Thoracoabdominal aneurysm repair using the Unitary Manifold Device.

OBJECTIVE: To present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of a thoracoabdominal aortic aneurysm with the physician-modified, nonanatomic-based Unitary Manifold (UM) device. METHODS: Data were collected from 126 consecutive all-comer patients treated with the physician-modified, nonanatomic-based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption G140207. RESULTS: The UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of a spinal cord event. Patients with a thoracoabdominal aortic aneurysm were categorized by Crawford classification: types I and V (3.3%, n = 4), type II (3.3%, n = 4), type III (1%, n = 1), and type IV (93.3%, n = 117). The type IV classification patients were further categorized with 33 (28.2%) true type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n = 125). The most common major adverse event within both 30 days and 365 days of all patients was respiratory failure (11.9%, n = 15, and 13.5%, n = 17, respectively). One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n = 7). Of the 444 branches stented, the primary patency rate was remarkably high as only three patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (≥5 mm) occurred in 1.6% (n = 2) patients, and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5), whereas all-cause mortality was 16.7% (n = 21). Physician-modified endograft device integrity failure was not observed in any patient. CONCLUSIONS: The UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison with other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies.

Single-Site Review of Spinal Cord Protection Protocols Including the Utilization of Spinal Drains versus Medical Management with Branched Endovascular Aortic Repair.

BACKGROUND: Spinal cord ischemia (SCI) continues to be a devastating complication after repair of thoracoabdominal aortic aneurysms. The objective of this review is to present our single-center outcomes after the implementation of a standardized neuroprotective protocol following branched endovascular aortic repair. METHODS: A standardized neuroprotective protocol including preoperative steroids, acetazolamide, intraoperative hemodynamic parameters, and postoperative treatment goals was initiated in November 2019. Physician-modified branched endovascular repairs were completed at a single center from 2012 to 2021 with outcomes reviewed both before (n = 107) and after (n = 67) the implementation of the neuroprotective protocol. The primary end point was the incidence of any SCI event at 30 days. Secondary end points included all-cause mortality, stroke, myocardial infarction, and renal failure at 30 days. Patients with Crawford extents I-III, renal failure, or necessitating emergent repair were deemed high risk for SCI events and underwent a subset analysis. Survivability after SCI was estimated using Kaplan-Meier tables. RESULTS: Of the 174 consecutive patients treated, the 67 patients treated following implementation of the neuroprotective protocol were more likely to have experienced a prior myocardial infarction (26.9% vs. 14%; P = 0.0466) and have a history of chronic obstructive pulmonary disease (64.3% vs. 45.8%; P = 0.02). This group was more likely to be treated for paravisceral aneurysms (53.7% vs. 24.3%; P = 0.0002). Postprotocol implementation, spinal drain use was lower (6% vs. 38.3%; P = <0.0001) with 100% of these drains placed in urgent or unstaged thoracoabdominal aortic aneurysm repairs as a part of the protocol. Rates of any SCI event among all patients before and after implementation of the protocol were 9.3% (n = 10 of 107) and 6% (n = 4 of 67; P = 0.57), respectively. In comparison, the protocol significantly reduced SCI rates to 0 (0% vs. 17.1%; P = 0.0407) in high-risk patients. Frequency of renal failure was reduced (3% vs. 14%; P = 0.018) after initiation of the protocol. Patients in the postprotocol group had significantly improved 1-year mortality rate (9% vs. 27.1%; P = 0.0035) and renal failure rates (2% vs. 15%; P = 0.018). Regression models indicated that patients in the postprotocol group had lower likelihood of mortality and renal failure than patients in preprotocol group (P < 0.05) and that spinal drain reduced mortality (P < 0.1). CONCLUSIONS: Implementation of a standardized neuroprotective protocol that focuses on medical management and fluid dynamics may significantly reduce risk of SCI after branched endovascular repairs, with the most significant improvement of SCI outcomes involving those at greatest risk for developing SCI. Also noteworthy, there was significant improvement to 1-year survivability after the implementation of this neuroprotective protocol.

Treatment of Thoracoabdominal Aortic Aneurysmal Degeneration Following Aortic Dissections at a Single Surgical Center Using a Physician-Assembled Branched Endovascular Stent Graft.

BACKGROUND: Aneurysmal degeneration of aortic dissection portends significant morbidity and mortality consequences in the subacute and chronic phases of aortic dissection. This article describes the use of a multibranched stent graft system for the treatment of thoracoabdominal aneurysmal degeneration of dissections with visceral segment involvement and reports upon the 30-day and 1-year outcomes for the first 18 patients treated with this design configuration. METHODS: The in-hospital, 30-day and 1-year morbidity and mortality outcomes of 18 consecutive patients treated with the physician-assembled visceral manifold or unitary manifold stent graft systems between 2013 and 2022 were evaluated. RESULTS: A total of 18 patients were treated for aneurysmal changes after aortic dissection. A total of 71 visceral vessels were successfully stented. There were no acute procedural failures. There were no episodes of paraplegia, reinterventions for type I or III endoleaks, patency-related events or mortalities reported in the first 30 days following treatment. One-year, all-cause mortality demonstrated 2/11 (18.2%). CONCLUSIONS: The aneurysmal degeneration of aortic dissection poses significant risks to patients with medically managed aortic dissections and those under surveillance. When these aneurysms develop in the thoracoabdominal region, treatment becomes even more challenging given the problem of visceral vessel patency, as these vessels can originate off the true or false lumens. The physician-designed endovascular stent graft system reported upon here has been successfully deployed in 18 patients with no acute procedural failures and promising clinical results. This treatment modality may offer utility to vascular surgeons whose patients with thoracoabdominal aneurysmal degeneration following aortic dissection have historically had limited endovascular repair prospects.