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Evidence - Endovascular bifurcation prosthesis for infrarenal AAA with simultaneous aneurysm of the right common iliac artery (EVAR with iliac sidebranch)

  1. Summary of the Literature

    Aneurysmal Diseases of the Aortoiliac Vascular Segment

    1. Abdominal Aortic Aneurysm

    The permanent expansion of the vessel diameter to 1.5 times the norm is defined as an aneurysm. The average transverse diameter of the healthy infrarenal aorta is approximately 1.93 cm in men and approximately 1.67 cm in women [1]. From a diameter of 3.0 cm, an abdominal aortic aneurysm (AAA) is present according to international consensus.

    Epidemiology and Etiology

    The most common location of aortic aneurysms is the abdominal aortic segment with 40 – 60 %, with the renal artery origins involved in 5 % of cases.

    Population-based studies showed a prevalence of AAA of 4 to 7.6 % in the group of men over 50 years old and about 1.3 % in women of the same age [2, 3]. Men are affected significantly more often in a ratio of 6:1. According to larger international registry studies, the perioperative overall mortality is between 1.6 % for intact AAA (iAAA) and 31.6 % for ruptured AAA (rAAA) [4]. With a lethality of up to 90 %, the prognosis of rAAA is particularly poor, so effective strategies for elective treatment in the non-ruptured stage are required [5].

    The most important risk factors for the development of AAA are smoking, positive family history, age, and atherosclerosis. The most significant risk factor with an odds ratio of 5.07 is nicotine consumption [3].

    Diagnostics       

    The AAA is often discovered as an incidental finding during routine examinations or as part of screening programs and not infrequently remains clinically silent until rupture. In the presence of a 3 cm AAA, the clinical examination provides indications of the presence of an AAA in only 29 % [6]. The gold standard for diagnostics and therapy planning of AAA is contrast-enhanced spiral computed tomography (sensitivity 93-100 %, specificity up to 96 %). Considering the high radiation dose of a CT (27.4 mSV for three phases, X-ray abdominal overview for comparison: about 2 mSv), the MRI examination represents an equivalent alternative, especially in postoperative follow-up with a sensitivity of 96 % and specificity of up to 100 % [7, 8]. For initial and screening examinations of the abdominal aorta, color-coded duplex sonography can be considered, which, depending on the examiner's experience, has a sensitivity or specificity of up to 100 % [9].

    Therapy

    In addition to conservative or medical treatment to optimize risk factors, open aortic replacement (“open aortic repair” OAR) and the endovascular procedure (“endovascular aortic repair”, EVAR) are available for invasive therapy of AAA. The approach should be chosen individually and take into account the patient's individual circumstances (comorbidities, life expectancy, patient preference).

    The indication is basically based on the existing rupture risk. This is less than 1 % per year for AAA with a diameter of 4.4 cm and increases significantly from 5 cm. From an AAA diameter of over 5 cm, the annual rupture risk is about 11 % [10, 11]. In elective treatment of an AAA, the individual rupture risk is contrasted with a 30-day mortality of about 1.8 % for EVAR and 4.3 % for OAR [12]. However, the “EVAR early advantage” levels off in the long-term course, so that both procedures have equivalent long-term outcomes [13]. It follows that the elective surgical risk for AAA < 5 cm is higher than the annual rupture risk, which is why an indication for aneurysm exclusion applies only from 5 – 5.5 cm. Small aneurysms < 5 cm have an average annual growth rate of about 0.21 cm, which is why duplex sonographic follow-up checks should be performed at 6- or 12-month intervals [11, 14]. Symptoms attributable to an AAA as well as rapid size progression over 0.5 cm in 6 months are associated with a significantly increased risk of rupture and therefore represent an absolute indication for treatment.

    For a long time, open surgical aortic replacement according to Creech represented the standard therapy for AAA [15], for which - partially coated - tube and Y-prostheses made of Dacron or PTFE are available. In three larger randomized studies, the 30-day mortality was reported as 3.0 % (OVER, USA), 4.3 % (EVAR-1, UK) and 4.6 % (DREAM, Netherlands). Mortality, revision rate, and lethality are significantly lower when the procedure is performed in specialized vascular surgery centers: The perioperative mortality is about 2.2 % for vascular surgeons, 4.0 % for cardiac surgeons, and 5.5 % for general surgeons. [16, 17]. Of particular importance for perioperative mortality are primarily cardiopulmonary complications, renal insufficiency, bleeding complications, and infections.

    After the initial description of the procedure in 1988 by Nikolay Volodos [18], there was a continuous increase in EVAR procedures worldwide. In 2010, the EVAR share in the USA was 74 % [19] and in 2012 in Germany about 73 % [20]. Whether an EVAR can be performed depends, among other things, on the anatomical conditions and the morphology of the AAA as well as the access vessels. For complex anatomical conditions, so-called “custom-made” endografts with fenestrations and cutouts, e.g., for the visceral vessel origins, are now available. Their use should be reserved for specialized centers, as the mortality rate correlates significantly with the number of treated cases [17, 21].

    2. Iliac Aneurysm

    Iliac aneurysms can occur in the area of all pelvic vessels, but in most cases the common iliac artery is affected. There is very often an association with abdominal aortic aneurysms. About 16–20 % of patients with abdominal aneurysm also have an iliac aneurysm [22, 23]. Isolated iliac aneurysms are significantly rarer (2 %) and then usually affect the common iliac artery [24].

    Regarding the rupture risk of iliac aneurysms, the data in the literature are variable [25]. McCready et al. were able to determine in their analysis that the average diameter of both symptomatic and ruptured iliac aneurysms was 7.8 cm [24]. Huang et al. observed a median diameter of ruptured iliac aneurysms of 6 cm and Lowry et al. of 7.5 cm. However, in all publications, it was observed that the range in the size of ruptured aneurysms is large (3.5–18 cm), but a rupture rarely occurs < 4 cm [26, 27].

    In contrast to AAA, iliac aneurysms more frequently cause clinical symptoms. Symptoms are observed in over 60 % of patients [28]. Pain due to compression of adjacent structures is most commonly reported. In particular, the symptomatic internal iliac artery aneurysm often shows signs of a neurological compression syndrome with lumbosacral pain or sciatica (18 %), abdominal complaints (32 %), groin pain (12 %), hip and buttock complaints (8 %), urogenital complaints up to congestion-related renal failure (28 %).

    The analysis of the current literature suggests that the rupture risk for smaller aneurysms can be classified as extremely low. Only when exceeding the 3 cm limit does the rupture risk seem to increase significantly [29].

    Surgical therapy represented the “gold standard” in the treatment of iliac aneurysms in the past. It is performed depending on the location (aorta, common iliac artery, external and internal) by interposition of a vascular prosthesis, preferably by aorto-(bi)iliac reconstruction ± revascularization (or ligation) of the internal iliac artery via a retro- or transperitoneal approach. In the treatment of iliac aneurysms, endovascular techniques have gained increasing importance in recent decades. While in the past complex aortoiliac aneurysms in rupture were almost exclusively treated openly, an endovascular approach is now increasingly chosen even in emergency care [27, 29].

  2. Currently ongoing studies on this topic

  3. Literature on this topic

    1. Rogers IS et al. Distribution, determinants, and normal reference values of thoracic and abdominal aortic diameters by computed tomography (from the Framingham Heart Study). Am J Cardiol. 2013;111:1510–6.

    2. Guirguis-Blake JM et al. Ultrasonography screening for abdominal aortic aneurysms: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2014;160:321–9.

    3. Lederle FA et al. The aneurysm detection and management study screening program: validation cohort and final results. Aneurysm Detection and Management Veterans Affairs Cooperative Study Investigators. Arch Intern Med. 2000;160:1425–30.

    4. Mani K et al. Treatment of abdominal aortic aneurysm in nine countries 2005-2009: a vascunet report. Eur J Vasc Endovasc Surg. 2011;42:598–607.

    5. Fleming C et al. Screening for abdominal aortic aneurysm: a best-evidence systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2005;142:203–11.

    6. Lederle FA et al. The rational clinical examination. Does this patient have abdominal aortic aneurysm? JAMA. 1999;281:77–82.

    7. Buffa V et al. Dual-source dual-energy CT: dose reduction after endovascular abdominal aortic aneurysm repair. Radiol Med. 2014 Jul 2.

    8. Cantisani V et al. Prospective comparative analysis of colour-Doppler ultrasound, contrast-enhanced ultrasound, computed tomography and magnetic resonance in detecting endoleak after endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2011;41:186–92.

    9. LeFevre ML; U.S. Preventive Services Task Force. Screening for abdominal aortic aneurysm: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161:281–90.

    10. Scott RA et al. Abdominal aortic aneurysm rupture rates: a 7-year follow- up of the entire abdominal aortic aneurysm population detected by screening. J Vasc Surg. 1998;28:124–8.

    11. Reed WW et al. Learning from the last ultrasound. A population-based study of patients with abdominal aortic aneurysm. Arch Intern Med. 1997;157:2064–8.

    12. Greenhalgh RM et al. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010;362:1863–71.

    13. Lederle FA et al. Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm. N Engl J Med. 2012:36:1988-97.

    14. Moll FL et al. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011;41 Suppl 1:S1–S58.

    15. Creech O Jr. Endo-aneurysmorrhaphy and treatment of aortic aneurysm. Ann Surg. 1966;164:935–46.

    16. Hawkins AT et al. The effect of surgeon specialization on outcomes after ruptured abdominal aortic aneurysm repair. J Vasc Surg. 2014;60:590–6.

    17. Dimick JB et al. Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the United States. J Vasc Surg. 2003;38:739–44.

    18. Volodos NL et al. A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988;(6):84–6.

    19. Dua A et al. Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010. J Vasc Surg. 2014;59:1512–7.

    20. Debus ES et al. On the treatment of abdominal aortic aneurysm in Germany. Gefässchirurgie. 2014;19:412–21.

    21. Holt PJ et al. Effect of endovascular aneurysm repair on the volumeoutcome relationship in aneurysm repair. Circ Cardiovasc Qual Outcomes. 2009;2:624–32.

    22. Armon MP et al. Common iliac artery aneurysms in patients with abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 1998;15:255–257.

    23. Brunkwall J et al. Solitary aneurysms of the iliac arterial system: an estimate of their frequency of occurrence. J Vasc Surg 1989;10:381–384.

    24. McCready RA et al. Isolated iliac artery aneurysms. Surgery 1983;93:688–693

    25. Richardson JW et al. Natural history and management of iliac aneurysms. J Vasc Surg 1988;8:165–171.

    26. Lowry SF et al. Isolated aneurysms of the iliac artery. Arch Surg 1978;113:1289–1293.

    27. Huang Y et al. Common iliac artery aneurysm: expansion rate and results of open surgical and endovascular repair. J Vasc Surg 2008;47:1203–1211.e2.

    28. Krupski WC et al. Contemporary management of isolated iliac aneurysms. J Vasc Surg 1998;28:1–13.

    29. Laine MT et al. Few internal iliac artery aneurysms rupture under 4 cm. J Vasc Surg 2017;65:76–81.

  4. Reviews

    Altobelli E, Rapacchietta L, Profeta VF, Fagnano R. Risk Factors for Abdominal Aortic Aneurysm in Population-Based Studies: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2018 Dec 10;15(12).

    Bergqvist D, Mani K, Troëng T, Wanhainen A. Treatment of aortic aneurysms registered in Swedvasc: Development reflected in a national vascular registry with an almost 100% coverage. Gefasschirurgie. 2018;23(5):340-345.

    Charisis N, Bouris V, Rakic A, Landau D, Labropoulos N. A systematic review on endovascular repair of isolated common iliac artery aneurysms and suggestions regarding diameter thresholds for intervention. J Vasc Surg. 2021 Feb 19:S0741-5214(21)00232-9.

    Deery SE, Schermerhorn ML. Should Abdominal Aortic Aneurysms in Women be Repaired at a Lower Diameter Threshold? Vasc Endovascular Surg. 2018 Oct;52(7):543-547.

    Golledge J. Abdominal aortic aneurysm: update on pathogenesis and medical treatments. Nat Rev Cardiol. 2018 Nov 15.

    Groeneveld ME, Meekel JP, Rubinstein SM, Merkestein LR, Tangelder GJ, Wisselink W, Truijers M, Yeung KK. Systematic Review of Circulating, Biomechanical, and Genetic Markers for the Prediction of Abdominal Aortic Aneurysm Growth and Rupture. J Am Heart Assoc. 2018 Jun 30;7(13).

    Holden A. Aneurysm Repair with Endovascular Aneurysm Sealing: Technique, Patient Selection, and Management of Complications. Tech Vasc Interv Radiol. 2018 Sep;21(3):181-187.

    Holden A, Hill A. Endoluminal Management of Infra-renal Aortic and Aorto-iliac Aneurysms. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1788-1797.

    Hu DK, Pisimisis GT, Sheth RA. Repair of abdominal aortic aneurysms: preoperative imaging and evaluation. Cardiovasc Diagn Ther. 2018 Apr;8 (Suppl 1):S157-S167

    Huff CM, Silver MJ, Ansel GM. Percutaneous Endovascular Aortic Aneurysm Repair for Abdominal Aortic Aneurysm. Curr Cardiol Rep. 2018 Jul 26;20(9):79.

    Perini P, Mariani E, Fanelli M, Ucci A, Rossi G, Massoni CB, Freyrie A. Surgical and Endovascular Management of Isolated Internal Iliac Artery Aneurysms: A Systematic Review and Meta-Analysis. Vasc Endovascular Surg. 2021 Apr;55(3):254-264.

    Shan L, Saxena A, Goh D, Robinson D. A systematic review on the quality of life and functional status after abdominal aortic aneurysm repair in elderly patients with an average age older than 75 years. J Vasc Surg. 2018 Dec 18.

    Shaw SE, Preece R, Stenson KM, De Bruin JL, Loftus IM, Holt PJE, Patterson BO. Short Stay EVAR is Safe and Cost Effective. Eur J Vasc Endovasc Surg. 2018 Nov 12.

    Sousa LHD, Baptista-Silva JC, Vasconcelos V, Flumignan RL, Nakano LC. Internal iliac artery revascularisation versus internal iliac artery occlusion for endovascular treatment of aorto-iliac aneurysms. Cochrane Database Syst Rev. 2020 Jul 21;7(7):CD013168.

    Williamson JS, Ambler GK, Twine CP, Williams IM, Williams GL. Elective Repair of Abdominal Aortic Aneurysm and the Risk of Colonic Ischaemia: Systematic Review and Meta-Analysis. Eur J Vasc Endovasc Surg. 2018 Jul;56(1):31-39

    Ying AJ, Affan ET. Abdominal Aortic Aneurysm Screening: A Systematic Review and Meta-analysis of Efficacy and Cost. Ann Vasc Surg. 2019 Jan;54:298-303.e3.

    Zhou KZ, Maingard J, Phan K, Kok HK, Lee MJ, Brooks DM, Chandra RV, Hirsh JA, Asadi H. The 100 most cited articles in the endovascular treatment of thoracic and abdominal aortic aneurysms. J Vasc Surg. 2018 Nov;68(5):1566-1581. 

  5. Guidelines

  6. literature search

    Literature search on the pages of pubmed.