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 (TAAA). 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 (RCT) designed to investigate the role of prophylactic versus 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 branched and fenestrated endovascular aortic aneurysm repair (FBEVAR) for extensive thoracoabdominal 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 spinal cord ischemia. 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%), 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 spinal cord ischemia 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 (GI) 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 versus therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.