Who should do endovascular repair of complex aortic aneurysms and how should they do them?

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ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net

Who should do endovascular repair of complex aortic aneurysms and how should they do them? Hiroshi Banno a,*, Jean Marzelle b, Jean-Pierre Becquemin b a b

Department of Vascular Surgery, Nagoya University Hospital, Nagoya, Japan Department of Vascular Surgery, Henri Mondor Hospital, Creteil, France

article info

abstract

Article history:

Background: Cure of aneurysms which involve the aorta at the level of the visceral arteries

Received 30 January 2014

and the thoracoabdominal segment remains a considerable surgical enterprise with a

Received in revised form

relatively high mortality and morbidity despite improvements of the surgical procedure

15 January 2015

and anesthetic technique. Fenestrated and branched endovascular stent grafts are

Accepted 31 March 2015

currently available offering an attractive less invasive option especially for most frail pa-

Available online 12 May 2015

tients. These grafts are relatively recent, technically more demanding to insert than the current stent graft for infrarenal aneurysm and besides, given the relative low frequency of

Keywords:

the disease, they are much less used by practitioners. Thus, unconditional widespread of

Complex aortic aneurysm

this sophisticated technique may not necessarily benefit patients.

Endovascular aortic repair

Methods: We reviewed our experiences and articles regarding this concern, 1) who should

Fenestrated

perform this new technique and 2) in what kind of setting.

Branched

Conclusion: Based on the combined complexities of 1) patients selection, 2) proper planning

Fenestrated endovascular aortic

and manufacturing of the graft, 3) the need for outstanding imaging and operating facil-

repair (FEVAR)

ities, 4) and the required endovascular skill of physicians involved in the procedure, we feel

Branched endovascular aortic repair

that only highly specialized centers should be allowed to perform this complex procedure.

(BEVAR)

© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Open repair of thoracoabdominal aortic aneurysms (TAAA) is one of the most technically demanding and complex procedures of vascular surgery. While intraoperative technique or perioperative medical care has improved over time, the real world mortality remains approximately 20% at one month reaching 31% at 1 year.1,2 In addition, spinal cord ischemia which is one of the most catastrophic complications after TAAA repair, occurs in more than 10% of cases, even in high volume centers.3 Survivors after open TAAA repair frequently experience debilitating postoperative complications,

prolonged periods of hospitalization and rehabilitation, poor functional outcome, and a significant 1-year mortality rate.4 Currently, endovascular aneurysm repair (EVAR) is the first treatment option for patients with infrarenal abdominal aortic aneurysms (AAA). Endovascular repair of aneurysms of the descending thoracic aortic is also widely used, due to a lower mortality and a lower risk of spinal cord ischemia.5 More recently, endovascular devices have been developed to deal with complex endovascular repair such as para-visceral and thoracoabdominal aortic aneurysms (Figs. 1, 2).

* Corresponding author. Department of Vascular Surgery, Nagoya University Hospital, 65 Tsurumai-cho, Syowa-ku, 466-8550 Nagoya, Japan. Tel.: þ81 52 744 2224; fax: þ81 52 744 2226. E-mail address: [email protected] (H. Banno). http://dx.doi.org/10.1016/j.surge.2015.03.004 1479-666X/© 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

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287

Fig. 1 e 3D CT after fenestrated EVAR.

Therefore, the questions of 1) who should perform this new technique and 2) in what kind of setting need to be addressed.

Hospital or surgeon volume Numerous studies have shown that surgical mortality is linked to the hospital volume of surgical procedures6 and

surgeon's case load.7 The Leap Frog Group, an American coalition of 150 large-volume health care purchasers, defined, on the basis of clinical outcomes, high-volume centers for AAA repair as those that performed 50 elective AAA repairs per year (The leap frog group. Factsheet) and suggested that elective AAA repairs should be referred only to high-volume centers.8 For more complex aortic aneurysms, such as TAAA, the overall mortality of open surgery exceeds 20%, and

Fig. 2 e 3D CT after branched and fenestrated EVAR.

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again higher hospital and surgeon treatment volumes contribute to better outcome (high volume hospital vs. low volume hospital: 27.4% vs. 15.0%, and high volume surgeon vs. low volume surgeon: 25.6% vs. 11.0%).1 Evidence of the superiority of endovascular repair of complex aortic aneurysm performed in high volume centers is still lacking. With EVAR, the relationship between hospital volume and operative mortality still remains.9,10 High volume hospitals are more likely to use the endovascular approach, explaining a significant portion of the observed impact of hospital volume on mortality. Intuitively, similar differences should be observed with endovascular repair of complex aortic aneurysm. The threshold of annual cases to achieve acceptable results is unknown: TAAA is a rarer disease than AAA, and if the cut-off number decided is 50 per year, only a few very high volume centers can meet this criterion. The UK National Health Service Commissioning Board (NHS CB) suggests that the provider should have an annual aortic practice of over 100 cases, and a projected activity for these specific interventions in excess of 24e30 cases to maintain high levels of expertise.11

Learning curve Endovascular repair of complex aortic aneurysm with fenestrated or branched graft is a demanding procedure. In addition to the risk of major complications, various problems can cause short or long-term technical or clinical failure. In many surgical procedures, it is agreed that the institutional learning curve is completed after 20 cases. Studies addressing the problem of learning curves with EVAR are scarce. Forbes et al. reported that a single surgeon would need 20 cases to reach optimal results in an experienced environment.12 Another group reported that the short-term technical success rate significantly increased after 35 cases with a single device.13 In the field of endovascular repair of TAAA, learning curves include not only the skills for device implantation, but also for sizing and planning, intraoperative imaging, salvage techniques and postoperative patient care. Providers of complex aortic aneurysm should be able to demonstrate an established case series of 20 as a minimum, but preferably in excess of 40 cases.

Multidisciplinary team (MDT) There is lack of evidence about the team for endovascular treatment of complex aortic aneurysm, however we believe that multidisciplinary team is mandatory. The provider should have a defined team responsible for the care of patients with complex aortic disease. We strongly advocate that vascular surgeons, interventional radiologists, anesthetists with vascular practice, cardiothoracic surgeons in selected cases (arch repair), be core members of the team, and work in close cooperation. It is the best way to appropriately select and take care of these challenging patients and in cases of complication such as occlusion, endoleak or bleeding to rapidly intervene either by endovascular or by open surgery. Regular MDT meetings, where preoperative planning

and postoperative management would be discussed, should take place.

Optimal endovascular suite and image guidance In our unit our practice changed over time. Initially, procedures were performed in the OR equipped with a portable Carm. For the complex cases, we currently use a hybrid room. Neither the classic operating room with portable C-arm nor the conventional angiography suite is optimally suited for fenestrated and/or branched EVAR. Both aseptic environment and high quality imaging are required. Reports of incidence of graft infection according to the place of the procedure are scarce, however, given the dramatic consequences of infection, asepsis remains a critical issue and asepsis is generally better controlled in an operating room than in an angiography suite. Besides, compared to standard EVAR, complex endovascular procedures increase the need for open surgery either for the approach (surgical conduit) or to deal with intraoperative complications such as acute limb occlusion or iliac or femoral arteries damages. On the other hand, complex endovascular procedures require high-quality imaging. Fixed system is superior in terms of quality of imaging and stability during the procedures. Early in our experience we had cases where, due to the overheating of the portable system, some procedures had to be interrupted. An operating room with a fixed fluoroscopy unit is ideal solution and the benefit of “Hybrid Room” is emerging and rapidly adopted in large volume centers. Besides, fixed systems are equipped with dedicated software, which allow accurate road mapping techniques such as overlay imaging which facilitate the procedures.14 Our group, comparing image fusion of preprocedural CT with intraprocedural fluoroscopy to standard roadmapping methods, reported a significant reduction of injected contrast medium volume (2D and 3D angiography) and a trend toward a reduction of type I endoleak15 (Figs. 3, 4).

Sizing and planning Precise preoperative sizing and planning for EVAR, influences initial and long-term success.16 It is all the more critical with complex procedures.17 In order to proper plan the manufacturing of fenestrated and/or branched devices, comprehensive knowledge of 3D workstations along with a large clinical experience is mandatory. Several softwares are available with semi-automated centerline. In our institution, we use the Aquarius iNtuition software (TeraRecon, San Mateo, Calif). The centerline is built on multiplanar reconstructions, perpendicular to the main direction of flow, and if necessary, corrected manually. Aortic diameters at the level of each visceral branch, and of proximal and distal landing zone are measured in planes perpendicular to the centerline. Visceral artery orientation is assessed relative to a line extending anteriorly from the centerline of the aorta. Clockwise deviation is assigned a positive value, and counter clockwise deviation a negative value. A stretch view is used to assess the longitudinal distance between the vessels. Proximal and distal sealing zones diameters should also be

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Device selection (fenestrated or branched device)

Fig. 3 e Hybrid operating room.

assessed along with the presence of calcification, mural thrombus and angulation. Inter-observer variability of measurements should be taken into account.18 We reported that agreements between two independent observers were associated with good results. On the contrary, in cases of discrepancies, difficulties in catheterization and or bridge stent placement were not rare. We also noted that fenestrated or branched devices designed by planning centers of manufacturers resulted in a few mismatch between fenestration and target vessels locations during the procedures. As the operator is responsible for patient's outcome, we strongly recommend that he takes care or controls the planning himself. This effort avoids misunderstanding of landing zone choice, and stent graft positioning.

Three techniques can be used to treat short or no neck aortic aneurysm or TAAA: parallel techniques, fenestration, and/or branch. The parallel technique excludes the aneurysm with an aortic stent graft and maintains the visceral arteries patency by covered stents placed parallel to the aortic graft. All stents are commercially available and ready for use. However, due to a relatively high rate of endoleak through gutters between stents, it remains for many authors, including our group, a bailout procedure.19 The choice between fenestrated or branch graft is based on anatomic consideration. Branches have advantages: they provide a long overlap between the components, whereas fenestrations offer almost no overlap. The latter may be a disadvantage in terms of disconnection and endoleak risks. Branches are more flexible in terms of positioning since the distal tip of the branches is left one or two centimeters away from the ostia of the target vessels, which permits some malposition or disorientation. Ultimately, the main factor of choice is the aortic diameter at the level of the target vessel. If the aorta is >30 mm, branch is feasible, if less than 30 mm, a fenestration is the only option. Of note however they are still many anatomic exclusion criteria for branched or fenestrated stent grafts and the rejection rate for this technique is in the range of 40%.20

Implantation procedure We follow the following steps. All patients are treated in a hybrid room under general anesthesia. Before draping, the overlay imaging is set up. 100 U/kg body weight of heparin is injected intravenously and repeated every 2 h.

Fenestrated stent graft implantation

Fig. 4 e Image fusion guidance.

Both common femoral arteries are approached surgically. To assess the correct device orientation, prior to insertion, fenestrations, branches and various opaque markers of the aortic device are checked under fluoroscopy. The main aortic device is then introduced and adequately placed by matching the fenestration and the lowest target vessel under fusion image guidance. By removing the introducer sheath, the stent graft is deployed however thanks to a diameter-reducing tie system the graft is still partially constrained. At this stage the stent graft can still be repositioned. A 20e24 Fr., 45 mm long, sheath (according to the number of fenestrations) is inserted via the contralateral side. The tip of the sheath is positioned within the aortic stent graft. 5 Fr sheaths are introduced by direct punctures of the large sheath's valve (i.e. specifically avoiding multiple occupancy of the valve's central channel that would generate continuous bleeding). Using adequate catheters, fenestrations are catheterized, followed by placement of 7 Fr Destination sheaths (Terumo Medical Corp, Somerset, NJ) and bridging stent grafts (Atrium, Hudson, NH) are placed in each target vessel. After full deployment of the main body stent graft, bridging stent grafts are deployed. Their proximal end protrude by 3e4 mm in the aortic stent lumen and are flared

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using a 12 mm diameter, 2 cm long angioplasty balloon. Supplemental support may be necessary by additional selfexpandable stents. To complete the aortic repair, additional components, such as thoracic and/or distal bifurcated stent graft or iliac branched devices, are then inserted.

Branched stent graft implantation Two options exist for branches. Side branches can be used for all the four visceral vessels, or a mixed device with both branches and fenestrations can be manufactured. The types of branches are chosen according to the diameter, length and angulation of the aorta and visceral vessels. Branched stent grafts have no diameter-reducing ties. The device is introduced from the groin and fully deployed, and then branches are accessed from the arm, often over a preloaded wire. A 12 Fr sheath is positioned at the level of the descending thoracic aorta. A10 Fr sheath is subsequently advanced within the 12 Fr sheath and each target vessel is catheterized and reconstructed with self-expandable stent grafts (Fluency; C. R. Bard, Inc, Murray Hill, NJ; or Viabahn; W. L. Gore & Associates, Inc, Flagstaff, Ariz).

Clinical results of fenestrated and/or branched endovascular aortic repair (f/b-EVAR) A few pioneer centers,21e24 and more recently the national UK registry25 have published acceptable results, but reports remain scarce, and little is known yet about which patients will benefit most from this technique. Most recently, we provided the results of the French prospective multicenter study.26 Briefly, 30-day mortality was 6.7% and in-hospital mortality was 10.1%. The outcomes of f/b-EVAR were strongly correlated to the level and to the proximal extent of the aneurysm: the in-hospital mortality and combined mortality and complications rates were respectively 6.5% and 17.2% in juxta or para-renal aortic AAA, 14.3% and 25% in suprarenal AAA or type IV TAAA, and 21.4% and 31% in types I, II or III TAAA. In the two latter groups, mortalities were higher than previously reported, however, when considering 30-day mortality (11.9% in each group) rather than the in hospital mortality it was similar to the literature.27e29 In those groups, interventions lasted longer and were technically more demanding. As such, the duration of procedure was also a factor influencing in-hospital mortality, combined mortality and severe complications, and renal function impairment. The technical success rate was 91.2%, which was comparable to the 90.4% reported by Linsen et al.'s literature review.30 Spinal cord ischemia was more frequent in patients with proximally extended aneurysm (16.6% in types IeIII TAAA and overall 4.1%). Whether staged procedures (i.e. secondary insertion of covered stents in some/all fenestrations/branches) or the addition of a perfusion branch, which maintains blood circulation in the aneurysm sac for a period of time, lead to better outcome remains to be proven. Renal impairment was the most frequent complication: it was 18% in our series and 22.2% in Linsen's literature review.

Conclusions The use of fenestrated and branched endovascular stent grafts for complex aortic aneurysm repair is an area of developing practice in vascular surgery. Recent data indicates that there may be a reduction in immediate post-operative mortality compared to open repair. To answer the question of who should do endovascular repair of complex aortic aneurysms, we strongly support the recommendation that complex aortic aneurysm repair should be performed only in high volume, experienced and well equipped centers. The combined complexities of patients selection, proper planning and manufacturing of the graft, the need for outstanding imaging and operating facilities, and the required endovascular skill of physicians involved in the procedure to justify this opinion.

references

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