary endoleaks occurred during the follow-up. The reintervention rate was 16.3%. The main reasons for repeat interventions were iliac limb occlusion (n = 5) and type 3 endoleak/limb disconnection (n = 4). Graft migration occurred in 3% of cases. A negative impact on sexual function after endovascular repair was reported by 20% of patients.

Conclusion

Endovascular repair is the treatment of choice for high-risk patients. A small but significant number of clinical failures were observed during the long-term follow-up.

Introduction

Endovascular repair of infrarenal aortic aneurysms by the use of a stent–graft (EVAR) was originally introduced as an alternative to open surgery for high-risk patients. Over the last 15 years, this therapy has become the standard treatment procedure for infrarenal aortic aneurysms at many centers.1, 2 The method was introduced at our vascular center in 1997 and is being frequently used since 2001.

Distal stent–graft migration was identified as a specific problem associated with early use of the EVAR technique.3, 4 At our institution, the Zenith stent–graft (Cook Corporation, Indianapolis, IN) was the device of choice since 2001 because the special design of this stent–graft and its stable fixation in the aorta render it especially resistant to distal migration.

A large number of studies have been published to date about short- and midterm outcomes of EVAR. However, data concerning long-term results are scarce and are largely derived from specialized academic centers with very large case numbers, or the studies were performed as multicenter trials with selective patient inclusion criteria.

The aim of the present study is to report clinical long-term results and technical success rates after EVAR, based on routine clinical use at a non–university-based vascular center.

Section snippets

Patients, Materials, and Method

The study was approved by the local ethics committee. Between January 2001 and January 2010, 144 patients underwent elective treatment for abdominal aortic aneurysms (AAAs) at our vascular centre. Of these patients, 38 were treated by open repair, and 106, by EVAR. We retrospectively collected the data of all EVAR patients on an intention to treat basis. Patients with a ruptured aortic aneurysm or an isolated iliac artery aneurysm were excluded. For data collection, the patients’ medical files,

Results

In the observation period, 106 elective EVAR procedures were performed at our vascular center. The patients’ mean age was 72 years (range, 36–87 years). Table I provides a detailed account of demographic data and comorbidities. Anatomical details of the treated aneurysms are shown in Table II.

The Zenith stent–graft, used as the device of first choice at our interventional radiology department, was applied in 95% of cases. Five patients with very narrow iliac vessels were treated with a Gore

Technical Outcome and 30-Day Results

Two procedures had to be abandoned due to difficult anatomy. One was converted to open repair, the other, to conservative management, as the patient was not eligible for open surgery. Follow-up was uneventful in both patients.

The technical and clinical success rate at the time of discharge from the hospital and after 30 days was 93.4%.

In addition to the two conversion cases, technical failure was caused by an endoleak type 1 or 3 in five cases. One type 3 endoleak was treated by balloon

Discussion

The importance of the evaluation presented here is the fact that it is based on long-term results obtained from clinical routine at a hospital with a moderate patient frequency. All patients treated during the preceding 9 years were included. Thus, the situation in the real world—in contrast to that encountered in highly specialized centers and clinical trials—is presented here.

The long-term outcomes reported in the published literature are heterogeneous in respect of the type and intensity of

Conclusion

EVAR is the optimal modality for the management of AAA, especially in patients with suitable anatomical conditions and a high surgical risk. However, the favorable initial success rates and low procedural morbidity and mortality should be balanced against the overall increase in mortality, reinterventions, and clinical failure rates in the long-term follow-up. The results of routine operation at a community hospital may be compared with those from academic centers involving large case numbers.

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Cited by (9)

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients
2022, Annals of Vascular Surgery
Citation Excerpt :
Despite the presence of hostile iliac anatomy, the limb occlusion rate is comparable to results in other contemporary cohorts like the ENGAGE registry with 1.1%.6,7,11–13 However, since limb occlusions are usually observed outside the 30-day time window following the index procedure, a longer follow up period must be awaited for more definitive conclusions.8,14–17 The ZEPHYR registry is a physician initiated multicenter trial with core lab-controlled image-based follow-up investigating the technical and clinical performance of the Zenith Alpha Abdominal Endovascular in the elective endovascular treatment of AAA.
To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR).
Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported).
Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion.
Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0–79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0–63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0–25.2) with a median proximal neck length of 24.4 mm (IQR 15.0–34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0–35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1–19.4) and 16.2 mm (IQR 14.1–19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1).
Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.
Predisposing Factors for Migration of the Iliac Limb and Reintervention after Endovascular Abdominal Aortic Aneurysm Repair
2019, Annals of Vascular Surgery
Citation Excerpt :
Migration of the iliac limb always results in type 1b and type 3 endoleaks that need reintervention. For type 1b endoleak caused by distal limb migration, the most common reintervention procedure is implantation of additional iliac extension.11,13,15 Mallios et al.16 reported that one patient with type 1b endoleak and “running stent” was successfully treated endovascularly to preserve IIA using a branched iliac device.
Migration of the iliac limb after endovascular abdominal aortic aneurysm repair (EVAR) can result in type 1b and 3 endoleaks, which are relatively common causes of reintervention after EVAR. The aim of the present study was to investigate the factors influencing migration of the iliac limb and methods of treatment.
From April 2012 to September 2017, 4 patients experienced migration of the iliac limb, requiring additional iliac stent graft implantation intraoperatively or at follow-up at our institute. Patient 1 was a 74-year-old man in whom preoperative computed tomography angiography (CTA) revealed a large aneurysm. The patient underwent EVAR with a bifurcated stent graft, and the left iliac stent graft migrated into the aneurysm sac. Patient 2 was a 53-year-old man in whom CTA revealed a large abdominal aortic aneurysm (AAA) involving the bilateral common iliac artery (CIA), with occlusion of the left hypogastric artery. An iliac stent graft was deployed to the right CIA to preserve the hypogastric artery. CTA, at 5 years of follow-up, showed migration of the right iliac limb and impending rupture. Patient 3 was a 61-year-old man with a ruptured AAA, and CTA revealed a large AAA and dilated CIA. The patient underwent EVAR with a bifurcated stent graft. Three years after EVAR, CTA showed that the right iliac limb migrated and kinked, with rupture of the stent graft. Patient 4 was an 80-year-old man with a ruptured AAA and aortocaval fistula. CTA revealed a large aneurysm involving the bilateral CIA. The patient underwent urgent EVAR with a bifurcated stent graft, and a cuff was deployed to seal the landing zone of the left CIA to preserve the hypogastric artery. Type 3 endoleak occurred because of the migration and detachment of the left iliac limb. All 4 patients underwent additional iliac stent graft implantation to connect or reline the iliac limb.
The mean diameter of the aneurysms was 85.3 ± 18.9 mm, and 2 patients were diagnosed with ruptured AAAs. The mean diameter, length, and proportional engagement rate of the CIA that experienced migration of the iliac limb were 25.50 ± 11.1 mm, 32.8 ± 6.6 mm, and 72.75% ± 17.88%, respectively. Oversizing of the iliac stent graft was 10–20% in 2 patients and was less than 10% in the other 2 patients. The migrated iliac limbs were bell-bottom stent grafts. All patients underwent additional iliac stent graft implantation successfully, and there were no deaths or complications perioperatively. The patients were followed up from 7 months to 3 years and remained in good condition.
Migration of the iliac limb after EVAR was influenced by a complex combination of several factors including a large aneurysm (>60 mm in diameter), dilated or aneurysmal CIA (>18 mm in diameter), short length of fixation (<70%), lower degree of iliac limb oversizing (<10–20%), and bell-bottom of the iliac limb. Patients with these factors require more vigorous surveillance after EVAR. The implantation of an additional stent graft is effective and is the most common reintervention procedure.
A decade of outcomes and predictors of sac enlargement after endovascular abdominal aortic aneurysm repair using zenith endografts in a Japanese population
2014, Journal of Vascular and Interventional Radiology
Citation Excerpt :
Most deaths were unrelated to aneurysms. This finding is comparable to previously reported aneurysm-related mortality rates of 0.7%–7% (1–3,14–17). We evaluated the impact of proximal neck anatomic features on the initial technical success and sac enlargement after EVAR.
To present 10-year outcomes and risk factors for sac enlargement after endovascular aneurysm repair (EVAR) using the Zenith AAA Endovascular Graft (Cook, Inc, Bloomington, Indiana) in a Japanese population.
During the period 1999–2011, 127 patients underwent elective EVAR using Zenith endografts at a single institution. A retrospective investigation looked at initial rates of technical success and complications, 10-year rate of freedom from all-cause and aneurysm-related mortality, freedom from secondary intervention and sac enlargement, and risk factors for second intervention and sac enlargement.
The median age of the patients was 78 years, and the median follow-up time was 43 months. The initial technical success rate was 98.4% (125 of 127 patients). Major adverse events occurred in 7 of 127 (5.5%) patients. Rates of freedom from all-cause and aneurysm-related mortality at 1, 3, 5, and 10 years were 95%, 87%, 77%, and 39% (all-cause mortality) and 100%, 100%, 99%, and 93% (aneurysm-related mortality). Rates of freedom from secondary intervention at 1, 3, 5, and 10 years were 97%, 91%, 88%, and 70%. Rates of primary freedom from sac enlargement at 1, 3, 5, and 10 years were 99%, 87%, 75%, and 67%. Multivariate analysis revealed aneurysm sac diameter as an independent risk factor for a secondary intervention. Preoperative sac diameter combined with an angulated short (AS) proximal neck was a risk factor for sac enlargement.
The 10-year results of EVAR using Zenith endografts in a Japanese population were comparable to results from Western countries. Larger aneurysms and AS neck were predictors of sac enlargement after EVAR.
Costs of endovascular and open repair of thoracic aortic aneurysms
2024, British Journal of Surgery
Systematic review of endovascular stent grafting versus open surgical repair for the elective treatment of arch/descending thoracic aortic aneurysms
2021, BMJ Open
Clinical impact of hypogastric artery occlusion in endovascular aneurysm repair
2015, Vascular

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Clinical ResearchExperience and Outcomes After a Decade of Endovascular Abdominal Aortic Aneurysm Repair: A Retrospective Study From a Community-Based Single Center

Background

Methods

Results

Conclusion

Introduction

Section snippets

Patients, Materials, and Method

Results

Technical Outcome and 30-Day Results

Discussion

Conclusion

J Vasc Surg

Eur J Vasc Endovasc Surg

J Vasc Interv Radiol

J Vasc Surg

J Vasc Surg

J Vasc Surg

J Vasc Surg

J Vasc Surg

Clinical Research
Experience and Outcomes After a Decade of Endovascular Abdominal Aortic Aneurysm Repair: A Retrospective Study From a Community-Based Single Center