Use of Aortic Occluders and Endovascular Plugs in a 2-step Hybrid Treatment of Secondary Aortoenteric Fistulas.

Aortoenteric fistula (AEF) is a dreadful complication of abdominal aortic surgery. Surgical treatment is associated to high mortality and requires urgent graft removal with extra-anatomic or in situ reconstruction. Other authors suggest the use of stent grafts, both as a stand-alone procedure or as a bridge solution before open repair. We reviewed the results of a cohort of patients that presented at our institution with an AEF and were treated with a novel 2-step endovascular-open surgical procedure. The first step consisted in immediate endovascular occlusion of the infrarenal graft with deployment, below the renal arteries, of an aortic occluder and/or endovascular plugs. After occlusion of the infrarenal graft, extra-anatomic reconstruction (axillofemoral bypass) was performed. The second step consisted in the removal of the infrarenal graft with aortic stump ligation and took place after a few days recovery to allow improvement of patients' condition. A total of 5 selected patients were treated. Endovascular aortic occlusion was achieved in all cases with the deployment of 1 (3 patients) or 2 (2 patients) devices. The mean interval between the first and the second step was 7 days (min 4-max 13). Complete removal of the aortic graft was possible in all patients. One patient died on the first postoperative day due to multiorgan failure (1 of 5, 20%). Mean survival after discharge was 24 months (min 6-max 36). One patient died at 6 months because of aortic stump blowout. In our initial experience, endovascular aortic occlusion seems an effective option to prevent fatal enteric bleeding and a valuable first-step treatment for selected cases of AEF.

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.

OBJECTIVE: This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. RESULTS: Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. CONCLUSIONS: The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

Unibody endografts for abdominal aortic aneurysm repair reduce radiation and nephrotoxic exposure compared with modular endografts.

BACKGROUND: To compare nephrotoxic and radiation exposure during elective endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms in a selected patient cohort treated with 2 different infrarenal endograft types: the unibody and modular. METHODS: Procedural data were retrospectively collected in a single center, case-controlled study. From January 2010 to January 2012, patients treated with elective EVAR were analyzed. Patients treated for thoracoabdominal aneurysms, aortic dissection, aortoiliac aneurysms, and pseudoaneurysms were excluded. The remaining subjects were divided according to the endograft type: group A treated with a unibody endograft type (60 patients) and group B (57 patients) treated with a modular endograft type. Outcome measures included total procedural time, total fluoroscopy time, and volume of contrast medium. RESULTS: All end points for group A and B were statistically significantly different; median surgical procedure duration was 75 vs. 105 min (P < 0.0001), median volume of iodine contrast injected was 85 vs. 170 mL (P < 0.0001), and median fluoroscopy time was 350 vs. 780 sec (P < 0.0001). CONCLUSIONS: The overall EVAR procedural duration, fluoroscopy time, and volume of contrast medium infusion were significantly reduced in the group treated with the unibody endografts. These results seem to suggest that the unibody endograft may reduce patient risk of nephrotoxic action of the contrast medium, especially important in patients with existing renal insufficiency, and may reduce ionizing radiation exposure for both the patients and operators.

Cryopreserved autologous saphenous vein for staged treatment of bilateral popliteal aneurysms: report of three cases.

Popliteal artery aneurysms are the most common aneurysmal disease of the lower extremity. Although endovascular solutions are gaining consensus, open surgery with interposition grafting remains the standard of care. The great saphenous vein (GSV) is the most commonly used conduit and shows the best long-term results. However, optimal vein segments can sometimes be unavailable, thus leading to the use of unsuitable segments or prosthetic grafts. We report the cases of 3 patients who had bilateral popliteal aneurysms and only 1 GSV that was considered suitable for grafting, without alternative venous segments. All patients underwent staged treatment with the use of the GSV. After the first operation, the remaining GSV was cryopreserved and then reused for the contralateral limb. All patients had an uneventful outcome. No graft occlusions and no aneurysmal dilatations were detected at follow-up. Cryopreservation of autologous vein for staged treatment of bilateral popliteal aneurysms is feasible and seems to avoid the risk of residual GSV loss during the time inbetween the interventions.

Neural damage biomarkers during open carotid surgery versus endovascular approach.

BACKGROUND: Carotid endarterectomy (CEA) is the gold standard for treating severe carotid artery stenosis, whereas carotid artery stenting (CAS) represents an endovascular alternative. The objective of this study was to assess the potential neural damage following open or endovascular carotid surgery measured by peripheral blood concentration of 3 biomarkers: S100ß, matrix metalloproteinase-9 (MMP-9), and d-dimer. METHODS: Data for this prospective investigation were obtained from the Carotid Markers study (January 2010-2011), which sought to measure the levels of specific biomarkers of neuronal damage and thrombosis on candidates to CEA or CAS presenting at the Department of Vascular Surgery of the Nuovo Ospedale S. Agostino Estense of Modena (Italy) at baseline and at 24 hr after surgery. Relevant medical comorbidities were noted. RESULTS: A total of 113 consecutive patients were enrolled in the study, 41 in the endarterectomy group and 72 in the endovascular group. The baseline levels of the studied biomarkers did not show any statistically significant difference between the groups with the exception of MMP-9, which showed higher concentrations in the endovascular group (median 731 vs. 401, P = 0.0007), while 24 hr after surgery the endarterectomy group featured significantly higher peripheral blood concentrations of MMP-9, S100ß, and d-dimer. Conversely, no significant difference was detected in the endovascular group except the d-dimer level. CONCLUSIONS: Neural damage biomarkers demonstrated a substantial difference between open and endovascular carotid surgery, which, if performed in selected patients, may become a less invasive alternative to CEA.

First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial.

OBJECTIVE: This multicenter, prospective, nonrandomized trial was undertaken to evaluate the first-in-human experience with the INCRAFT endograft (Cordis Corporation, Bridgewater, NJ), an ultralow-profile trimodular bifurcate device for the repair of abdominal aortic aneurysms. METHODS: Patients with asymptomatic infrarenal abdominal aortic aneurysms were eligible for enrollment in the trial. Anatomic eligibility criteria included a proximal aortic neck at least 15 mm in length and up to 27 mm in diameter, and an aortic bifurcation ≥18 mm in diameter. Iliofemoral access vessels were required to be large enough to accept the 14F (4.7 mm) outer diameter of the delivery system. The primary efficacy end point was technical success, defined by successful device deployment during the conclusion of the procedure at the desired location without a type I, III, or IV endoleak. The primary safety end point was defined by the absence of a type I, III, or IV endoleak or a device- or procedure-related major adverse event at the 1-month follow-up point. RESULTS: Over a 16-month period divided into two different phases, 57 men and three women with a mean age of 74.4 ± 6.9 years were enrolled at three German and three Italian centers. A percutaneous approach was used in 36 patients (60%). Successful graft deployment at the desired location was achieved in 59 patients (98%). A single patient had successful deployment of the device although it was located more distally than planned. Technical success was achieved in 54 patients (90%); one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined origin. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month; two patients had type I endoleaks. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. No limb thromboses or stent fractures were noted on postoperative imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion through 1 month of follow-up. CONCLUSIONS: The INCRAFT endograft device holds promise as an innovative alternative to currently marketed devices and broadens the eligibility for endovascular aneurysm repair. More definitive observations will be generated as longer-term data from this trial become available.

Analgesia and endocrine surgical stress: effect of two analgesia protocols on cortisol and prolactin levels during abdominal aortic aneurysm endovascular repair.

OBJECTIVES: Endovascular abdominal aortic aneurysm (AAA) repair was performed with local anaesthesia and intravenous analgesia. The objective of the study was to evaluate how two analgesia protocols affected stress response, measured as cortisol, 17-OH progesterone (17OHP) and prolactin (PRL) concentration during the procedure. METHODS: 44 patients undergoing elective AAA endovascular repair were included to either receive regular boluses of fentanyl midazolam or remifentanil continuous infusion, analgesia was monitored by Visual Analogue Scale (VAS) measurement; cortisol, 17OHP and PRL were sampled preoperatively, at skin incision, endovascular prosthesis release and skin suture. RESULTS: 42 patients were included. Mean VAS values were lower in the remifentanil group 0.50±0.68 vs 1.48±1.20, p=0.002 at incision, 0.24±0.58 vs 1.45±1.18, p<0.001 prosthesis release, 0.51±0.90 vs 1.73±1.45, p=0.002 suture. No statistically significant difference was found among cortisol and 17OHP levels; PRL was significantly lower in the fentanyl-midazolam group (23.83±16.92 ng/ml vs 40.81±22.45 p=0.009 at prosthesis release and 28.23±15.05 vs 41.37±14.54, p=0.007 at suture). CONCLUSIONS: Although statistically significant VAS difference had a limited clinical impact due to its small entity. The group that experienced less pain showed a more intense PRL response, while cortisol and 17OHP did not reach statistical significance.

Analgesia during abdominal aortic aneurysm endovascular repair: remifentanil vs. fentanyl-midazolam--a randomized controlled trial.

BACKGROUND AND OBJECTIVE: Endovascular repair offers a less surgically invasive procedure for abdominal aortic aneurysms but nevertheless, still requires analgesic sedative cover to ensure an acceptable level of patient comfort and cardiorespiratory stability. The peculiarity of this kind of operation is that painful stimuli are concentrated in specific moments separated by intervals devoid of pain, so the insurgence of pain can be predicted and prevented with a bolus of analgesic, making a continuous infusion not essential, but potentially useful in achieving a better analgesic stability. The primary objective of the study was pain control measured by Visual Analogue Scale; secondary endpoints were cardiorespiratory stability and an acceptable level of sedation. METHODS: The sedative analgesic protocols of two groups of randomly allocated patients, undergoing abdominal aortic aneurysm endovascular repair, were compared. The experimental group received remifentanil infusion (0.03-0.1 microg kg min) and the control group received intravenous doses of fentanyl and midazolam (1-3 microg kg and 0.05-0.1 mg kg, respectively). RESULTS: Fifty patients were investigated out of 60 enrolled. There were no relevant differences concerning cardiorespiratory stability and level of sedation, but pain levels were significantly lower in the experimental group: mean Visual Analogue Scale 0.35+/-0.40 vs. 1.49+/-0.62 (P<0.001) and area under the curve 17.48+/-5.09 vs. 33.05+/-8.19 (P<0.001). CONCLUSION: Both techniques were shown to be safe and most importantly effective in offering cardiovascular stability and analgesia for American Society of Anaesthesiologists III-IV patients undergoing endovascular abdominal aortic aneurysm repair. However, remifentanil continuous infusion proved to offer significantly more stable pain control compared with the currently used combination fentanyl-midazolam.

Design of a sensorized guiding catheter for in situ laser fenestration of endovascular stent.

PURPOSE: The in situ fenestration of a standard endograft is currently limited by difficulties in targeting the fenestration site under fluoroscopic control and by the lack of a safe method to perforate the graft. Evidence in the literature suggests the use of a 3 D electromagnetic navigator to accurately guide the endovascular instruments to the target and a laser to selectively perforate the graft. The aim of this work is to provide design guidelines to develop a sensorized catheter to guide the laser tool to the fenestration site and conduct preliminary testing of the feasibility of the proposed solution. Matherials and methods: Different catheter designs were delineated starting from engineering considerations, then prototypes were preliminarily tested to collect surgeon opinions and to steer the design process toward the preferred solution reported by the user. Finally, mechanical simulations were performed with CathCAD, a design software system for the development of composite tubing for endovascular catheters. RESULTS: Based on surgeon feedback, a 9-French steerable catheter with a stabilization system was designed. CathCAD simulations allowed us to define the construction parameters (e.g., materials and geometric constrains) for the fabrication of composite tubes with mechanical properties (flexural, axial, and torsional rigidities) compatible with target values in the literature for guiding catheters. CONCLUSION: The presented results preliminarily demonstrate the clinical reasonability and feasibility of the designed tool in terms of mechanical properties. Further mechanical tests and extensive in vitro clinical trials are required prior to animal testing.