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.

Incidence of Acute and Chronic Renal Failure Following Branched Endovascular Repair of Complex Aortic Aneurysms.

BACKGROUND: The purpose of this study was to examine the incidence of acute kidney injury and chronic renal impairment following branched endovascular aneurysm repair (BEVAR) of complex thoracoabdominal aortic aneurysms (TAAA) using the Medtronic Valiant Thoracoabdominal Aortic Aneurysm stent graft system (MVM), the physician-modified Visceral Manifold, and Unitary Manifold stent graft systems. The objective was to report the acute and chronic renal function changes in patients following complex TAAA aneurysm repair. METHODS: This is an analysis of 139 patients undergoing branched endovascular repair for complex TAAAs between 2012 and 2020. Patient renal function was evaluated using serum creatinine and estimated glomerular filtration rate at baseline, 48 hr, discharge, 1 month, 6 months, and annually to 2 years. Patients on dialysis prior to the procedure were excluded from data analysis. RESULTS: A total of 139 patients (mean age 71.13; 64.7% male) treated for TAAA with BEVAR met inclusion criteria and were evaluated. A total of 530 visceral vessels were stented. A majority of patients (n = 131, 94.2%) underwent a single procedure while 8 required staged procedures. Thirty-day, 1-year and 2-year all-cause mortality rates were 5.8%, 25.2%, and 32.4%, respectively. Primary and secondary patency rates at a median follow-up of 26.9 months (95% CI; 21.1 - 32.7) were 96.2% and 97.5% for all vessels and 95.4% and 96.9% for renal arteries, respectively. Postoperative acute kidney injury (AKI) was identified in 22 (15.8%) patients. At discharge, 16 patients (11.6%) had an increase in CKD stage with 3 requiring permanent dialysis. Five additional patients required permanent dialysis over the 2-year follow-up period for a total of 8 (5.8%). Increasing age (HR = 1.0327, P= 0.0477), hemoglobin < 7 prior to procedure (HR = 2.4812, P= 0.0093), increasing maximum aortic diameter (HR = 1.0189, P= 0.0084), presence of AKI (HR = 2.0757, P= 0.0182), and increase in CKD stage (HR = 1.3520, P= 0.002) at discharge were significantly associated with decreased patient survival. CONCLUSIONS: Postoperative AKI and a chronic decline in renal function continue to be problematic in endovascular repair of complex aortic aneurysms. This study found that BEVAR using the manifold configuration resulted in immediate and mid-term renal function that is comparable to similar analyses of branched and/or fenestrated grafts.

Short-term Cost Comparison of Systemic Heparin Therapy vs. Catheter Directed Thrombolysis for the Treatment of Massive and Submassive Pulmonary Embolism with Long-Term Chronic Pulmonary Hypertension Cost Model.

INTRODUCTION: Pulmonary embolism (PE) is a significant disease process that affects an estimated 117 cases per 100,000 person-years. Chronic pulmonary hypertension (CPH) is a long-term complication associated with acute PE which has a significant cost to treat, ranging from $98,000-117,000. METHODS: A retrospective chart review of 341 patients from January 2011 to November 2018 who presented with massive or submassive PE and were treated with either systemic heparin therapy or catheter directed thrombolysis (CDT). The results of the short-term cost analysis and pulmonary hypertension rates from data collected was then used in a long-term cost model using a standardized 100 patient model. RESULTS: Treatment with CDT resulted in fewer bleeding complications (4.2 percent vs. 13.8 percent, p=0.005), a shorter length of stay, a greater percentage of patients returning to their prior living conditions (89.0 percent vs. 79.3 percent, p=0.042), and a lower rate of chronic pulmonary hypertension at 12 months (6.3 percent vs. 15.9 percent, p=0.030) than those treated with systemic heparin. The expense of treatment utilizing CDT was greater than those undergoing systemic heparin treatment with a difference of approximately $31,000 (p=0.001) though our cost model showed the heparin group to have a higher cost over time. CONCLUSIONS: For patients with massive or submassive PE, this study demonstrated a significant long-term cost savings and improved outcomes for patients treated with catheter directed thrombolysis when compared to systemic heparin administration.

Combination of mural thrombus and age improves the identification of all-cause mortality following branched endovascular repair.

BACKGROUND: In-hospital and 30-day mortality rates of endovascular repair of thoracoabdominal aortic aneurysms shows a significant improvement over open surgery, although we are not seeing a significant difference at 1 year. We assess the hypothesis that a greater mural thrombus ratio within the aorta could function as an indicator of postoperative mortality. METHODS: The mural thrombus ratio and preoperative comorbidities of 100 consecutive patients from a single center undergoing endo-debranching between 2012 and 2019 were evaluated. Logistic regression, survival analysis, and decision tree methods were used to examine each variable's association with death at 1 year. RESULTS: At the time of analysis, 73 subjects had 1-year outcomes and adequate imaging to assess the parameters. At 1 year, the overall survival for all subjects was 71.2% (21 died, 52 survived). For patients with a favorable mural thrombus ratio (n = 36), the overall 1-year survival was 86.1% (5 died, 31 survived). The subjects with an unfavorable mural thrombus ratio (n = 37), had an overall 1 year survival of 56.8% (16 died, and 21 survived). The only preoperative mortality factor that was statistically significant between the subjects with an unfavorable mural thrombus ratio was age of the patient. The survival for subjects 75 years and older with an unfavorable mural thrombus ratio was 90% (one died, nine survived) vs only 44.4% survival for subjects less than 75 years with an unfavorable mural thrombus ratio (15 died, 12 survived). CONCLUSIONS: This study examined whether a patient's mural thrombus ratio may be an indicator of 1-year survival. These findings suggest that the combination of a patient's aortic mural thrombus ratio and age can function as a preoperative indicator of their underlying cardiac reserve. Identifying patients with low cardiac reserve and fitness to handle the increased cardiac demands owing to the physiologic response to extensive aortic stent grafting before undergoing aortic repair may allow for modification of preoperative patient counseling and postoperative care guidelines to better treat this patient population.

A novel physician-assembled endograft for the repair of pararenal, paravisceral, Crawford type IV thoracoabdominal aortic aneurysms, and aneurysms requiring treatment after prior repair.

OBJECTIVE: In the present study, we reviewed the 30-day and 1-year clinical results of the use of the investigational unitary manifold (UM) stent graft system (Sanford Health, Sioux Falls SDak) for the repair of Crawford type IV, pararenal, paravisceral, juxtarenal, and short-neck infrarenal aneurysms (<10 mm). METHODS: The present study was a single-center, multiarm, prospective review of the first 44 patients who had undergone repair of Crawford type IV, pararenal, juxtarenal, and short-neck infrarenal aneurysms (<10 mm) using the physician-modified UM under a physician-sponsored investigational device exemption. The primary end point was freedom from major adverse events at 30 days, including all-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, and renal failure. RESULTS: Technical success was achieved in all 44 patients (100%), with a large number of these patients having undergone previous aortic repair (20 of 44; 45.5%). All the intended 170 visceral vessels (100%) had been successfully cannulated and stent grafted. No episodes of paraplegia or in-hospital deaths were recorded. One patient had died of aneurysm-related ischemic stroke (2.3%). The rate of transient nonclinically significant spinal cord ischemia was 4.5%. At the last follow-up, one reintervention had been required owing to branch patency from a thrombotic event. Of the 170 bridging stent grafts, 169 have remained patent through a mean follow-up of 8.8 months (range, 0-36 months). No type I or III endoleaks, migration, or component separation in the investigational device has occurred. CONCLUSIONS: The early and midterm results with the use of the UM suggest it could be a viable option for the repair of Crawford type IV, pararenal, paravisceral, juxtarenal, and short-neck infrarenal aneurysms (<10 mm) without exposing patients to the increased risk of permanent spinal cord ischemia, renal failure, visceral vessel ischemia, or aneurysm-related mortality that results from open thoracoabdominal aortic aneurysm repair. The high technical success rate, in native and previous repairs, supports the utility of this device as a bail-out technique for failed endovascular aneurysm repair or proximal extension of disease after previous aortic repair. However, experience is limited, and this approach requires further study before widespread adoption.

Safety and efficacy of ultrasound-accelerated catheter-directed lytic therapy in acute pulmonary embolism with and without hemodynamic instability.

OBJECTIVE: The objective of this study was to evaluate the safety and effectiveness of ultrasound-accelerated thrombolysis in acute pulmonary embolism. METHODS: A retrospective study of 45 patients was performed to evaluate treatment of acute pulmonary embolism at a single center from January 2011 to December 2013. All patients were diagnosed with computed tomography or ventilation-perfusion scan and had hemodynamic instability (systolic blood pressure <100 mm Hg) or right-sided heart strain evidenced by right ventricular dilation, septal deviation, or hypokinesis by echocardiography or computed tomography. EkoSonic catheters (EKOS Corporation, Bothell, Wash) were placed into the affected pulmonary arteries, and recombinant tissue plasminogen activator was infused through the catheters at 0.5 to 1.0 mg/h per catheter. RESULTS: Hypotension (systolic blood pressure <100 mm Hg) was present in 12 patients, with 100% resolution by treatment completion. Tachycardia (heart rate >100 beats/minute) was present in 26 patients and resolved in 92% by treatment completion; the average heart rate for all patients decreased from 109 to 77 beats/minute during the treatment period. Direct pulmonary artery pressure measurement showed average decrease of 21.5 mm Hg, representing a 40.2% reduction. Postprocedure echocardiography demonstrated complete resolution of cardiac dysfunction in 64%. Patients received a total dose of 30.5 mg (range, 14-66 mg) recombinant tissue plasminogen activator during an infusion time of 14.2 hours (range, 8-21 hours). There were no deaths through 90 days of follow-up and no major periprocedural bleeding events. CONCLUSIONS: This retrospective study demonstrates the safety and efficacy of current ultrasound-accelerated thrombolysis methods to treat acute pulmonary embolism.