Early experience with patient-specific unibody bifurcated fenestrated-branched devices for complex endovascular aortic aneurysm repair.

OBJECTIVE: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR. METHODS: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. RESULTS: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm2 (IQR, 105-194 mGy∗cm2). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. CONCLUSIONS: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices.

Fiber Optic RealShape imaging using upper extremity and transfemoral access for fenestrated-branched endovascular aortic aneurysm repair.

We report our initial experience using Fiber Optic RealShape (FORS), an innovative real-time three-dimensional visualization technology that uses light instead of radiation, to achieve upper extremity (UE) access during fenestrated/branched endovascular aortic aneurysm repair (FBEVAR). An 89-year-old male patient with a type III thoracoabdominal aortic aneurysm, unfit for open aortic repair, underwent FBEVAR. Dual fluoroscopy, intravascular ultrasound, and three-dimensional fusion overlay were used, in addition to FORS. All target artery catheterizations were successfully accomplished using FORS, from UE access, without radiation. Our experience demonstrates that FBEVAR with FORS using UE access can be used for target artery catheterization without radiation.

Selective Versus Routine Spinal Drain Use for Fenestrated/Branched Endovascular Aortic Repair (F-BEVAR).

BACKGROUND: Spinal drains are used to ameliorate spinal cord ischemia (SCI), but their use may result in inherent morbidity and mortality. Although prophylactic spinal drain has proven of benefit in open repairs, that is not the case for endovascular repairs. The aim of this study was to assess the outcomes of spinal cord protection with and without the routine use of spinal drains during fenestrated-branched endovascular repair (F-BEVAR). METHODS: A retrospective single center study was performed using a prospectively maintained dataset of all patients undergoing F-BEVAR over a 4-year period. The primary endpoint of the study was the frequency of SCI. Prophylactic spinal drain was placed pre-operatively in 33 patients (23%) with a median time for removal of 3 days (IQR, 2-3 days). Routine intraoperative neuromonitoring was used. Spinal cord protection relied primarily on maintaining a perioperative systolic blood pressure between 140 and 160 mm Hg or a mean arterial pressure >90 mm Hg, avoiding hypotension, preservation of as many collateral beds as possible, staged repairs and early lower extremity reperfusion based on neuromonitoring. RESULTS: A total of 145 patients, 104 men (71%) and 41 women (28%) with a median age of 70 years (interquartile range [IQR], 53-62) underwent F-BEVAR. Branched custom-made devices (CMDs) (11%), fenestrated CMDs (70%) and off-the-shelf T-Branch device (17%) were used with a median number of branches/fenestrations of 4 (IQR, 3-4). SVS classification of implantation zones were determined as follows: 9 (6%) zone 2, 21 (20%) zone 3, 26 (18%) zone 4 and 89 (61%) zone 5. SCI was present in 8 patients (5.5%) and classified according to the SVS SCI grading system as follows: 1 grade 1, 5 grade 2 and 2 grade 3a. When evaluating implantation zone independently of coverage length and patency of collateral beds, a high implantation zone (1-4) was not associated with SCI (P = 0.9). Similarly, prophylactic spinal drain did not demonstrate association with the occurrence of SCI (3[9%] vs. 5[4%], with and without spinal drain, respectively) (P = 0.3). For patients with high implantation zones, staged repair was performed in 38 patients (26%) at a median time of 2 months (IQR, 2-6 months). Among these patients, the frequency of SCI was 13%. Staged repair was associated with an 80% reduction in the frequency of SCI (OR, 0.19 [95% CI, 0.04-0.084]) (P = 0.02). CONCLUSION: F-BEVAR can be performed with a minimal risk of SCI without the need for routine prophylactic spinal drains. High implantation zones did not predict SCI after F-BEVAR; however, staged repair significantly decreased the risk of SCI after F-BEVAR.

Dual fluoroscopy with live-image digital zooming significantly reduces patient and operating staff radiation during fenestrated-branched endovascular aortic aneurysm repair.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (F/B-EVAR) is a complex procedure that generates high radiation doses. Magnification aids in vessel cannulation but increases radiation. The aim of the study was to compare radiation doses to patients and operating room staff from two fluoroscopy techniques, standard magnification vs dual fluoroscopy with live-image digital zooming during F/B-EVAR. METHODS: An observational, prospective, single-center study of F/B-EVAR procedures using Philips Allura XperFD20 equipment (Philips Healthcare, Amsterdam, The Netherlands) was performed during a 42-month period. Intravascular ultrasound, three-dimensional fusion, and extreme collimation were used in all procedures. Intraoperative live-image processing was performed with two imaging systems: standard magnification in 123 patients (81%) and dual fluoroscopy with live-image digital zooming in 28 patients (18%). In the latter, the live "processed" zoomed images are displayed on examination displays and live images are displayed on reference displays. The reference air kerma was collected for each case and represents patient dose. Operating staff personal dosimetry was collected using the DoseAware system (Philips Healthcare). Patient and staff radiation doses were compared using nonparametric tests. RESULTS: Mean age was 71.6 ± 11.4 years. The median body mass index was 27 kg/m2 (interquartile range [IQR], 24.4-30.6 kg/m2) and was the same for both groups. Procedures performed with dual fluoroscopy with digital zooming demonstrated significantly lower median patient (1382 mGy [IQR, 999-2045 mGy] vs 2458 mGy [IQR, 1706-3767 mGy]; P < .01) and primary operator radiation doses (101 µSv [IQR, 34-235 µSv] vs 266 µSv [IQR, 104-583 µSv]; P < .01) compared with standard magnification. Similar significantly reduced radiation doses were recorded for first assistant, scrub nurse, and anesthesia staff in procedures performed with dual fluoroscopy. According to device design, procedures performed with four-fenestration/branch devices generated higher operator radiation doses (262 µSv [IQR, 116.5-572 µSv] vs 171 µSv [IQR, 44-325 µSv]; P < .01) compared with procedures with three or fewer fenestration/branches. Among the most complex design (four-vessel), operator radiation dose was significantly lower with digital zooming compared with standard magnification (128.5 µSv [IQR, 70.5-296 µSv] vs 309 µSv [IQR, 150-611 µSv]; P = .01). CONCLUSIONS: Current radiation doses to patients and operating personnel are within acceptable limits; however, dual fluoroscopy with live-image digital zooming results in dramatically lower radiation doses compared with the standard image processing with dose-dependent magnification. Operator radiation doses were reduced in half during procedures performed with more complex device designs when digital zooming was used.

Effects of preoperative visceral artery stenosis on target artery outcomes after fenestrated/branched endovascular aortic aneurysm repair.

OBJECTIVE: Target artery stenosis might affect the outcomes of fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The aim of the present study was to assess the effects of preoperative stenosis of the celiac artery (CA) and superior mesenteric artery (SMA) on the target artery outcomes after F-BEVAR. METHODS: During a 4-year period, 287 consecutive patients, 204 men (71%) and 83 women (29%), had undergone F-BEVAR using fenestrated (83%), fenestrated-branched (4.5%), branched (3.5%), and off-the-shelf t-Branch (9%) devices (Cook Medical Inc, Bloomington, Ind). Preoperative SMA and CA significant stenosis was defined as a computed tomography angiography-based intraluminal diameter reduction >50%. The primary endpoints included primary patency, freedom from target vessel instability, and patient survival. RESULTS: The median patient age was 71 years (interquartile range, 67-77 years). Suprarenal (36%), juxtarenal (25%), and thoracoabdominal (39%) aortic aneurysms were treated. The technical success rate was 99%. The 30-day survival was 97%. Among 981 stented vessels, 179 (18%) were CAs and 270 (27.5%) were SMAs. Significant preoperative CA stenosis was identified in 39 patients (22%) and SMA stenosis in 24 (9%). The median follow-up was 29.9 months. The primary patency rates at 12, 36, and 60 months were 98%, 92%, and 92% for the CA and 99%, 98%, and 98% for the SMA, respectively. Primary patency was significantly lower in the patients with previous significant CA stenosis than in those without stenosis (83%, 83%, and 76% vs 100%, 100%, and 97% at 12, 36, and 60 months, respectively; P < .01). Freedom from celiac branch instability was also significantly lower among patients with significant stenosis (84%, 84%, and 76% vs 100%, 93%, and 93% at 12, 36, and 60 months; P < .01). The presence of significant SMA stenosis did not affect either primary patency or freedom from target vessel instability. The survival rates at 12, 36, and 60 months were significantly lower for the patients with CA stenosis than for those without stenosis (67%, 61%, and 55% vs 90%, 84%, and 82%, respectively; P < .01). Similarly, lower survival rates were observed for patients with significant SMA stenosis (70%, 60%, and 60% vs 87%, 79%, and 78% at 12, 36, and 60 months, respectively; P = .04). CONCLUSIONS: F-BEVAR was associated with overall primary patency rates >90% for the CA and SMA. Preoperative CA stenosis was associated with lower primary patency and freedom from target vessel instability. In contrast, neither SMA branch primary patency nor freedom from target vessel instability were affected by preoperative SMA stenosis. We found visceral artery stenosis was a marker of atherosclerosis burden associated with reduced mid- and long-term patient survival.

Fenestrated-branched endovascular aortic repair in patients with chronic kidney disease.

OBJECTIVE: Renal function impairment is a common complication after open repair of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs). The purpose of this study was to assess renal perioperative outcomes and renal function deterioration after fenestrated-branched endovascular aneurysm repair (F/BEVAR) in patients with chronic kidney disease (CKD). METHODS: The study included 186 patients who underwent F/BEVAR between 2013 and 2018 for suprarenal, juxtarenal, and type I to type IV TAAAs. Glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) study equation. Postoperative acute kidney injury (AKI) and CKD were defined using RIFLE criteria (Risk, Injury, Failure, Loss, and End-stage renal disease) and CKD staging system (stage ≥3, GFR <60 mL/min/1.73 m2), respectively. For those without baseline CKD, renal decline was defined as a drop in GFR <60 mL/min/1.73 m2 (ie, progression to CKD stage 3 or higher). For patients with baseline renal dysfunction, GFR decline ≥20% or progression in CKD stage (ie, from stage 3 to stage 4) was considered renal decline. RESULTS: CKD was present in 83 patients (44.6%). Postoperative AKI was diagnosed in 27 patients (14.5%); 13 (48.1%) had history of CKD and 14 (51.9%) had adequate renal function preoperatively (P = .8). None of these patients required permanent renal replacement therapy. Intraoperative technical success was 100%. Overall 30-day mortality was 1.1%. There was no difference in 30-day mortality in patients with (1.2%) and without (1.0%) CKD (P = .5). During a median follow-up time of 12 months (interquartile range, 6-23 months), renal decline was observed in 21 patients (25.3%) with previous CKD and in 11 patients (10.6%) without CKD (P = .01). Among patients with previous CKD, 18 patients (9%) progressed from stage 3 CKD to stage 4. In patients with progression in CKD stage, two (5%) had renal stent stenosis requiring restenting. Among patients with renal decline, 13 had juxtarenal aneurysms (21.3%), 27 had suprarenal aneurysms (44.3%), and 21 had TAAAs (34.3%; P = .4). Subset analysis of patients who developed AKI in the immediate postoperative period found that patients with a history of CKD were less likely to experience freedom from renal decline. CONCLUSIONS: F/BEVAR is an effective and safe procedure for patients with complex abdominal aortic aneurysms and TAAAs, even among patients with CKD. The frequency of AKI was not affected by pre-existing CKD. Midterm outcomes demonstrated that progression of CKD was more frequent among patients with pre-existing CKD, but permanent renal replacement therapy was not required. Anatomic extent of aneurysms did not affect CKD progression. CKD patients are susceptible to renal decline over time if they experience AKI in the postoperative period. Therefore, preventing AKI in the postoperative period should be regarded as a priority. Long-term effects of CKD after F/BEVAR remain to be elucidated.

Gender and perioperative outcomes after fenestrated endovascular repair using custom-made and off-the-shelf devices.

BACKGROUND: The role of gender on perioperative outcomes after fenestrated endovascular aortic aneurysm repair (FEVAR) has not been established. The aim of this study is to determine the effect of gender on perioperative outcomes after FEVAR for complex abdominal aortic aneurysms using premanufactured devices. METHODS: During a 2-year period, 79 patients (63 men [80%] and 16 women [20%]) underwent FEVAR using Zenith Fenestrated AAA Endovascular Grafts, investigational Zenith pivot branch (p-branch) devices and fenestrated custom-made devices. A single-institutional study was performed to evaluate postoperative outcomes after FEVAR. The χ2, Fisher's, and nonparametric tests were used for bivariate analysis. Logistic regression was used for multivariate analysis. RESULTS: Median age was 73 years (interquartile range [IQR], 68-79 years). The median number of fenestrations was three. There was no difference in aneurysm anatomic location, size, or number of fenestrations between patients in either group. Women were more likely to undergo endoconduits at the access site before the target procedure (19% vs 2%; P = .02). The overall postoperative complication rate was similar among females and males (31% vs 33%; P > .5). However, women experienced longer times in the intensive care unit (median, 3 days [IQR, 2-5] vs 2 [IQR, 1-3]; P = .05) and longer duration of hospital stay (median, 4.5 days [IQR, 3-6.5] vs 3 [IQR, 2-4]; P < .01). Similarly, the rate of reinterventions was higher among women, 25% vs 5% (P = .02). For renal adverse events, there was a trend for a higher rate of renal function deterioration based in creatinine levels among women, when compared with men (18% vs 5%; P = .09). Multivariate analysis showed that female gender was associated with a 8-fold increased risk of renal function deterioration (odds ratio, 8.1; 95% confidence interval, 6.1-10.8). Female gender was also identified as in independent factor for reinterventions at 30 days (odds ratio, 7.4; 95% confidence interval, 6.7-8.1). CONCLUSIONS: FEVAR is a safe and effective procedure for patients at high and standard risk for open repair who are not eligible for standard EVAR. Women are at greater risk for more severe renal function deterioration, early reinterventions and longer durations of hospital and intensive care unit stay.