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Part XVII
Endovascular Aneurysm Repair
for Ruptured Abdominal Aortic Aneurysm
Endovascular Aneurysm Repair forRuptured Abdominal Aortic Aneurysm
68

Physical Examination

A 77-year-old male presented to the emergency room with severe abdominal and back pain and vomiting. CTA abdomen and pelvis showed rup­tured infrarenal abdominal aortic aneurysm (AAA) with retroperitoneal hematoma. AAA measured 9.7×9.2cm (ap/transverse diameter). The aortic neck angulation was 45–60° (Fig.68.1).

Procedure

He underwent emergency endovascular aneu­rysm repair (EVAR) on June 10, 2016, with Endurant (Medtronic, Dublin, Ireland) graft with main body deployed from the right side (36 × 16 × 166). A multipurpose catheter was used to capture the contralateral gate, and a 16×24× 124 contralateral limb was deployed. On the right side, iliac extension limb of
Fig. 68.1 CTA showing rupture of large AAA with retroperitoneal hematoma
© Springer Nature Switzerland AG 2020 S. S. Hans, Challenging Arterial Reconstructions, https://doi.org/10.1007/978-3-030-44135-7_68
301
302
Fig. 68.2 Intraoperative arteriography and deployment of endograft
68 Endovascular Aneurysm Repair forRuptured Abdominal Aortic Aneurysm
Fig. 68.3 CTA 1 month later showing patent endograft with retroperitoneal hematoma
16×24×124 was also deployed. Completion run showed satisfactory exclusion of the aneurysm. At the end of the operation, abdomen became slightly distended and tense, but as the peak inspiratory pressure was not elevated, abdomen was not re-explored for possible abdominal com­partment syndrome.
A follow-up CTA of the abdomen and pelvis 3 weeks later showed that the size of the aneurysm sac was 9.6 × 9.2 cm with a possibility of an expanding retroperitoneal hematoma with possi-
ble active hemorrhage in the pelvic space (Fig.68.2). Patient therefore underwent abdomi­nal aortography on July 11 which showed satis­factory exclusion of the aneurysm without any endoleak and without any extravasation (Fig.68.3). Patient underwent follow-up duplex ultrasound of the abdomen which showed no evi­dence of endoleak and a stable aneurysm sac. Patient underwent a follow-up CTA scan of the abdomen and pelvis in February 2017 which showed the aneurysm sac to measure 9.1×9.2cm

Discussion

Fig. 68.4 Showing satisfactory endograft deployment without endoleak
for EVAR, most experts agree that EVAR-rst stance is the best for patients in whom the anat­omy is suitable for EVAR [1, 2]. A multicenter trial (IMPROVE trial) conducted in 30 centers (29 UK, 1 CA) randomized 613 patients with ruptured AAA: 316 to EVAR-rst strategy (if aortic morphology was suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health­related quality of life, cost, quality adjusted life years, and effectiveness at 1 year. At 1 year, all­cause mortality was 41.1% for endovascular
Fig. 68.5 CTA showing no endoleak with reduction of
retroperitoneal hematoma
strategy group and 45.1% for open repair group with similar re-intervention rates in each group. They concluded that an endovascular rst strat-
egy for management of rupture AAA does not with possibility of small Type II endoleak (Fig. 68.4). The last CTA of the abdomen and pelvis was performed in November 2019 which showed satisfactory exclusion of the aneurysm with no evidence of endoleak, with residual aneu­rysm sac measuring 9.2×9.2cm (Fig.68.5).
offer a survival benet over 1 year but offers
patients faster discharge with better quality of life
and is cost-effective. Holst etal. reported early
and intermediate outcomes of emergency EVAR
of ruptured infrarenal AAA in 90 consecutive
patients from single institution with a 30-day
mortality of 27% and 1-year mortality of 33%.
They concluded from the retrospective analysis
Discussion
that EVAR is a valid treatment option for rup-
tured AAA [3]. Kapema et al. randomized 116 While many randomized trials comparing EVAR for ruptured AAAs to traditional open surgical repair have failed to show a conclusive advantage
patients with ruptured AAA into open and EVAR
with 30-day mortality of 21% after EVAR and
25% for open repair. They concluded that EVAR
303
304
68 Endovascular Aneurysm Repair forRuptured Abdominal Aortic Aneurysm
may be more effective for ruptured AAA but its costs are prohibitive [4].

References

1. Mansour MA, Zwibelman H.Endovascular repair of
ruptured abdominal aortic aneurysm. In: Hans SS, Shephard AD, Weaver MR, Bove PG, Long GW, edi­tors. Endovascular and open vascular reconstruction: a practical approach. Boca Raton: CRC Press; 2018. p.63–8.
2. McPhee J, Eslami MH, Arous EJ, Messing
LM. Endovascular treatment of ruptured abdominal
aortic aneurysms in the United States (2001–2006): a signicant survival benet over open repair is inde­pendently associated with increased institutional vol­ume. J Vasc Surg. 2009;49:817–26.
3. Holst J, Resch T, Ivanceau K, Bjorses K. Early and intermediate outcome of emergency endovascu­lar aneurysm repair of ruptured infrarenal abdomi­nal aortic aneurysm: a single center experience of 90 consecutive patients. Eur J Vasc Endovasc Surg. 2009;37:413–9.
4. Kapema MR, Dijksman LH, Rimerink JJ, DeGroof AJ, etal. Cost-effectiveness and cost-utility of endo­vascular verses open repair of ruptured abdominal aor­tic aneurysm in the Amsterdam Acute Aneurysm Trial. Br J Surg. 2014;101:208–15.
Ruptured Abdominal Aortic Aneurysms inPatient withType III Endoleak Following Endovascular Aneurysm Repair withEndologix Graft
69
Physical Examination andHistory
A 65-year-old male was seen in the emergency room of the hospital with abdominal pain radiat­ing to back on March 2012. Past medical history was positive for hypertension and acute deep venous thrombosis affecting right femoral vein in February 2012. Patient also had a history of coronary artery disease with a remote myocar-
dial infarction and atrial brillation on warfarin. Past surgical history revealed that patient had undergone endovascular aneurysm repair (EVAR) in July 2011 for an 8 cm transverse diameter infrarenal abdominal aortic aneurysm (AAA) at an outside hospital (Figs. 69.1 and
69.2). Endologix graft was used; however the
exact type of Endologix graft could not be iden­tied. Postoperative CTA of the abdomen and
Fig. 69.1 Preoperative CTA showing infrarenal AAA
© Springer Nature Switzerland AG 2020 S. S. Hans, Challenging Arterial Reconstructions, https://doi.org/10.1007/978-3-030-44135-7_69
305
306
69 Ruptured Abdominal Aortic Aneurysms inPatient withType III Endoleak Following Endovascular…
pelvis in September 2011 showed satisfactory aneurysm repair with aneurysm sac measuring
8.1 × 7.7 cm with no evidence of endoleak (Fig.69.3).
Patient underwent emergent CTA of the abdo­men and pelvis and abdominal aortography which showed Type III endoleak without evi­dence of aneurysm sac rupture.
Fig. 69.2 Intraoperative image showing deployment of
Endologix graft

Procedure

Patient was taken to the operating room and was given four units of fresh frozen plasma to correct his INR (3.1). He underwent placement of two AneuRx (Medtronic, Dublin, Ireland) cuffs measuring 26 × 26 × 40 mm and 28×28×40mm on March 10, 2012 due to the lack of thoracic stent graft available in the oper­ating room. In addition, a left iliac extension limb (AneuRx 20 × 20× 85mm) was placed and extended to the mid external iliac artery as the Endologix (Irvine, CA) endograft was only covering proximal 1.5cm of the left common iliac arteries. CTA of the abdomen and pelvis in March 29, 2012, showed aneurysm sac measur­ing 8.3 × 7.9 cm with resolution of Type III endoleak. Patient was seen in the outpatient clinic in April 2012 with symptoms of left hip claudication which improved gradually. A fol­low- up CTA scan on November 13, 2012, showed aneurysm sac measuring 6.2× 7.1 cm without any evidence of endoleak.
Patient presented to emergency room on March 13, 2013, with increasing abdominal pain of 3–4 days duration. In the emergency room, hisblood pressure was 206/108 mmHg. An emergency CTA scan of the abdomen and
Fig. 69.3 Postoperative CTA showing satisfactory endograft (3 months later)

Discussion

Fig. 69.4 Recurrent Type III endoleak with ruptured AAA with endograft
pelvis showed Type III endoleak (Fig. 69.4). He was administered three units of fresh frozen plasma as INR was 3.7 and taken to the oper­ating room where bilateral femoral access was obtained and 7 F sheaths were inserted. On the right side, an exchange length Glidewire® (Terumo, Somerset, NJ) was advanced over the Kumpe catheter (Cook Medical, Bloomington, IN). Glidewire® was removed and replaced by Lunderquist® wire (Cook Medical); on the left side, an Omniush marker catheter (AngioDynamics, Latham, NY) was passed through the left femoral sheath. We were able to negotiate the disconnected components of Endologix graft with the help of Glidewire and Kumpe catheter. Type III endoleak was sealed using 30×30×150mm valiant thoracic endo­graft followed by Reliant™ balloon (Medtronic)
Fig. 69.5 Deployment of Valiant thoracic endograft for
control of Type III endoleak
angioplasty (Fig.69.5). However patient devel­oped coagulopathy (INR 2.8, PTT 74, platelet
Discussion
count 98,000, and hemoglobin 7.2g); ten units of packed red cells, factor VII, and cryoprecipi­tate were given. As the peak respiratory pressure was markedly elevated (55 cm water), patient underwent decompressive laparotomy for abdominal compartment syndrome, but patient remained hypotensive and expired 12 hours after repair from disseminated intravascular coagulation.
Maleux etal. identied 20 patients (2.1%) with 25 Type III endoleaks among 965 EVAR (1995–
2014). In most cases the underlying mechanism was disconnection of the stent graft components (56%), and a fabric defect was found in 44% patients. Type III endoleak may appear early or late after initial EVAR [1]. In the study reported by Maleux etal., 10% of their patients presented
307
308
69 Ruptured Abdominal Aortic Aneurysms inPatient withType III Endoleak Following Endovascular…
with a rupture or an aortoduodenal stula as the rst sign of Type III endoleak. They treated 22 (88%) Type III endoleaks with endovascular technique and 3 (12%) by open surgical conver­sion [1].
CTA angiography is considered to be the best diagnostic tool to identify a Type III endoleak though plain abdominal lms can conrm a dis­connection of a stent graft limb and its compo­nents. Treatment of a Type III endoleak includes placement of a covered stent across the graft components. If the fabric tear is at the oor divider, relining with conversion of the graft to aorto-uniiliac conguration is a better option. In spite of technically satisfactory repair, Type III endoleak may reoccur in a number of cases as was the case in the present report.
Abdominal compartment syndrome following open or endovascular repair of a ruptured AAA occurs as a result of increased intra-abdominal pressure due to massive volume resuscitation. Due to increased intra-abdominal pressure and extrinsic compression of inferior vena cava, venous return is compromised with resultant decrease in the cardiac output and increase in the systemic vascular resistance. Rubinstein et al. reported 73 patients with abdominal compart­ment syndrome, 44 following open repair of rup­tured AAA and 29 following EVAR with overall mortality of 42% [2]. The authors observed that patients with abdominal compartment syndrome following EVAR for ruptured AAA had higher intraoperative blood and blood product require­ments. They hypothesized that continuous hem­orrhage from lumbar and inferior mesenteric artery through the ruptured aneurysm sac may be responsible for this difference. They recom­mended open ligation of inferior mesenteric artery and lumbar arteries in patients developing abdominal compartment syndrome after EVAR for ruptured AAA [2]. The incidence of abdomi­nal compartment syndrome after EVAR of rup­tured aneurysm is 5.5–8% [2]. But rates as high as 21% had reported using intra-abdominal pres­sure measurements from a indwelling urinary catheter. Patients developing abdominal compart­ment syndrome after repair of ruptured AAA have a higher incidence of bowel ischemia, renal
failure, respiratory failure, and sepsis [2]. Medical therapy of abdominal compartment syndrome includes neuromuscular blockade, positive end­expiratory pressure (PEEP), albumin, and intra­venous diuretics. If abdominal compartment syndrome does not respond to medical therapy, decompressive laparotomy should be performed, and the abdomen should be kept open avoiding adhesions between the intestine and abdominal wall; a vacuum-assisted wound closure is undertaken.
Recently, FDA has sent a notication (October 28, 2019) regarding greater risk of Type III endoleak with Endologix AFX® and Endologix STRATA device [3]. Therefore careful long-term follow-up with imaging studies is necessary in all patients to prevent rupture of AAA following EVAR.According to the FDA warning, this close follow-up is mandatory in patients in whom Endologix device was used.
Invited Commentary fromPaul G.Bove, MD, FACS, FSVM
Unfortunately, in the domain of vascular care, all therapies have a failure rate that is at times not easily predicted. Specically, in dealing with endovascular repair of abdominal aortic aneu­rysms, there are multiple forms of failure that can occur, some of which are early after repair and some may not present for years after implanta­tion. Because of this lack of certainty of success, lifelong surveillance is required of patients who undergo aortic stent graft implantation. This is not unlike other vascular procedures that can fail years after completion. Most importantly, as in other realms of vascular surgery, when problems can be identied through surveillance and treated, this can result in a survival advantage as in the case of aortic stent graft repair.
The authors describe a complex case of a patient with a Type III endoleak following implantation of an Endologix AFX graft, initially treated approximately 8months following initial treatment with two overlapping AneuRx aortic cuffs to treat a Type IIIA endoleak as well as an iliac extension. Unfortunately, 1 year after the
Invited Commentary fromPaul G.Bove, MD, FACS, FSVM
309
primary secondary intervention, the patient pre­sented with rupture, and a Valiant thoracic graft was placed and a laparotomy required for abdom­inal compartment syndrome with the patient expiring shortly thereafter from coagulopathy. Their case represents a real-world experience of the complexities that are faced, the decisions that are necessary, and the resources that are needed to treat patients as we try to create innovative ways to treat uncommon and sometimes unfore­seen problems that present to us in emergent scenarios.
In recent years, there have been numerous communications from the FDA regarding the Endologix aortic stent graft systems. The AFX Endovascular AAA System received approval in
2011. These grafts were produced between 2011 and 2014 with implantations stopping in 2016. In July 2014, the initial AFX with Strata material was replaced by the AFX with Duraply material. In February 2016, the Duraply material was fur­ther modied, and AFX2 became available. In a physician communication in December 2016, Endologix requested all AFX Strata devices be removed from hospital inventory due to an increased number of Type III endoleaks. There also have been modications to the original rec­ommendations in the instructions for use speci­cally with recommendations regarding aortic cuff overlap. On October 15, 2018, the FDA issued a Class 1 Recall of the Endologix AFX Endovascular System. This was following previ­ous communications to providers in September 2017 and again in June 2018 warning about increased Type III endoleaks.
The most recent communication from the FDA on October 28, 2019 [3], was in response to recent abstract data presented from the Kaiser Integrated Health System on their experience with all AFX systems identifying a 2.5% inci­dence of Type II leaks at 2years in their cohort of 603 patients [4]. Admittedly, further analysis needs to be performed, and the limitations of the study as presented are acknowledged with the need for further data. I have no doubt that both the FDA and Endologix Inc. have the best interest of the patient in mind with their vigilant commu­nications and oversight in this complex arena.
Another unique characteristic of the Endologix AFX Endovascular System is its basic structure with an endoskeleton that allows the outer fabric “billow” out. This phenomenon is noted routinely and is to some degree an expected nding and follow-up CT studies. Some authors have suggested that in certain cases this phenom­enon could contribute to graft failure [5]. The most important aspect of billowing is twofold. For the patient who is stable, it is necessary to look specically at the radiographic features from serial exams to identify changes which may suggest progression to graft failure. In the case of the patient who does require a secondary intervention, extensive billowing and if it is in conjunction with aortic angulation may make the passage of guidewires more complex. It is essen­tial to insure that guidewire passage on second­ary procedure is within the endoskeleton and not through it.
There are some real-world experiences that have been used to assist in treating the type of IIIa endoleaks that can be encountered that are specic to the Endologix products. Because of the endoskeleton, a higher degree of attention is required at the time of initial guidewire passage. Adjuncts such as large diameter balloon passage along guidewires to insure proper positioning within the endoskeleton are commonly described. Overlapping aortic cuffs as utilized in the pre­sented case, thoracic aortic segments, or Endologix aortic segments have all been described. At the time of presentation and repair, it is important to insure that there are no other failure modes present such as a Type IIIb leaks or problems at either the aortic or iliac seal zones which could predispose a future Type I problem. This may require placement of additional aortic or iliac extensions or could be treated with com­plete relining utilizing a full aortic stent graft sys­tem from Endologix or another manufacturer. On occasion, explantation could be utilized if needed with open reconstruction.
With this heightened awareness of the prob­lem in general and specic to the Endologix product, the most important takeaway is the importance of understanding the instructions for use and potential limitations of any product and