Endotension after endovascular aneurysm repair: the Ancure experience. 2001

G H Meier, and F M Parker, and V Godziachvili, and R J Demasi, and F N Parent, and R G Gayle
Eastern Virginia Medical School, Norfolk Surgical Group, VA 23510, USA. ghm3@aol.com

OBJECTIVE The expansion of aneurysms after endovascular repair is a consequence of persistent sac pressure, usually resulting from an endoleak. Several authors have suggested that sac expansion can occur even in the absence of endoleak, referring to this phenomenon as endotension. This study undertakes a review of the largest US endograft trial data to better define the significance of aneurysm expansion in the absence of endoleak. METHODS The core laboratory imaging database from the Ancure (Guidant) endovascular graft Phase I and Phase II trials approved by the Food and Drug Administration was reviewed with attention to aneurysm size and endoleak. Aneurysm size was measured with standardized two-dimensional computed tomography (CT) scan at the area of largest initial aneurysm diameter. Endoleak was detected with CT scans, color duplex ultrasound scans, and angiography in selected cases. Patients were evaluated at baseline, 3 months, 6 months, 12 months, and every 12 months thereafter. An endograft was classified as leaking if any endoleak was detected with any modality at any time point. RESULTS A total of 658 patients were entered into these protocols and the data submitted to the core laboratory. A control group of 120 conventional aortic patients and a group of 62 without baseline CT data were excluded from further analysis. Of the remaining 476 patients, 144 (60 tube, 60 bifurcated, and 24 mono-iliac) were free of endoleak at all intervals and had baseline CT measurements to allow comparison. Overall, the average size decrease in this nonleaking group was 9.9 +/- 9.4 mm (range, -50.6-11.1 mm) at a mean follow-up of 23.3 months. Evaluation for overall aneurysm expansion revealed 17 patients who had an increase of 2.3 +/- 2.9 mm (range, 0.3-11.1 mm) at a mean follow-up of 14.1 months. Only two patients without evidence of endoleak exhibited growth of more than 5 mm at maximum follow-up (7.6 mm at 12 months and 11.1 mm at 36 months). Additional analysis of sealed endoleaks and late endoleaks failed to demonstrate any group with expansion in the absence of detectable endoleak. CONCLUSIONS Endotension appears to be rare in this large series of prospectively evaluated endografts. From this review, endotension seems more likely to represent missed endoleak than true aneurysm expansion in the absence of perigraft flow.

UI MeSH Term Description Entries
D011183 Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery. Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D011312 Pressure A type of stress exerted uniformly in all directions. Its measure is the force exerted per unit area. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Pressures
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D015607 Stents Devices that provide support for tubular structures that are being anastomosed or for body cavities during skin grafting. Stent
D017544 Aortic Aneurysm, Abdominal An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm. Abdominal Aorta Aneurysm,Aneurysm, Abdominal Aorta,Abdominal Aortic Aneurysm,Aneurysm, Abdominal Aortic,Abdominal Aorta Aneurysms,Abdominal Aortic Aneurysms,Aorta Aneurysm, Abdominal

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