Prospective randomized pilot trial comparing prophylactic and therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.

OBJECTIVE: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies. METHODS: We used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences. RESULTS: A total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits. CONCLUSIONS: The overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop.

Rationale of the PAPAartis trial.

Surgical and interventional repair of thoracoabdominal aortic aneurysms improve survival significantly compared to the natural history of the disease. However, both strategies are associated with a substantial risk of spinal cord ischemia, which has been reported to occur-even in contemporary series by expert centers-in up to 12% of patients, depending on the extent of the disease. Following improved neurological outcomes after staged approaches in extensive clinical and long-term large animal studies, and the description of the "collateral network", the concept of "Minimally Invasive Staged Segmental Artery Coil Embolization" (MIS2ACE) was introduced by Etz et al. This concept of priming the collateral network in order to improve spinal cord blood supply showed promising experimental and early clinical outcomes, and consequently led to the initiation of the randomized controlled multicenter PAPAartis trial (Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging). This Keynote Lecture describes the background and rationale for this trial and gives an update on the current status.

Open, closed or a bit of both: a systematic review and meta-analysis of staged thoraco-abdominal aortic aneurysm repair.

Background: Staged procedures are one strategy found to be beneficial for medium- to high-risk Crawford extent I-III thoraco-abdominal aortic aneurysm (TAAA) repair patients and may be performed through a variety of techniques. This review sought to compare the primary outcomes of spinal cord ischemia (SCI) and long-term mortality between three cohorts grouped by approach: open, endovascular, and hybrid. Methods: In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a total of 919 references were extracted from a search of three online databases (Embase, PubMed, Scopus). Following application of inclusion/exclusion criteria and data extraction, quantitative meta-analysis was undertaken utilizing a random effects model. Kaplan-Meier (KM) curves were digitized and aggregated to graph estimated survival. Results: A total of 20 studies representing 924 patients were included. SCI was highest in the endovascular group, at 9.8% of weighted means, followed by hybrid, and open groups at 3.2% and 1.4%, respectively. However, 30-day mortality was highest in the open group at 6.0%, followed by the hybrid group at 3.8%, and endovascular at 3.6%. Aggregated long-term survival estimations are shown graphically, extending to 5 years for open and endovascular cohorts, and 3 years for the smaller hybrid cohort. Conclusions: While all cases incorporated spinal drainage, monitoring and staging for spinal protection, there is innate difference in approach when examining for cord ischemia. This systematic review and meta-analysis of staged TAAA repair describes the first comparison between cohorts of open and endovascular approach, revealing the increased risk of SCI and long-term mortality in endovascular repair.

Prophylactic cerebrospinal fluid drainage and spinal cord ischemia in thoracic and thoracoabdominal endovascular procedures: a systematic review and meta-analysis.

Background: Spinal cord ischemia (SCI) is one of the most devastating complications of thoracic endovascular aortic repair (TEVAR). Prophylactic cerebrospinal fluid drainage (CSFD) has been shown to decrease the risk of SCI in open thoracic aortic procedures; however, its utility in TEVAR remains uncertain. This systematic review and meta-analysis aim to determine the role of prophylactic CSFD in preventing SCI in TEVAR. Methods: A literature search of five databases was performed and all studies published before September 2022 that reported SCI rates in TEVAR patients undergoing prophylactic CSFD were included. A random effects meta-analysis of means or proportions was performed for single-arm data. Odds ratios (ORs) with 95% confidence intervals (CIs) were reported for comparisons between groups. Results: A total of 4,793 patients undergoing TEVAR from 40 studies were included. The mean age was 68.8 years and 70.9% of patients were male. The overall SCI rate was 3.5%, with a 1.3% rate of immediate SCI and a 1.9% rate of delayed SCI. There were no significant differences in SCI rates between prophylactic CSFD patients and non-drained patients. Routine CSFD did not have a significant impact on SCI rates compared to non-drained patients. There was an increased rate of transient SCI with selective CSFD compared to non-drained patients (OR 2.08; 95% CI: 1.06-4.08; P=0.03). The most common drain-related complication was spinal headache (4.3%). The major complication rate was 1.6%, of which epidural or spinal hematoma (0.9%) was the most common, followed by intracranial or subdural hemorrhage (0.8%) and paraparesis or paraplegia (0.8%). Conclusions: This study found no significant difference in SCI rates between prophylactic CSFD patients and their non-drained counterparts. CSFD is associated with a small but non-negligible risk of serious complications. Multi-center randomized controlled trials (RCTs) are warranted to help stratify the risk of both SCI and CSFD-related complications in patients undergoing endovascular aortic procedures.

Paraspinal muscle claudication after fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

Fenestrated-branched endovascular repair of thoracoabdominal aneurysms carries a risk of spinal cord ischemia owing to extensive coverage of intercostal arteries, but other consequences of decreased flow to the paraspinal muscles have not been delineated. We describe a 54-year-old woman treated by multibranched thoracoabdominal aneurysm repair who developed severe disabling exertional thoracic and lumbar back pain after the operation. Despite physical therapy, the patient remains with disabling symptoms at 2 years of follow-up. Transcutaneous oxygen pressures confirmed exercise-induced decrease in oxygen pressure, consistent with decreased muscle perfusion. We propose the term paraspinal muscle claudication to describe these symptoms.

Neurological complications after thoracic endovascular aortic repair. Does the left subclavian artery coverage without revascularization increase the risk of neurological complications in patients after thoracic endovascular aortic repair?

INTRODUCTION: One of the most severe complications after TEVAR is ischemic stroke and spinal cord ischemia (SCI) resulting in severe disability. These complications can be fatal up to 30% of cases, so it is very important to define risk factors associated with the occurrence of such events. The aim of this study was to define the causes and risk factors associated with the occurrence of neurological complications in patients after TEVAR. MATERIALS AND METHODS: We performed a retrospective analysis of 51 patients undergoing TEVAR in the Department of Vascular Surgery of Military Teaching Hospital in Wroclaw between 2014 and 2017. In 18 patients LSA coverage was managed without revascularization (35.29%), and in 33 patients LSA remained uncovered (64.71%). RESULTS: We did not find any statistically significant difference in the incidence of stroke and spinal cord ischemia in patients with covered and uncovered LSA (stroke p = 0.37, SCI p = 0.58). In the group of patients with covered and uncovered LSA, we did not find any significant differences in the incidence of additional comorbidities such as obesity, ischemic heart disease, hypertension or previous stroke. CONCLUSIONS: There is no difference in stroke and SCI occurrence between patients with covered and uncovered LSA. Although there are many studies analysing the risk of such complications, there is no specific consensus regarding the treatment of LSA coverage. Randomised clinical trials on a large group of patients are still needed.

Risk of spinal cord ischemia after thoracic endovascular aortic repair.

BACKGROUND: Spinal cord ischemia (SCI) is a recognized grave complication after thoracic endovascular aortic repair (TEVAR). The present study aimed to evaluate the incidence and investigate risk of SCI after TEVAR based on current prophylactic strategies designed against established risk factors. METHODS: The study retrospectively reviewed a prospectively maintained database to investigate patients who underwent TEVAR successfully between January 2009 and December 2012 in a single cardiovascular center. Detailed assessment of SCI risk was routinely performed for all patients before TEVAR was carried out. Prophylactic measures, including left subclavian artery (LSA) revascularization, blood pressure augmentation and cerebrospinal fluid (CSF) pressure control after TEVAR, were employed in high-risk patients and physical neurological examinations were regularly done to evaluate SCI after TEVAR. Patients were further divided into SCI group and non-SCI group. RESULTS: A total of 650 patients were enrolled in the study. Eleven patients (1.69%) developed SCI after TEVAR. Baseline level of hemoglobin was significantly lower in the SCI group (113.00 vs. 128.50, P=0.023). More patients in the SCI patients in the SCI group underwent TEVAR under general anesthesia (45.5% vs. 17.7%, P=0.033). A significantly higher incidence of post TEVAR hypotension was found in the SCI group (2.7% vs. 27.3%, P=0.004). Logistic regression analysis revealed that post-TEVAR hypotension (OR, 8.379; 95% CI, 1.833-38.304; P=0.006) was strongly associated with development of SCI and high normal baseline hemoglobin was a protective factor (OR, 0.969; CI, 0.942-0.998; P=0.037). The mortality in hospital and mortality at 1 year were not significant different between the SCI and the non-SCI group (0% vs. 1.6% P=1.000; 9.1% vs. 3.0%, P=0.294, respectively). While length of post-TEVAR stay (13.00 vs. 7.00 days, P=0.000) and length of hospital stay (20.00 vs. 13.00 days, P=0.001) were significantly greater in the SCI group. CONCLUSIONS: Our study revealed that, based on current prophylactic measures to curtail SCI, including LSA revascularization, blood pressure augmentation and CSF pressure control after TEVAR, post-TEVAR hypotension remains a major and independent risk factor for SCI and high normal baseline hemoglobin level is protective. SCI results in longer post-TEVAR stay and hospital stay, but not associated with increased mortality. Robust precautions should be taken against underlying causes for post-TEVAR hypotension and low level of hemoglobin should be avoided.