University of Groningen Advances in complex endovascular aortic surgery Dijkstra, Martijn IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2018 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Dijkstra, M. L. (2018). Advances in complex endovascular aortic surgery [Groningen]: University of Groningen Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 23-03-2018
chapter 1 General introduction
General introduction General introduction advances in complex endovascular aortic surgery 1 In 1948 Dr Rudolph Nissen performed an exploratory laparotomy on one of the most famous scientists of all time. He found that the patient suffered from an abdominal aortic aneurysm. At the time treatment options were limited and ligating the aorta had already been proven ineffective. He therefore wrapped the aneurysm using cellophane hoping this would induce scar tissue formation and reinforce the aneurysm wall. The patient, Dr Albert Einstein, recovered from surgery and lived for several more years until 1955, when he developed severe generalized abdominal pain and died. Autopsy confirmed a ruptured aneurysm. 1 Historically, as illustrated by the first paragraph, surgical procedures for aortic pathology were extensive and invasive. Most commonly for the abdominal aorta, a midline incision and trans-peritoneal approach was used. Subsequent dissection of the retro-peritoneal space exposes the abdominal aorta, roughly from the level of the renal arteries to the iliac bifurcation. Alternatively a retroperitoneal approach can be used, which can be combined with a thoracotomy for more proximal disease. 2, 3 Until recent, this has been the mainstay of treatment for both aneurysmal and occlusive aortic vascular disease. Needless to say, these approaches carry considerable peri-operative morbidity and mortality rates. 4 The most widely used definition for an abdominal aortic aneurysm is an abdominal aorta of more than 30 mm in diameter, measured perpendicular to the vessel. The infra-renal aorta is most commonly affected, but aneurysms can extend to (juxta-renal aneurysms) or beyond the renal arteries (supra-renal aneurysms) in up to 15 % of cases. 5, 6 Distally, concomitant common iliac aneurysms are present in up to 20 % of the patients with an AAA. 7 Pathogenesis is believed to be multi-factorial but remains largely unclear. 8, 9 Several risk factors have been identified, including older age, male sex, Caucasian race, a family history of aortic aneurysms, smoking and the presence of other large vessel aneurysms. 5 The vast majority of AAA patients is asymptomatic and identified incidentally upon physical examination or imaging studies. Symptomatic patients commonly present with non-specific abdominal, back or flank pain. In case of a ruptured aneurysm the classic presentation of severe abdominal pain radiating to the back, hypotension and a palpable pulsatile abdominal mass is present in about 50 % of cases. 5 Rupture of an aortic aneurysm is a surgical emergency and is associated with very high morbidity and mortality rates. 10 To prevent rupture thresholds have been identified and for patients in whom the aneurysm reaches 11
Chapter 1 a certain diameter, elective treatment is the course of action. Current practice guidelines encourage elective treatment for AAAs > 5.5 cm for men and > 5.0 cm for women, and for rapidly growing aneurysms (> 5 mm within 6 months). 2, 3 If the indication for operative repair is established and the patient is deemed fit to undergo an intervention, there are now mainly two options: open surgery or endovascular repair. 2, 3 In 1952 Dubost et al. were the first to report an open AAA repair and the use of a conduit to exclude the aneurysm and restore blood flow. In this case, the thoracic aorta of a 20 year old female donor was used as a bypass, at the time synthetic grafts were not available yet (Figure 1). 11 Advances Figure 1. Post-operative aortogram by Dubost et al. 12
General introduction in operative techniques and the development of synthetic bypass grafts (including polyester (eg. Dacron) and polytetrafluoroethylene (PTFE) grafts) led to the current open surgical treatment which has been the gold standard ever since. The only real contra-indication for open surgical repair is extensive co-morbid conditions with an unacceptable peri-operative mortality and morbidity risk. Relative contra-indications include a hostile abdomen, obesity and limited life expectancy. 1 In order to treat aortic disease without having to undergo major open surgery, endovascular aortic surgery has been developed. 12 In 1986 the first case of an endovascular aneurysm repair was published by the Volodos et al. 13 In the landmark study by Parodi et al. 14 the treatment of 5 patients using an intraluminal, stent-anchored, Dacron prosthetic graft with retrograde cannulation of the common femoral artery was described (Figures 2 and 3). Initially the technique was utilized to treat patients deemed unfit for open surgery because of the novelty of the procedures, lack of follow up data and unknown durability. However, over the past two decades endovascular techniques and devices have evolved rapidly. This has resulted in a valuable alternative to open surgery, which has Figure 2. Schematic by Parodi et al. showing intra-luminal exclusion of an aneurysm by means of Dacron tubular grafts delivered through the transfemoral route. 13
Chapter 1 Figure 3. Aortogram by Parodi et al. showing successful aneurysm exclusion 53 days after endograft implantation. now become the mainstay of treatment for abdominal aortic aneurysms in the United States and other parts of the Western World. 15 Adverse anatomy is the main limitation of EVAR. Ideally there should be adequate proximal and distal landing zones without significant angulation. The exact anatomic criteria depend on specific endograft instructions for use (IFU) as provided by the manufacturer. If however the aneurysm extends up to, or beyond the visceral vessels, EVAR falls short. Several more complex endovascular treatment options have been developed to address this shortcoming, including fenestrated EVAR (FEVAR) 16, branched EVAR (BrEVAR) 17, chimney EVAR (ChEVAR) 18 and thoracic endovascular aneurysm repair (TEVAR). 19 One of the major issues with EVAR is the post-operative occurrence of endoleaks. This occurs when there is persistent blood flow within the aneurysm sac after endograft deployment. Five different types of endoleaks have been described, depending on the origin of the leak (Table 1). Type II endoleaks are generally considered benign, although rupture does occur in a very small proportion of patients. 20 Type I and III endoleaks do have a significant risk of aneurysm rupture if left untreated. 21 The correct identification of endoleaks is therefore very important. Ideally, type I and III endoleaks should be identified peri-operatively and treated where possible. With increasing complexity of endovascular pro- 14
General introduction Table 1. Endoleak classification. Type of endoleak Origin Type I Inadequate seal at graft ends IA Proximal IB Distal IC Iliac occluder Type II Branch vessels, e.g. lumbar or inferior mesenteric artery Type III Disconnection of graft components Type IV Porous graft Type V Endotension, origin unclear 1 cedures, conventional angiography can fall short and many centers perform a pre-discharge CTA in these cases. The development of flat panel detectors with cone beam CT capabilities have made it possible to obtain peri-operative CT-like images. 22 It was hypothesized this allows for accurate endoleak identification and allow for prompt treatment. In addition, the cone beam CT images in conjunction with a pre-operative CTA can be used for image fusion and supply a roadmap. This in turn can facilitate target vessel cannulation and result in decreased operative time, fluoroscopy and contrast dosage. In chapter 2 the use of this novel technique to detect endoleaks and the possible benefits of a roadmap were investigated. For conventional EVAR, there are a number of commercially available endografts. Having several device options gives the operator the advantage to choose an endograft which best matches the patients anatomy. For FEVAR options have been limited. The vast majority of patients have been treated using the Zenith custommade fenestrated endograft (Cook Medical Australia, Brisbane, Queensland, 23, 24 Australia). Alternative endografts have been launched recently, including in 2011 the Fenestrated Anaconda (Vascutek, Renfrewshire, Scotland). 25 This custom-made endograft, based on the infrarenal Anaconda platform, has potential advantages compared to the Zenith endograft, including the option to reposition the endograft after initial deployment, less constraints in terms of fenestration position and upper access for antegrade cannulation of target vessels. In chapter 3 the initial experiences and short-term results with this new endograft in the Netherlands are presented. In FEVAR, high-technical success and good short-term results do not necessarily amount to a good treatment option. Mid- and long-term complications do arise and re-intervention rates are higher compared to open surgery. 26 Longer term results will therefore ultimately decide the performance and value of a new endograft. A follow up study was 15
Chapter 1 undertaken and in chapter 4 the mid-term results of a larger cohort of patients treated with the fenestrated Anaconda in the Netherlands are presented. Both the Zenith and the fenestrated Anaconda endografts have extended the applicability of EVAR. Both endografts are however custom made and typically require 6 to 8 weeks to manufacture, which precludes their use in an acute setting. This presents a problem in patients presenting with either a symptomatic or a ruptured aneurysm that are not suitable for both conventional EVAR and open surgery. Off-the-shelf fenestrated endografts are being developed and used in clinical trials, but are still bound to anatomical restrictions. For these patients other bailout procedures have been developed. The chimney EVAR (Ch-EVAR) procedure was initially used to treat unintentionally overstented target vessels 27, 28 during FEVAR and has successfully been used in patients with juxtarenal aneurysms in urgent and emergency settings. 29, 30 A caveat of this technique is the occurrence of so called gutters between the chimney graft, the main graft and the aortic wall, resulting in endoleaks. 31, 32 Combining the chimney technique with another novel technique called endovascular aneurysm sealing (EVAS) might resolve this. EVAS uses dual balloon-expandable stents surrounded by polymer-filled endobags (Nellix endoprosthesis, Endologix, Irvine, California, USA) which fill the aneurysm sac. 33, 34 In chapter 5 the feasibility of the combined use of chimney grafts and EVAS is investigated in two patients deemed unsuitable for FEVAR and open surgery. As for aneurysmal disease, the gold standard for treatment of aorto-iliac occlusive disease has been open surgery and carries much the same morbidity and mortality risks. 35 Parallel to the growing experience and evolving endovascular techniques in aneurysmal disease, progress has been made for the treatment of occlusive disease as well. 36 The Inter-society Consensus for the Management of Peripheral Arterial Disease (TASC II) 37 guideline recommends endovascular treatment for TASC A and B lesions, and open surgery for TASC C and D (if the operative risk is acceptable). Recent studies on endovascular treatment of aorto-iliac occlusive disease have shown high primary and secondary patency rates (87% and 95 %) in patients with TASC C and D lesions using the covered endovascular repair of the aortic bifurcation (CERAB) technique. 38 A prerequisite for successful treatment is a disease free proximal landing zone. Disease extending up to, or beyond, the visceral vessels precludes endovascular treatment. In chapter 6 the feasibility of the chimney technique combined with the CERAB to extend the proximal landing zone was explored. Lower morbidity and mortality rates are the main reason for pursuing and pushing the boundaries of endovascular treatment. Overall survival benefits 16
General introduction are however debated. Patients often have extensive co-morbid conditions and survival seems to be largely dependent on non-aneurysm related events, which might warrant a conservative strategy in high risk patients. 39 41 This is based on fairly dated trials (published in 2005). Current practice has improved in terms of advanced imaging, improved devices, increased operator experience and patient selection, advances in peri-operative cardiopulmonary care and treatment of peri-operative adverse events. It was hypothesized this led to a decrease in peri-operative morbidity and mortality, even in high risk patients. Chapter 7 describes the outcomes of a large cohort of real-world high risk patients treated with conventional EVAR, specifically in terms of technical success, morbidity and 30-day and 1-year mortality. 1 Having the opportunity to treat extensive segments of the aorta by endovascular means does come with specific complications. Spinal cord ischemia (SCI) and concomitant paraplegia after endovascular aneurysm repair is one of the most dreaded complications, which is especially relevant after TEVAR. 42 44 This has been the scope of extensive research and several preventive measures have been explored (spinal fluid drainage, avoidance of hypotension, staged repair, permissive endoleak, and hypothermia) but no optimal preventive strategy has been established. Guidelines mention some of these, but are not uniform. Chapter 8 aims to provide an overview of preventive measures used and their effectiveness to prevent spinal cord ischemia after TEVAR and recommend an optimal preventive strategy based on the available data. Finally, the results of the studies are summarized and future perspectives discussed in Chapters 9 and 10, in English and Dutch, respectively. 17
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Chapter 1 29. Tolenaar JL, van Keulen JW, Trimarchi S, Muhs BE, Moll FL, van Herwaarden JA. The chimney graft, a systematic review. Ann Vasc Surg. 2012; 26(7): 1030-8. 30. Katsargyris A, Oikonomou K, Klonaris C, Topel I, Verhoeven EL. Comparison of outcomes with open, fenestrated, and chimney graft repair of juxtarenal aneurysms: are we ready for a paradigm shift? J Endovasc Ther. 2013; 20(2): 159-69. 31. Niepoth WW, de Bruin JL, Yeung KK, Lely RJ, Devrome AN, Wisselink W, et al. A proof-of-concept in vitro study to determine if EndoAnchors can reduce gutter size in chimney graft configurations. J Endovasc Ther. 2013; 20(4): 498-505. 32. De Bruin JL, Yeung KK, Niepoth WW, Lely RJ, Cheung Q, de Vries A, et al. Geometric study of various chimney graft configurations in an in vitro juxtarenal aneurysm model. J Endovasc Ther. 2013; 20(2): 184-90. 33. Donayre CE, Zarins CK, Krievins DK, Holden A, Hill A, Calderas C, et al. Initial clinical experience with a sac-anchoring endoprosthesis for aortic aneurysm repair. J Vasc Surg. 2011; 53(3): 574-82. 34. Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, et al. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011; 42(1): 38-46. 35. Garcia-Fernandez F, Marchena Gomez J, Cabrera Moran V, Hermida M, Sotgiu E, Volo Perez G. Chronic infrarenal aortic occlusion: predictors of surgical outcome in patients undergoing aortobifemoral bypass reconstruction. J Cardiovasc Surg (Torino). 2011; 52(3): 371-80. 36. Goverde PC, Grimme FA, Verbruggen PJ, Reijnen MM. Covered endovascular reconstruction of aortic bifurcation (CERAB) technique: a new approach in treating extensive aortoiliac occlusive disease. J Cardiovasc Surg (Torino). 2013; 54(3): 383-7. 37. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter- Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007; 45 Suppl S: S5-67. 38. Grimme FA, Goverde PC, Verbruggen PJ, Zeebregts CJ, Reijnen MM. Editor s Choice - First Results of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aortoiliac Occlusive Disease. Eur J Vasc Endovasc Surg. 2015; 50(5): 638-47. 39. Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010; 362(20): 1863-71. 40. De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, et al. Longterm outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010; 362(20): 1881-9. 41. Brown LC, Powell JT, Thompson SG, Epstein DM, Sculpher MJ, Greenhalgh RM. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess. 2012; 16(9): 1-218. 20
General introduction 42. Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu ZF, Mitchell RS. Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial. J Thorac Cardiovasc Surg. 2007; 133(2): 369-77. 1 43. Ullery BW, Cheung AT, Fairman RM, Jackson BM, Woo EY, Bavaria J, et al. Risk factors, outcomes, and clinical manifestations of spinal cord ischemia following thoracic endovascular aortic repair. J Vasc Surg. 2011; 54(3): 677-84. 44. DeSart K, Scali ST, Feezor RJ, Hong M, Hess PJ, Jr., Beaver TM, et al. Fate of patients with spinal cord ischemia complicating thoracic endovascular aortic repair. J Vasc Surg. 2013; 58(3): 635-42. 21