Jan Hofer

In situ rifampin-soaked grafts with omental coverage and antibiotic suppression are durable with low reinfection rates in patients with aortic graft enteric erosion or fistula

OBJECTIVE We previously reported that in situ rifampin-soaked grafts (ISRGs) were safe in select patients with aortic graft infections, with the best results in those with aortic graft enteric erosion or fistula (AGEF). This study evaluates the late results of ISRG for AGEF. METHODS From 1990 to 2008, 183 patients were treated for aortic graft infections (121 primary and 62 AGEF). We reviewed 54 patients treated for AGEF with a standard protocol, which included excision of the infected part of the graft, intestinal repair, ISRG with omental wrap, and long-term antibiotics. We excluded 8 patients with AGEF (13%) treated with axillofemoral grafts (AXFG, n = 5) or in situ femoral vein (n = 3) due to excessive perigraft purulence. Endpoints were early morbidity and mortality, late survival, reinfection, and graft-related complications. RESULTS There were 45 male patients and 9 female patients with a mean age of 69 ± 9 years. Presentation was gastrointestinal bleeding in 33 patients, fever in 25 patients, and hemorrhagic shock in 10 patients. Other features were perigraft fluid in 29 patients and purulence in 9 patients. Forty-two patients (80%) had infections isolated to a portion of the graft body or limb, with the remainder of the graft well incorporated. Total graft excision was performed in 31 patients and partial excision in 23 patients. Total operating time was 6.2 ± 1.9 hours. Postoperative complications occurred in 28 patients (52%), and there were 5 deaths (9%). Operative mortality was 2.3% in stable patients (1 of 44) and 40% in those with hemorrhagic shock (4 of 10; P < .001). The hospital stay was 20 ± 18 days. Mean follow-up was 51 months (range, 3-197 months). Five-year patient survival, primary graft patency, and limb salvage rates were 59 ± 8%, 92 ± 5%, and 100%, respectively. There were no late graft-related deaths. There were two (4%) graft reinfections, one that was treated with axillofemoral bypass, and the other with perigraft fluid aspiration and oral antibiotic suppression. CONCLUSION ISRGs with omental wrap and long-term antibiotics are associated with low reinfection rates in patients with AGEF who do not have excessive perigraft purulence. Graft patency and limb salvage rates are excellent.

Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones

Purpose: To investigate outcomes of manufactured fenestrated and branched endovascular aortic repair (F‐BEVAR) endografts based on supraceliac sealing zones to treat pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). Methods: A total of 127 patients (91 male; mean age, 75 ± 10 years old) were enrolled in a prospective, nonrandomized single‐center study using manufactured F‐BEVAR (November 2013‐March 2015). Stent design was based on supraceliac sealing zone in all patients with ≥ four vessels in 111 (89%). Follow‐up included clinical examination, laboratory studies, duplex ultrasound, and computed tomography imaging at discharge, 1 month, 6 months, and yearly. End points adjudicated by independent clinical event committee included mortality, major adverse events (any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss >1 L), freedom from reintervention, and branch‐related instability (occlusion, stenosis, endoleak or disconnection requiring reintervention), target vessel patency, sac aneurysm enlargement, and aneurysm rupture. Results: There were 47 pararenal, 42 type IV, and 38 type I‐III TAAAs with mean diameter of 59 ± 17 mm. A total of 496 renal‐mesenteric arteries were incorporated by 352 fenestrations, 125 directional branches, and 19 celiac scallops, with a mean of 3.9 ± 0.5 vessels per patient. Technical success of target vessel incorporation was 99.6% (n = 493/496). There were no 30‐day or in‐hospital deaths, dialysis, ruptures or conversions to open surgical repair. Major adverse events occurred in 27 patients (21%). Paraplegia occurred in two patients (one type IV, one type II TAAAs). Follow‐up was >30 days in all patients, >6 months in 79, and >12 months in 34. No patients were lost to follow‐up. After a mean follow‐up of 9.2 ± 7 months, 23 patients (18%) had reinterventions (15 aortic, 8 nonaortic), 4 renal artery stents were occluded, five patients had type Ia or III endoleaks, and none had aneurysm sac enlargement. Primary and secondary target vessel patency was 96% ± 1% and 98% ± 0.7% at 1 year. Freedom from any branch instability and any reintervention was 93% ± 2% and 93% ± 2% at 1 year, respectively. Patient survival was 96% ± 2% at 1 year for the entire cohort. Conclusions: Endovascular repair of pararenal aortic aneurysms and TAAAs, using manufactured F‐BEVAR with supraceliac sealing zones, is safe and efficacious. Long‐term follow‐up is needed to assess the impact of four‐vessel designs on device‐related complications and progression of aortic disease.

Neuromonitoring, Cerebrospinal Fluid Drainage, and Selective Use of Iliofemoral Conduits to Minimize Risk of Spinal Cord Injury During Complex Endovascular Aortic Repair:

Purpose: To review outcomes of continuous motor/somatosensory-evoked potential (MEP/SSEP) monitoring, cerebrospinal fluid drainage, and selective use of iliofemoral conduits in patients undergoing endovascular repair of descending thoracic aneurysm (DTA) and thoracoabdominal aortic aneurysms (TAAAs). Methods: The clinical data of 49 patients (mean age 75±8 years; 38 men) who underwent endovascular repair of DTA and TAAAs (2011–2014) were reviewed. All patients had cerebrospinal fluid drainage, permissive hypertension (mean arterial pressure ≥80 mm Hg), and MEP/SSEP monitoring. There were 44 (90%) patients with TAAAs and 5 (10%) with DTA. Types I and II TAAAs were repaired in staged procedures. Iliofemoral conduits were used for small iliac arteries and to minimize time of lower extremity ischemia in patients with difficult anatomy. In patients with changes in MEP/SSEPs, a standardized protocol was employed to optimize spinal cord perfusion and restore lower extremity blood flow. Endpoints were mortality, spinal cord injury (SCI), and lower extremity ischemic complications. Results: Sixteen (33%) patients had staged TAAA repair. A total of 163 visceral arteries were targeted by fenestrations and branches (mean 3.7±1.0 vessels/patient). Temporary iliofemoral conduits were used in 16 limbs/14 patients. A stable MEP/SSEP was achieved in all patients. Thirty-one (63%) patients had a ≥75% decrease in MEP/SSEP amplitude in 50 limbs starting on average 75±28 minutes after obtaining vascular access. MEP/SSEP amplitude improved with maneuvers in 12 (39%) patients and returned to baseline with restoration of lower extremity flow in all except 1 patient who developed immediate SCI. Thirty-day mortality was 4%. Three (6%) patients had SCI, 2 permanent and 1 temporary at 14 days. There were no lower extremity ischemic complications. Conclusion: Neuromonitoring predicted immediate SCI and allowed use of a protocol to optimize spinal cord and lower extremity perfusion during complex endovascular aortic repair. Larger clinical experience is needed to evaluate the efficacy of neuromonitoring to prevent SCI.

Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts

Purpose: The study purpose was to review the outcomes of patients treated for thoracoabdominal aortic aneurysms using endovascular repair with fenestrated and branched stent‐grafts in a single center. Methods: We reviewed the clinical data of the first 185 consecutive patients (134 male; mean age, 75 ± 7 years) treated for thoracoabdominal aortic aneurysms using fenestrated and branched stent‐grafts. Graft design evolved from physician‐modified endografts (2007‐2013) to off‐the‐shelf or patient‐specific manufactured devices in patients enrolled in a prospective physician‐sponsored investigational device exemption protocol (NCT 1937949 and 2089607). Outcomes were reported for extent IV and extent I to III thoracoabdominal aortic aneurysms, including 30‐day mortality, major adverse events, patient survival, primary target vessel patency, and reintervention. Results: A total of 112 patients (60%) were treated for extent IV thoracoabdominal aortic aneurysms, and 73 patients (40%) were treated for extent I to III thoracoabdominal aortic aneurysms. Demographics and cardiovascular risk factors were similar in both groups. A total of 687 renal‐mesenteric arteries (3.7 vessels/patient) were targeted by 540 fenestrations and 147 directional branches. Technical success was 94%. Thirty‐day mortality was 4.3%, including a mortality of 1.8% for extent IV and 8.2% for extent I to III thoracoabdominal aortic aneurysms (P = .03). Mortality decreased in the second half of clinical experience from 7.5% to 1.2%, including a decrease of 3.3% to 0% for extent IV thoracoabdominal aortic aneurysms (P = .12) and 15.6% to 2.4% for extent I to III thoracoabdominal aortic aneurysms (P = .04). Early major adverse events occurred in 36 patients (32%) with extent IV thoracoabdominal aortic aneurysms and 26 patients (36%) with extent I to III thoracoabdominal aortic aneurysms, including spinal cord injury in 2 patients (1.8%) and 4 patients (3.2%), respectively. Mean follow‐up was 21 ± 20 months. At 5 years, patient survival (56% and 59%, P = .37) and freedom from any reintervention (50% and 53%, P = .26) were similar in those with extent IV and extent I to III thoracoabdominal aortic aneurysms. Primary patency was 93% at 5 years. Conclusions: Endovascular repair of thoracoabdominal aortic aneurysms can be performed with high technical success and low mortality and morbidity. However, the need for secondary reinterventions and continued graft surveillance represents major limitations compared with results of conventional open surgical repair. Long‐term follow‐up is needed before the widespread use of these techniques in younger or lower‐risk patients.

Assessment of aortic wall thrombus predicts outcomes of endovascular repair of complex aortic aneurysms using fenestrated and branched endografts

Objective The goal of this study was to investigate the correlation between atherothrombotic aortic wall thrombus (AWT) and clinical outcomes in patients treated by fenestrated‐branched endovascular aortic repair (F‐BEVAR) and present a new classification system for assessment of AWT burden. Methods The clinical data of 301 patients treated for pararenal and thoracoabdominal aortic aneurysms (TAAAs) by F‐BEVAR was reviewed. The study excluded 89 patients with extent I to III TAAA because of extensive laminated thrombus within the aneurysm sac. Computed tomography angiograms were analyzed in all patients to determine the location, extent, and severity of atherothrombotic AWT. The aorta was divided into three segments: ascending and arch (A), thoracic (B) and renal‐mesenteric (C). Volumetric measurements (cm3) of AWT were performed using TeraRecon software (TeraRecon Inc, Foster City, Calif). These volumes were used to create an AWT index by dividing the AWT volume from the total aortic volume. A classification system was proposed using objective assessment of the number of affected segments, thrombus type, thickness, area, and circumference. Clinical outcomes included 30‐day mortality, neurologic and gastrointestinal complications, renal events (Risk, Injury, Failure, Loss of kidney function, End‐stage renal disease [RIFLE]), and solid organ infarction. Results The study included 212 patients, 169 men (80%) and 43 women (20%), with a mean age of 76 ± 7 years. A total of 700 renal‐mesenteric arteries were incorporated (3.1 ± 1 vessels/patient). AWT was classified as mild in 98 patients (46%) and was considered moderate or severe in 114 (54%). There was one death (0.5%) at 30 days. Solid organ infarction was present in 50 patients (24%), and acute kidney injury occurred in 45 patients (21%) by RIFLE criteria. An association with higher AWT indices was found for time to resume enteral diet (P = .0004) and decline in renal function (P = .0003). Patients with acute kidney injury 2 by RIFLE criterion had significantly higher (P = .002) AWT index scores in segment B. Spinal cord injury occurred in three patients (1.4%) and stroke in four (1.9%), but were not associated with the AWT index. Severity of AWT using the new proposed classification system correlated with the AWT index in all three segments (P < .001). Any of the end points occurred in 35% of the patients with mild and in 53% of those with moderate or severe AWT (P = .016). Conclusions AWT predicts solid organ infarction, renal function deterioration, and longer time to resume enteral diet after F‐BEVAR of pararenal and type IV TAAAs. Evaluation of AWT should be part of preoperative planning and decision making for selection of the ideal method of treatment in these patients.

Outcomes of upper extremity during fenestrated-branched endovascular aortic repair

Objective Upper extremity (UE) access is frequently used during fenestrated‐branched endovascular aortic repair (F‐BEVAR) to facilitate catheterization of downgoing vessels. Limitations include risk of cerebral embolization and of UE arterial or peripheral nerve injury. The aim of this study was to assess outcomes of F‐BEVAR using UE access. Methods We reviewed the clinical data of 334 consecutive patients (74% males; mean age 75 ± 8 years) treated by F‐BEVAR for thoracoabdominal aortic aneurysms or pararenal aortic aneurysms between 2007 and 2016. Patients who underwent F‐BEVAR with an UE approach for catheterization of the renal and/or mesenteric arteries were included in the study. End points were technical success, mortality, and a composite of access‐related complications including cerebral embolization (stroke/transient ischemic attack), peripheral nerve injury, and axillary‐brachial arterial complications requiring intervention. Results There were 243 patients (73%) treated by F‐BEVAR with UE access, including 147 patients (60%) with thoracoabdominal aortic aneurysms and 96 patients (40%) with pararenal aortic aneurysms. A total of 878 renal–mesenteric arteries were incorporated by fenestrations or branches with a mean of 3.6 ± 0.8 vessels per patient. All patients had surgical exposure of the brachial artery. The left side was selected in 228 (94%) and the right side in 15 (6%). The technical success of target vessel incorporation was achieved in 99% of patients (870 of 878). Arterial closure was performed using primary repair in 213 patients (88%) or bovine patch angioplasty in 29 (12%). Patch closure was required in 13% of patients (21 of 159) treated by 10‐ to 12F sheaths and 8% (7 of 83) of those who had 7‐ to 8F sheaths (P = .19). There were six deaths (2.5%) at 30 days or within the hospital stay, none owing to access‐related complications. Major access‐related complication occurred in eight patients (3%), with no difference between the 10‐ to 12F (6 of 159 [4%]) or 7‐ to 8F sheaths (2 of 83 [2%]; P = .45). Two patients (1%) had transient median nerve neuropraxia, which resolved within 1 year. One patient (0.5%) required surgical evacuation of an access site hematoma. There were no UE arterial pseudoaneurysms, occlusions, or distal embolizations. Five patients (2%) had strokes (three minor, two major), occurring more frequently with right side (2 of 15 [13%]) as compared with left‐sided access (3 of 228 [1%]; P = .03). After a mean follow‐up of 38 ± 15 months, there were no other access‐related complications or reinterventions. Conclusions UE arterial access with surgical exposure was associated with a low rate of complications in patients treated with F‐BEVAR. Closure with patch angioplasty is frequently needed, but there were no arterial occlusions, pseudoaneurysms, or distal embolizations requiring secondary procedures. Graphical Abstract Figure. No caption available.

VESS17. Upper Extremity Access for Fenestrated-Branched Endovascular Aortic Repair

Objectives: Upper extremity (UE) access during fenestrated-branched endovascular aortic repair (F-BEVAR) facilitates catheterization of mesenteric arteries but carries added risk of arterial injury and neurologic complications. The aim of this study was to assess outcomes of F-BEVAR using UE access. Methods: We reviewed the clinical data of 334 consecutive patients treated by F-BEVAR (2007-2016). Patients who had procedures with UE arterial access for renal-mesenteric catheterization were included in the study. End points were technical success, mortality, stroke, peripheral nerve injury, UE arterial complications (dissection, thrombosis, hematoma requiring intervention, pseudoaneurysm, or distal embolization), and freedom from UE thrombosis or reintervention. Results: There were 243 patients (74% male; mean age, 75 6 8 years) treated for 148 thoracoabdominal and 95 pararenal aortic aneurysms using UE arterial access. A total of 838 renal-mesenteric arteries were incorporated by fenestrations or branches (3.4 6 0.3 vessels/patient). UE arterial access was performed using surgical exposure of the proximal brachial artery in 171 patients, distal brachial artery in 62, or infraclavicular axillary artery in nine. Access was left-sided in 228 patients (94%) and right-sided in 15 (6%). Large-profile sheaths (10F-12F) were used in 159 patients (66%) and smaller profile (7F-8F) in 84 (34%). Technical success of target vessel incorporation was achieved in 99% (829 of 838). Thirty-day mortality was 2.5% (6 of 243). UE arterial complications occurred in 8 patients (4%), including focal dissection in 5 (2%), and transection, in situ thrombosis or hematoma requiring surgical evacuation in 1 patient each. Flow-limiting UE arterial lesions were diagnosed intraoperatively and successfully treated by patch angioplasty in six patients and interposition vein graft in one. Two patients (1%) developed UE peripheral nerve neurapraxia. There were no pseudoaneurysms or distal embolizations. Four patients (2%) had stroke (3 minor, 1 major), which were more frequent with right-sided compared to leftsided UE arterial access (2 [13%] vs 2 [0.9%]; P < .001). Stroke was not associated with type of aortic arch, sheath profile, or presence of subclavian artery calcification or partial thrombus (P > .05). Mean follow-up was 38 6 15 months. There were no late UE arterial stenoses, thromboses, accessrelated complications, or reinterventions. Conclusions: UE arterial access using surgical exposure and largediameter sheaths was associated with low rates of complications, stroke, and peripheral nerve injuries in patients treated by F-BEVAR. Left-sided UE access was associated with lower stroke rates.