AbstractObjectiveHypogastric artery aneurysms (HAAs) are rare but life-threatening in cases of rupture. Open or endovascular techniques traditionally aimed at occluding the hypogastric artery (HA) ...have considerable risk of pelvic ischemia. Iliac branch devices (IBDs) are indicated for aortoiliac aneurysms; however, they have also been used lately for HAAs. Currently, there are no reports about patient outcomes focusing on HAA therapy using IBDs. We retrospectively analyzed early and midterm outcomes using IBDs for HAAs. MethodsPatients who received IBDs for HAAs at our department from January 1, 2012, through March 1, 2018, were included. Exclusion criteria were as follows: no HA involvement, emergency procedures, and HA stent grafting without IBD. Perioperative and follow-up data were collected from medical records. ResultsThere were 18 IBDs (only IBD, n = 4; IBD + endovascular aneurysm repair EVAR, n = 7; IBD ± EVAR + side branch occlusion, n = 7) implanted into 14 male patients (76 ± 4 70-83 years). There were no intraoperative complications, and the technical success rate was 100%. After 19 ± 11 (2-39) months of follow-up, two hybrid (external iliac artery occlusion, n = 1; EVAR graft kinking, n = 1) and four endovascular reinterventions due to two type IB (side branch coiling + stent graft extension) and two type IIIB (stent grafting) endoleaks were required. One IBD-related type II endoleak revealed constant aneurysm diameters during follow-up. One small type IB endoleak was self-limited. Estimated freedom from reintervention was 31% ± 23% at 2.7 years. The clinical success and patency rate was 100%. The IBD-related mortality was 0%. ConclusionsThe IBD for HAA shows good early and midterm results. Adequate sealing of HA landing zones and side branch occlusion are technically challenging but crucial to prevent type IB and type II endoleaks.
Objective This study examined effects and functional outcome of recombinant human erythropoietin (rhEPO) and carbamylated erythropoietin fusion protein (cEPO-FC) preconditioning in a rabbit model for ...spinal cord ischemia and resulting paraplegia. This model was chosen because only a small surgical effect is needed to cause paraplegia in rabbits, which facilitates postoperative observation of animals. Methods Anesthetized but spontaneously breathing New Zealand White rabbits randomly received cEPO-FC (50 μg/kg; n = 8), rhEPO (5000 IU/kg; n = 10), or vehicle (control; n = 10) 30 minutes before and after infrarenal aortic clamping. Ideal clamping time of 22 minutes was identified from preceding clamping tests (15-25 minutes). Postoperative observation time was 96 hours. Spinal cord function was assessed by neurologic evaluation of hind limb motor function every 12 hours using a modified Tarlov score. Spinal cord tissue damage was evaluated after 96 hours using hematoxylin and eosin, elastica van Gieson, Nissl, Masson-Goldner, and hemosiderin staining. Plasma levels of cell senescence markers stathmin, chitinase 1/3, elongation factor 1-α were determined. Results Rabbits that received rhEPO showed significant improvement of spontaneous lower limb movements until 36 hours of reperfusion and improved histologic scores upon examination of the lumbar spinal cord compared with the control group. In contrast, cEPO-FC treatment showed comparable outcome to the control group concerning movements of the lower limbs and histology. Senescence markers were elevated in the control group, but not in the treatment groups, except for chitinase 3 in the rhEPO group. Only stathmin showed no significant effect. Markers for senescence might increase after acute ischemic injury. Attenuation of senescence markers might not come alone from improvement of the spinal cord. Conclusions Preconditioning with rhEPO attenuates ischemia/reperfusion injury of the spinal cord, whereas the carbamylated derivative (cEPO-FC) showed no positive effect on spinal cord function.
Objective This study evaluated the changes of the aortic diameter at the suprarenal and infrarenal segment after open repair (OR) and endovascular repair (EVAR) of abdominal aortic aneurysms (AAAs). ...Methods This was a retrospective analysis of all patients undergoing AAA repair between 1997 and 2008. Inclusion criteria were at least 3 months of follow-up at our institution, elective aneurysm repair, and absence of false, mycotic, or inflammatory aneurysms. For EVAR, standard computed tomography (CT) scans from follow-up were used; in the OR group, CT scans performed for unrelated nonvascular indications were used. Diameters of the aorta were measured at the first slice below the lowest renal artery and at the first slice above the highest renal artery. A 2-mm change was defined as measurable aortic neck dilatation. Results Inclusion criteria were met by 46 patients in the OR group and 103 in the EVAR group. After a follow-up of 34.1 months (range, 5.5-131.7 months) in the OR group and 39.4 months (range, 3-108.9 months) in the EVAR group, the mean changes were 1.75 ± 3.50 mm (OR) and 0.9 ± 2.3 mm (EVAR; P = .305) in the suprarenal diameters and 0.8 ± 2.9 mm (OR) and 1.2 ± 2.5 mm (EVAR; P = .311) in the infrarenal diameters. The absolute suprarenal vs infrarenal sizes were 29.7 ± 7.1 and 28.7 ± 6.8 mm in the OR group and 28.7 ± 3.2 and 28.5 ± 3.6 mm, respectively, in the EVAR group (suprarenal, P = .749; infrarenal, P = .273). Increase of the aortic diameter >2 mm, defined as aortic neck dilatation, was found in 23 of 103 EVAR patients (22.3% ± 0.862%), and in nine of 46 OR patients (19.57% ± 0.484%; P = .870). Increase in the suprarenal change >2 mm occurred in 21 of 103 EVAR patients (20.39% ± 1.04%) and in 14 of 46 OR patients (30.4% ± 0.446%; P = .260). Reintervention rate of patients with an increase >2 mm was 31% (seven of 23) in EVAR and 11.1% (one of nine) in the OR group ( P = .386). Conclusions The AAA groups treated with EVAR or OR demonstrated similar increases of aneurysmal neck diameters. This suggests that aortic neck dilatation may be caused by a natural progression of the disease rather than by deviating therapeutic strategies.
Objective Analysis of in-hospital outcomes in patients treated for critical limb ischemia (CLI) and end-stage renal disease (ESRD) compared to CLI patients with normal renal function. Methods A ...subgroup analysis of the German CRITISCH registry, a prospective multicenter registry, assessing the first-line treatment strategies in CLI patients in 27 vascular centers in Germany was performed. The study cohort was divided into ESRD patients (n = 102) and patients with normal renal function (n = 674; glomerular filtration rate >60/mL/min/1.73 m2 ). The following first-line treatment strategies were assessed: endovascular therapy (EVT), bypass surgery, patch plasty, and no vascular intervention (conservative treatment, primary amputation). Uni- and multivariate analyses were performed to identify differences between groups as to six end points: amputation or death (composite end point), amputation, death, hemodynamic failure, major adverse cardiac and cerebrovascular events, and reintervention. Results Differences between the ESRD and non-ESRD group were found regarding the applied first-line therapy ( P = .016): The first-line treatment strategies in ESRD patients were EVT in 64% (n = 65), bypass surgery in 13% (n = 13), patch plasty in 11% (n = 11), and no vascular intervention in 13% (n = 13). In non-ESRD patients, EVT was applied in 48% (n = 326), bypass surgery in 27% (n = 185), patch plasty in 13% (n = 86), and no vascular intervention in 11% (n = 77). For ESRD patients, a noticeably increased risk of the composite end point (odds ratio OR, 2.62; 95% confidence interval CI, 1.19-5.79; P = .017), amputation (OR, 3.14; 95% CI, 1.35-7.31; P = .008), and hemodynamic failure (OR, 2.19; 95% CI, 1.19-4.04; P = .012) was observed. Conclusions CLI patients on dialysis represent a challenging cohort prone to in-hospital death, amputation, and hemodynamic failure. Two-thirds of these high-risk patients are treated with EVT. Present data suggest that this modality is generally considered as the most favorable treatment option in this patient subgroup.
Objective To analyze early technical success and late clinical success after endovascular entry sealing for chronic type B dissection with special emphasis on reintervention, false lumen thrombosis, ...and aortic remodeling. Methods Retrospective analysis of a prospective database. From September 1999 to January 2011, 19 patients with chronic type B dissections were treated by endovascular entry sealing. Median age was 60 years. Median time between onset of acute dissection and surgical intervention was 36 (1 to 60) months. Median follow-up was 13 months (1 to 124). Results The endografts used were: Medtronic Captivia (5), Medtronic Valiant (5), Gore TAG (6), Gore C-TAG (2), and Cook Zenith (1). In four patients, revascularization of the left subclavian artery was performed prior to entry sealing. Primary technical success rate (entry sealing, absence of type I leak) was 18/19 (94.7%). In-hospital mortality was 0%. Spinal cord injury with persistent paraplegia occurred in 1/19 (5.2%) patients. After a maximal follow-up of 124 months, reinterventions in 9/19 (47.3%) were necessary: distal/proximal extension of stent graft (8), replacement of the aortic arch due to retrograde dissection (1), and open infrarenal aneurysm repair (1). During follow-up, none of the patients died due to stent-related complications. Conclusion Endovascular treatment (EVT) in chronic type B dissections has a high technical success rate and low mortality/morbidity. However reintervention rates are not negligible which might reduce the clinical success of EVT. Future investigations should aim at identifying patients who benefit from EVT at better defining the timing of EVT and at determining if entry sealing alone is sufficient.
Background This study used magnetic resonance imaging (MRI) to analyze functional long-term outcome after endovascular repair of blunt aortic injury. Methods This prospective study enrolled 27 of 53 ...patients who were treated between 1999 and 2008. Patients underwent functional multidimensional contrast-enhanced MRI with flow analysis or compliance measurements of the aorta, or both. Ten patients were treated with the Medtronic Valiant (Medtronic World Medical, Sunrise, Fla), 14 patients received a Gore TAG (W. L. Gore & Associates, Flagstaff, Ariz), and two received a C (conformable)-TAG (W. L. Gore & Associates) stent graft. For several patients, repetitive measurements over time could be done. Median follow-up was 3.92 ± 2.7 years. The MRI parameters were: three-dimensional flow: echo time/repetition time = 3.1/5.3 ms, Δx(pixel density) = 2.5 × 2.5 × 3 mm3 ; respiratory navigator, α = 15°, venc (encoding velocity) = 200 cm/s along anterior-posterior, right-left, and foot-head direction, 40 cardiac phases. Cine: echo time/repetition time = 1.7/3.4 ms, Δx(pixel density) = 1.2 × 1.2 × 6 mm3 , breathhold, α = 60°, 40 cardiac phases. Results The flow analysis showed flow acceleration at the proximal end of the stent graft, with higher values in patients with a nonoptimal alignment of the stent graft. No differences were found between different devices (median acceleration was 75.99 ± 37.98 cm/s for Gore and 71.59 ± 17.22 cm/s for Medtronic). The values were stable during follow-up. In the compliance analysis, the part of the aorta covered with the stent graft showed nearly no expansion, whereas the ascending and descending aorta showed normal expansion. This behavior did not change over the time. At the proximal end of the stent graft, a slight compression could be noted (−0.5 ± 0.14 mm), except in those patients with a C-TAG device from Gore. Conclusions Functional analysis showed no adverse long-term outcome of the bird beak configuration of stent grafts in the aortic arch after endovascular repair after blunt aortic injury.
Objective Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal ...treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. Methods Between January 2013 and September 2014, five first-line treatment strategies—endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation—were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model. Results The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment ( P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio OR, 2.96; 95% confidence interval CI, 1.42-6.17) and previous myocardial infarction (PMI) <6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0). Conclusions The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI <6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.
Abstract Objective The aim of this study was to investigate the 1-year safety and efficacy of a new iliac side-branched device (IBD) for revascularization of the hypogastric arteries. Methods ...Patients receiving the E-liac (Jotec GmbH, Hechingen, Germany) side-branched device at six German vascular centers either as a stand-alone procedure or in combination with abdominal aortic aneurysm exclusion were included in a prospectively created data bank. Collected data were analyzed for baseline characteristics, procedural events, and clinical follow-up; variables included endoleaks, reinterventions, and internal iliac artery (IIA) patency. Results Between January 2012 and January 2015, a total of 70 patients (69 men 98.6%) with a median age of 74 years (range, 51-87 years) were consecutively treated; 66 patients had aneurysmatic disease of the iliac arteries, 2 patients had a para-anastomotic aneurysm after aortobi-iliac reconstruction, and another 2 patients had a type Ib endoleak after endovascular aneurysm repair. A total of 82 IIAs were revascularized, 12 bilaterally. Technical success was achieved in 100% (82/82) of the revascularized IIAs. All IBDs were patent at the end of the procedure. No instances of myocardial infarction, stroke, conversion to open repair, mesenteric or spinal cord infarction, or buttock necrosis were observed. There was one perioperative death (1.4%) in a 70-year-old patient with intraoperative gastrointestinal bleeding leading to multiple organ failure, which resulted in the patient's death on the fifth postoperative day. Within 30 days, one symptomatic occlusion of a treated common iliac artery (CIA) was observed. In two other patients, an asymptomatic kinking of the CIA segment of the IBD was revealed in the predischarge follow-up duplex ultrasound examination and corrected with relining. Median follow-up was 12 months (range, 6-16 months). One patient was lost during the follow-up period. Survival at 1 year was 98.5% with all IIAs remaining patent, whereas two CIA and two external iliac artery limb occlusions occurred. According to life-table analysis, the freedom from occlusion in a patient was 92% at 1 year, and freedom from type I endoleak was 87% at 1 year. Conclusions This first ever 1-year study reports the results with the new E-liac device and shows that it can be safely applied for the treatment of aortoiliac aneurysmatic disease with low reintervention rates and high patency rates. Long-term data are needed to confirm the durability of the device.
Abstract Objectives The most effective first-line treatment between endovascular therapy and bypass surgery for patients with critical limb ischemia (CLI) is still not well defined. The primary aim ...of the interim analysis of CRITISCH (Registry of First-Line Treatments in Patients With Critical Limb Ischemia) was to compare both treatment options in a prospective confirmatory manner. Background Only 1 randomized controlled trial between endovascular therapy and bypass surgery has been published yet. Several retrospective studies showed comparable outcomes between the 2 treatment strategies, but in the majority of them, current endovascular technologies have not been included. Methods Between January 2013 and September 2014, 1,200 CLI patients (Rutherford 4 to 6) from 27 vascular centers were enrolled. The selection of the first-line treatment was left completely to the discretion of the responsible physician. The primary composite endpoint was amputation-free survival (AFS), that is, time to major amputation and/or death from any cause. A pre-specified interim analysis aimed at showing noninferiority of the endovascular therapy versus bypass surgery as to the hazard ratio (HR) of AFS (noninferiority bound = 1.33; interim α = 0.0058). Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results Endovascular therapy was applied to 642 (54%) and bypass surgery to 284 (24%) patients. Median follow-up time was 12 months in both groups. One-year AFS was 75% and 72%, respectively. The noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed (HR: 0.91; upper bound of 1-sided (1 − 0.0058) confidence interval CI: 1.29; p = 0.003). An impact of the treatment strategy on time until death (HR: 1.14; 95% CI: 0.80 to 1.63; p = 0.453), major amputation (HR: 0.86; 95% CI:0.56 to 1.30; p = 0.463), and reintervention and/or above-ankle amputation (HR: 0.89; 95% CI: 0.70 to 1.14; p = 0.348) was not observed. Conclusions The interim analysis confirmed that when physicians are free to individualize therapy to CLI patients, the endovascular-first approach achieved a noninferior AFS rate compared with bypass surgery. (Registry of First-Line Treatments in Patients With Critical Limb Ischemia CRITISCH; NCT01877252 )
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