Female Patients Have Fewer Limb Amputations Compared to Male Patients in the BEST-CLI Trial.

OBJECTIVE: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular versus best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. METHODS: In a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared to all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. RESULTS: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n=519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared to males: females were more likely to have rest pain alone (72% vs 60%, p <.0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%, p = .01). Females were less likely to have an adequate single segment greater saphenous vein (SSGSV) available (82% vs 89%, p = .01). Controlled for baseline clinical factors, at one year, females had significantly lower rates of major limb amputation compared to males (HR .70, p = .023), which drove better amputation- and MALE- free survival rates. All-cause death at one year was not statistically different between sexes (11.8% vs 11.2%, p=.286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared to endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared to females undergoing open surgical bypass (24.8% vs. 10.5%, p < .001). CONCLUSIONS: Despite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at one year compared to male patients. These findings suggest that in treating female CLTI patients considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

Contemporary management and outcomes of peripheral venous aneurysms: A multi-institutional study.

OBJECTIVE: Extremity venous aneurysms result in the risk of pulmonary embolism (PE) and chronic venous insufficiency. At present, owing to the rarity of these aneurysms, no consensus for their treatment has been established. The purpose of the present study was to review the presentation, natural history, and contemporary management of extremity venous aneurysms. METHODS: We performed a retrospective, multi-institutional review of all patients with extremity venous aneurysms treated from 2008 to 2018. A venous aneurysm was defined as saccular or fusiform with an aneurysm/vein ratio of >1.5. RESULTS: A total of 66 extremity aneurysms from 11 institutions were analyzed, 40 of which were in a popliteal location, 14 iliofemoral, and 12 in an upper extremity or a jugular location. The median follow-up was 27 months (range, 0-120 months). Of the 40 popliteal venous aneurysms, 8 (20%) had presented with deep vein thrombosis (DVT) or PE, 13 (33%) had presented with pain, and 19 had been discovered incidentally. The mean size of the popliteal venous aneurysms presenting with DVT or PE was larger than that of those presenting without thromboembolism (3.8 cm vs 2.5 cm; P = .003). Saccular aneurysm morphology in the lower extremity was associated with thromboembolism (30% vs 9%; P = .046) and fusiform aneurysm morphology with a thrombus burden >25% (45% vs 3%). Patients presenting with thromboembolism were more likely to have had a thrombus burden >25% in their lower extremity venous aneurysm compared with those who had presented without thromboembolism (70% vs 9%). Approximately half of all the patients underwent immediate intervention, and half were managed with observation or antithrombotic regimen. In the non-operative cohort, three patients subsequently developed a DVT. Eight patients in the medically managed cohort went on to require surgical intervention. Of the 12 upper extremity venous aneurysms, none had presented with DVT or PE, and only 2 (17%) had presented with pain. Of the 66 patients in the entire cohort, 41 underwent surgical intervention. The most common indication was the absolute aneurysm size. Nine patients had undergone surgery because of a DVT or PE, and 11 for pain or extremity swelling. The most common surgery was aneurysmorrhaphy in 21 patients (53%), followed by excision and ligation in 14 patients (35%). Five patients (12%) had undergone interposition bypass grafting. A postoperative hematoma requiring reintervention was the most common complication, occurring in three popliteal vein repairs and one iliofemoral vein repair. None of the patients, treated either surgically or medically, had reported post-thrombotic complications during the follow-up period. CONCLUSIONS: Large lower extremity venous aneurysms and saccular aneurysms with thrombus >25% of the lumen are more likely to present with thromboembolic complications. Surgical intervention for lower extremity venous aneurysms is indicated to reduce the risk of venous thromboembolism (VTE) and the need for continued anticoagulation. Popliteal aneurysms >2.5 cm and all iliofemoral aneurysms should be considered for repair. Upper extremity aneurysms do not have a significant risk of VTE and warrant treatment primarily for symptoms other than VTE.

Outcomes and practice patterns of medical management of blunt thoracic aortic injury from the Aortic Trauma Foundation global registry.

OBJECTIVE: Blunt thoracic aortic injury (BTAI) is the second leading cause of death from blunt trauma. In the present study, we aimed to determine the outcomes of medical management (MM) for BTAI. We hypothesized from the results of several previously reported studies, that patients with a minimal aortic injury (BTAI grades 1 and 2) could safely be treated with definitive MM alone. METHODS: The Aortic Trauma Foundation international prospective multicenter registry was used to examine the demographics, injury characteristics, management, and outcomes of patients with BTAI. We analyzed a subset of patients for whom MM was initiated as definitive therapy. RESULTS: From November 2016 to April 2020, 432 patients (median age, 41 years; 76% male; median injury severity score, 34) with BTAI (Society for Vascular Surgery grade 1, 23.6%; grade 2, 14.4%; grade 3, 51.2%; grade 4, 10.9%) were evaluated. Of the 432 patients, 245 (57%) had received MM in the initial period and 114 (26.4%) had received MM as the planned definitive therapy (grade 1, 59.6%; grade 2, 23.7%; grade 3, 15.8%; grade 4, 0.9%). The most common mechanism of BTAI was a motor vehicle collision (60.4%). Hypotension was present on arrival in 74 patients (17.2%). Continuous titratable infusion of antihypertensive medication was used for 49.1%, followed by intermittent bolus administration (29.8%), with beta-blockers (74.6%) the most common agent used. Treatments were targeted to a goal systolic blood pressure for 83.3%, most often to a target goal systolic blood pressure <120 mm Hg (66.3%). The MM goals based on blood pressure control were attained in 64.0% (73 of 114). Twelve patients (10.5%; grade 1, 1; grade 2, 0; grade 3, 10; grade 4, 1) had required subsequent intervention after MM. Eleven patients (9.6%) had undergone thoracic endovascular aortic repair and one (0.9%) had required open repair for a grade 4 injury. The overall in-hospital mortality for patients selected for definitive MM was 7.9%. No aortic-related deaths had occurred in the patients receiving definitive MM. CONCLUSIONS: Approximately one in four patients with BTAI will receive MM as definitive therapy. The variation in the pharmacologic therapies used is considerable. MM for patients with minimal aortic injury (BTAI grades 1 and 2) is safe and effective, with a low overall intervention rate and no aortic-related deaths. These findings support the use of definitive MM for grade 2 BTAI.

Surgical resection and graft replacement for primary inferior vena cava leiomyosarcoma: A multicenter experience.

OBJECTIVE: Primary leiomyosarcoma of the inferior vena cava (IVC) is best managed with surgical resection when technically feasible. However, consensus is lacking regarding the best choice of conduit and reconstruction technique. The aim of the present multicenter study was to perform a comprehensive assessment through the VLFDC (Vascular Low Frequency Disease Consortium) to determine the most effective method for caval reconstruction after resection of primary leiomyosarcoma of the IVC. METHODS: A multicenter, standardized database review of patients who had undergone surgical resection and reconstruction of the IVC for primary leiomyosarcoma from 2007 to 2017 was performed. The demographics, periprocedural details, and postoperative outcomes were analyzed. RESULTS: A total of 92 patients (60 women and 32 men), with a mean age of 60.1 years (range, 30-88 years) were treated. Metastatic disease was present in 22%. The tumor location was below the renal veins in 49 (53%), between the renal and hepatic veins in 52 (57%), and above the hepatic veins in 13 patients (14%). The conduits used for reconstruction included ringed polytetrafluoroethylene (PTFE; n = 80), nonringed PTFE (n = 1), Dacron (n = 1), autogenous vein (n = 1), bovine pericardium (n = 4), and cryopreserved tissue (n = 5). Complete R0 resection was accomplished in 73 patients (79%). In-hospital mortality was 2%, with a median length of stay of 8 days. The primary patency of PTFE reconstructed IVCs was 97% and 92% at 1 and 5 years, respectively, compared with 73% at 1 and 5 years for the non-PTFE reconstructed IVCs. The overall 1-, 3-, and 5-year survival for the entire cohort were 94%, 86%, and 65%, respectively CONCLUSIONS: The findings from our multi-institutional study have demonstrated that complete en bloc resection of IVC leiomyosarcoma with vascular surgical reconstruction in selected patients results in low perioperative mortality and is associated with excellent long-term patency. A ringed PTFE graft was the most commonly used conduit for caval reconstruction, yielding excellent long-term primary patency.

Five-year outcomes of endovascular repair of complicated acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair is the standard of care for acute complicated type B aortic dissections, but long-term single-device outcomes are limited. METHODS: Fifty patients were treated with the Valiant Captivia thoracic stent graft (Medtronic Inc, Santa Rosa, Calif) for acute complicated type B aortic dissections in this prospective, nonrandomized Dissection Trial. All-cause mortality, secondary procedures, and serious adverse events were assessed, and a core lab evaluated images for aortic remodeling. RESULTS: Compliance for both clinical and imaging follow-up was 78% (18 out of 23) for the available patients at 5 years. Notable baseline characteristics were 86% of patients (43 out of 50) had malperfusion, 20% (10 out of 50) had ruptures, and 94% (46 out of 49) had DeBakey class IIIB dissections. The 5-year freedom from dissection-related mortality, secondary procedures related to the dissection, and endoleaks was 83%, 86%, and 85%, respectively. After 5 years, 89% of patients (16 out of 18) had a completely thrombosed false lumen in the stented segment of the aorta and the true lumen diameter over the length of stent graft was stable or increased for 94% of patients (16 out of 17) while the false lumen diameter was stable or decreased in 77% (13 out of 17) after 5 years. CONCLUSIONS: In the Dissection Trial, patients experienced positive and sustained measures of aortic remodeling. Survival outcomes, need for secondary procedures, and adverse event rates were consistent with previous thoracic endovascular aortic repair studies. Although limitations exist with the follow-up compliance, the Valiant Captivia thoracic stent graft system was effective in the long-term management of acute complicated type B aortic dissections in this patient population with a challenging condition.

Aortic endograft sizing and endoleak, reintervention, and mortality following endovascular aneurysm repair.

OBJECTIVE: Endograft sizing for endovascular abdominal aortic aneurysm repair (EVAR) is not consistent despite published instructions for use (IFU). We sought to identify factors associated with over/undersizing, determine sex influence on sizing, and examine sizing effects on endoleak, reintervention, and mortality by analyzing data obtained from the W.L. Gore & Associates Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: All patients enrolled in GREAT undergoing EVAR were included for analysis. Proximal/distal aortic landing zones were compared with device implanted to assess sizing as related to IFU. χ2/Fisher exact tests were used to evaluate associations between IFU sizing and demographics. Logistic regression modeling was used to identify predictors of outside IFU sizing. Cox proportional hazards regression analyzed the relationship between sizing and endoleak, device-related reinterventions, and all-cause/aortic mortality. RESULTS: There were 3607 EVAR subjects enrolled in GREAT as of March 2020. Of them, 1896 (53%) were within IFU for sizing, 791 (22%) were oversized, 540 (15%) were undersized, and 380 (10%) had both over- and undersized components. Factors predictive of use outside of IFU included female sex (P = .001), non-white race (P = .0003), decreased proximal neck length (P < .061), or larger iliac diameters (P < .0001). Women were more likely than men to have proximal neck undersizing and iliac limb oversizing, and men were more likely to have iliac limb undersizing. On multivariate analysis, undersizing of the proximal graft was associated with endoleak (hazard ratio [HR], 1.8) and aortic (HR, 60.5) and all-cause (HR, 18.0) mortality. Undersizing of iliac limbs was associated with endoleak (HR, 1.5) and device-related reintervention (HR, 1.4). Iliac limb outside IFU sizing was associated with aortic (HR, 2.6) and all-cause (HR, 1.3) mortality. Proximal and distal oversizing was not associated with adverse outcomes. Female sex was associated with mortality on univariate but not multivariate analysis. CONCLUSIONS: Women undergoing EVAR with GORE EXCLUDER abdominal aortic aneurysm Endoprosthesis (W.L. Gore & Associates Inc, Flagstaff, Ariz) are more likely to have proximal stent-graft undersizing and iliac limb oversizing, whereas men are more likely to have undersized iliac limbs. Proximal aortic graft undersizing is associated with endoleak and all-cause/aortic mortality, whereas undersizing of iliac limbs is associated with endoleak and device-related reintervention. Oversizing was not associated with adverse outcomes.

In-hospital outcomes and long-term survival of women of childbearing age with aortic dissection.

OBJECTIVE: In the present study, we defined the outcomes and effects of pregnancy in a cohort of women of childbearing age with acute aortic dissection (AAD). METHODS: We reviewed our database of AAD to identify all eligible female patients. Women aged <45 years were included. Data on pregnancy timing with respect to the occurrence of dissection, the demographic data, dissection extent, dissection treatment, dissection-related outcomes, overall maternal and fetal mortality, and genetic testing results were analyzed. RESULTS: A total of 62 women aged <45 years had presented to us with AAD from 1999 to 2017. Of the 62 women, 37 (60%) had had a history of pregnancy at AAD. Of these 37 patients, 10 (27%) had had a peripartum aortic dissection, defined as dissection during pregnancy or within 12 months postpartum. Of the 10 AADs, 5 were type A and 5 were type B. Three patients had presented with AAD during pregnancy (one in the second and two in the third trimester). Five patients (50%) had developed AAD in the immediate postpartum period (within 3 months) and two (20%) in the late postpartum period. For the immediate postpartum AADs (<3 months), four of the five patients delivered via cesarean section. Of these 10 peripartum AADs, 3 (30%) had occurred in patients with known Marfan syndrome. In-hospital mortality for those with peripartum AAD was 10% (1 of 10). Fetal mortality was 20% (2 of 10). CONCLUSIONS: The frequency of aortic dissection in women of childbearing age at our institution was low. However, pregnancy might increase the risk of those young women genetically predisposed to dissection events. From these data, this risk appears to be greatest in the immediate postpartum period, even for those who undergo cesarean section. Close clinical and radiographic surveillance is required for all women with suspected aortopathy, especially in the third trimester and early postpartum period.

Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial.

Importance: Liposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations. Objective: To compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions. Design, Setting, and Participants: This randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018. Intervention: Patients were randomized to standard bupivacaine or liposomal bupivacaine. Main Outcomes and Measures: Pain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption. Results: A total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (ß = -0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use. Conclusions and Relevance: In this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days. Trial Registration: ClinicalTrials.gov Identifier: NCT02111746.

Resection and replacement of thoracic aortic graft infections.

OBJECTIVES: Thoracic aortic graft infection (TAGI) presents a formidable challenge with high mortality. We evaluated our 22-year experience managing TAGI with extensive debridement, graft replacement, vascularized tissue coverage, and aggressive antibiotics. METHODS: We reviewed all consecutive patients with TAGI from 1991 to 2013. We also compared infected cases versus noninfected reoperative controls using a case-control design. Standard statistical methods were used for descriptive analysis, and Kaplan-Meier for survival analysis. RESULTS: We treated 32 TAGI patients, involving 19 ascending/arch (A/A) and 13 descending/thoracoabdominal (D/TAA) grafts, including 4 endografts. In total, 19 (59.4%) presented with pseudoaneurysm and 11 (34.4%) with aortic fistula. Vascularized tissue (omentum or muscle) coverage was possible in 22 (71.0%) patients. Thirty-day mortality occurred in 3 (9.4%) patients, with no 30-day mortality among those receiving vascularized graft coverage (P = .018). During follow-up, reinfection occurred in 8 patients (25% [4 A/A and 4 D/TAA]). Five-year overall (A/A 45.4% vs D/TAA 28.9%, P = .434) and reinfection-free (A/A 19.2%, D/TAA 27%, P = .409) survival was similar between groups. Long-term mortality was greater after endograft infection (100% vs 25% at 2.5 months, P = .0007) or aortobronchial fistulization (100% vs 37.9% at 6 months, P = .026). Time to reintervention was shorter in infected versus non-infected reoperative cases (31 vs 83 months, P < .0001), but there were no significant differences in long-term mortality after reoperation. CONCLUSIONS: TAGI continues to represent a highly morbid surgical challenge. Prompt antimicrobial coverage, debridement, graft replacement, and vascularized graft coverage, yielded best long-term results. Endograft infection and aortobronchial fistula had very poor prognoses.

Do patients with minimal blunt thoracic aortic injury require thoracic endovascular repair?

INTRODUCTION: The optimal management of minimal blunt thoracic aortic injuries (BTAIs) remains controversial, with experienced centers using therapy ranging from medical management (MM) to thoracic endovascular aortic repair (TEVAR). METHODS: The Aortic Trauma Foundation registry was used to examine demographics, injury characteristics, management, and outcomes of patients with BTAI. RESULTS: Two hundred ninety-six patients from 28 international centers were analyzed (mean age, 44.5 years [SD, 18 years]; 76% [225/296] male; mean Injury Severity Score, 34 [SD, 14]). Blunt thoracic aortic injury was classified as Grade I, 22.6% (67/296); Grade II, 17.6% (52/296); Grade III, 47.3% (140/296); and Grade IV, 12.5% (37/296). Overall aortic-related mortality (ARM) was 4.7% (14/296). Among all deaths, 33% (14/42) were ARM. Open repair was required for only 2%, with most undergoing TEVAR (58.4%) or MM (28.0%). Thoracic endovascular repair complications occurred in 3.4% (6/173), most commonly Type 1 endoleak (2.3%; 4/173). Among patients with minimal aortic injury (Grades I and II), 59.7% (71/119) received MM, while 40.3% (48/119) underwent TEVAR. Two patients initially managed with MM required subsequent TEVAR for injury progression during initial hospital stay. No significant difference in ARM between MM and TEVAR was noted for Grades I and II injuries. CONCLUSION: A third of the trauma victims with BTAI succumb to ARM. Thoracic endovascular repair has replaced open repair but remains equivalent in outcomes to MM for minimal injuries. These data support MM of patients with minimal aortic injury. LEVEL OF EVIDENCE: Therapeutic study, level IV.

Fewer Cardiopulmonary Complications and Shorter Length of Stay in Anterolateral Thoracolumbar Spine Exposures Using a Small-Incision Specialized Retractor System.

Objectives: One of the challenges of spine surgery is the need for adequate exposure of the anterolateral spinal column. Improved retractor systems with integrated lighting minimize the need for large thoracotomy, flank, or abdominal incisions. In 2013, we began using the NuVasive MaXcess® system via a minimal-access lateral incision for thoracic and thoracolumbar spine exposures. These small-access approaches may not offer adequate exposure when bleeding and other complications arise. We sought to determine the feasibility and outcomes of a minimal-access retractor during anterolateral spine exposures. Methods: An institutional-review-board-approved retrospective chart review was performed of all patients who underwent anterolateral thoracic and lumbosacral spine exposure at an academic hospital between December 1999 and April 2017. Cervical and posterior spine exposures were not included. Information regarding patient demographics, comorbid conditions, operative techniques, exposure, estimated blood loss, length of stay, and intraoperative and postoperative complications was collected. Data for standard exposure vs. minimally invasive exposures were compared. Results: Between December 1999 and April 2017, 223 anterolateral spinal exposures were performed at our institution. Of those, 122 (54.7%) patients had true lateral exposures, with 22 (18%) using the minimally invasive retractor. The mean age of our patient population was 57 years (19-89), with 65 (53%) men and a mean body mass index of 29.0 (17.4-58.6). In the standard exposure group, complications occurred in 22 (22%) patients, whereas only two (9%) complications occurred in the minimal-access group. There were no significant differences in overall intraoperative and postoperative complications, except for cardiopulmonary complications, which were reduced in the minimally invasive group (p < 0.019). Patients with minimally invasive exposure had a significantly shorter length of stay than those with standard exposure (7 vs. 13 days, p = 0.001). Conclusions: Minimal-access techniques using advanced retractor systems are both feasible and safe compared to standard techniques allowing for similar lateral spine exposure, but with smaller incisions, fewer cardiopulmonary complications, and shorter lengths of stay.

Characteristics of Trauma Mortality in Patients with Aortic Injury in Harris County, Texas.

BACKGROUND: The National Academies of Science have issued a call for zero preventable trauma deaths. The mortality characteristics in all patients with aortic injury are not well described. METHODS: All prehospital and hospital medical examiner records for deaths occurring in Harris County, Texas in 2014 were retrospectively reviewed, and patients with traumatic aortic injury were selected. The level of aortic injury was categorized by zone (0 through 9) and further grouped by aortic region (arch, zones 0 to 2; descending thoracic, zones 3 to 5; visceral abdominal, zones 6 to 8; infrarenal, zone 9). Multiple investigators used standardized criteria to categorize deaths as preventable, potentially preventable, or non-preventable. RESULTS: Of 1848 trauma deaths, 192 (10%) had aortic injury. There were 59 (31%) aortic arch, 144 (75%) descending thoracic, 19 (10%) visceral abdominal, and 20 (10%) infrarenal aortic injuries. There were 178 (93%) non-preventable deaths and 14 (7%) potentially preventable deaths, and none were preventable. Non-preventable deaths were associated with blunt trauma (69%) and the arch or thoracic aorta (93%), whereas potentially preventable deaths were associated with penetrating trauma (93%) and the visceral abdominal or infrarenal aorta (79%) (all p < 0.05). Half of potentially preventable deaths (n = 7) occurred at the scene, and half occurred at a trauma center. CONCLUSION: Potentially preventable deaths after aortic injury were associated with penetrating mechanism and injury to the visceral abdominal and/or infrarenal aorta. Optimal prehospital and ED treatment include temporizing hemorrhage control, hemostatic resuscitation, and faster transport to definitive treatment.

Heparin-bonded versus standard polytetrafluoroethylene arteriovenous grafts: A Bayesian perspective on a randomized controlled trial for comparative effectiveness.

BACKGROUND: Heparin-bonded polytetrafluoroethylene grafts were marketed to improve hemodialysis access outcomes but are twice the cost of standard polytetrafluoroethylene. We launched a randomized trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for hemodialysis access to compare patency. Since the trial began, additional studies were published with heterogeneous findings. We performed an interim analysis by Bayesian methods using prior probability from meta-analysis of existing literature. METHODS: NCT01601873 is a randomized, blinded trial of heparin-bonded polytetrafluoroethylene versus standard polytetrafluoroethylene for dialysis access at 5 sites. Planned sample size was 200 with 1-year primary patency as the primary endpoint. At interim analysis (50% of sample size at 1 year), we also performed a meta-analysis for 1-year primary patency with a random effects model to compute summary rate ratio and standard-error estimates. Meta-analysis estimates formed a prior probability for a Bayesian Cox regression model, and trial data were reanalyzed to develop posterior probability of heparin-bonded polytetrafluoroethylene effectiveness at our hypothesized effect size. Futility analysis was conducted using posterior probability estimates. RESULTS: One hundred and five patients were enrolled at the time of interim analysis. One-year primary patency was 34.9% in the heparin-bonded-polytetrafluoroethylene group vs 32.7% in the standard-polytetrafluoroethylene group (P = .884). Summary rate ratio from the meta-analysis (1,209 patients) was 0.87 favoring heparin-bonded polytetrafluoroethylene (P = .33). Posterior hazard ratio from Cox regression was 0.90 (credible interval 0.70-1.13) favoring heparin-bonded polytetrafluoroethylene, which was not significant. Bayesian posterior probability of the a priori hypothesized 20% better patency with heparin-bonded polytetrafluoroethylene was 24%. Sample size to detect superiority with the small observed effect size would require about 3,800 subjects. CONCLUSION: Current evidence does not demonstrate sufficiently large benefit of heparin-bonded polytetrafluoroethylene over standard polytetrafluoroethylene for dialysis access to justify higher cost. Given similar 1-year patency rates, a conclusive finding of superiority was judged to be infeasible, and the trial was stopped for futility.

Managing central venous access during a health care crisis.

OBJECTIVE: During the COVID-19 pandemic, central venous access line teams were implemented at many hospitals throughout the world to provide access for critically ill patients. The objective of this study was to describe the structure, practice patterns, and outcomes of these vascular access teams during the COVID-19 pandemic. METHODS: We conducted a cross-sectional, self-reported study of central venous access line teams in hospitals afflicted with the COVID-19 pandemic. To participate in the study, hospitals were required to meet one of the following criteria: development of a formal plan for a central venous access line team during the pandemic; implementation of a central venous access line team during the pandemic; placement of central venous access by a designated practice group during the pandemic as part of routine clinical practice; or management of an iatrogenic complication related to central venous access in a patient with COVID-19. RESULTS: Participants from 60 hospitals in 13 countries contributed data to the study. Central venous line teams were most commonly composed of vascular surgery and general surgery attending physicians and trainees. Twenty sites had 2657 lines placed by their central venous access line team or designated practice group. During that time, there were 11 (0.4%) iatrogenic complications associated with central venous access procedures performed by the line team or group at those 20 sites. Triple lumen catheters, Cordis (Santa Clara, Calif) catheters, and nontunneled hemodialysis catheters were the most common types of central venous lines placed by the teams. Eight (14%) sites reported experience in placing central venous lines in prone, ventilated patients with COVID-19. A dedicated line cart was used by 35 (59%) of the hospitals. Less than 50% (24 [41%]) of the participating sites reported managing thrombosed central lines in COVID-19 patients. Twenty-three of the sites managed 48 iatrogenic complications in patients with COVID-19 (including complications caused by providers outside of the line team or designated practice group). CONCLUSIONS: Implementation of a dedicated central venous access line team during a pandemic or other health care crisis is a way by which physicians trained in central venous access can contribute their expertise to a stressed health care system. A line team composed of physicians with vascular skill sets provides relief to resource-constrained intensive care unit, ward, and emergency medicine teams with a low rate of iatrogenic complications relative to historical reports. We recommend that a plan for central venous access line team implementation be in place for future health care crises.

Differences in quality of life outcomes after paraclavicular decompression for thoracic outlet syndrome.

BACKGROUND: Thoracic outlet syndrome (TOS) results from compression of the neurovascular structures in the thoracic outlet. Decompression provides relief of TOS symptoms. However, little is known about long-term function and quality of life (QoL) from a patient's perspective. The purpose of this study was to evaluate surgical and QoL outcomes after surgical decompression of the thoracic outlet using a paraclavicular approach. METHODS: A prospectively maintained database was used to conduct a retrospective review of patients who underwent thoracic outlet decompression between August 2004 and August 2018. We excluded patients without complete follow-up data. Functional outcomes were assessed by the Derkash classification (poor, fair, good, excellent) using contingency table methods, and QoL was assessed by the 12-Item Short Form Health Survey (SF-12) using general linear models. SF-12 was scored by published criteria, and scale-specific and aggregate mental and physical health-related QoL scores were computed. Aggregate QoL scores range from 0 (terrible) to 100 (perfect). Secondary outcomes included mortality, complications, and duration of hospital stay. RESULTS: We performed 105 operations for TOS, and 100 patients with complete follow-up data were included in the study. Five patients were lost to follow-up. Median age was 35 (interquartile range, 24-47) years, and 58 (58%) were female. The median duration of hospital stay was 4 (interquartile range, 3-5.5) days. Of these patients, 46 had venous etiology, 8 arterial, 42 neurogenic, and 4 mixed vascular and neurogenic. Good or excellent Derkash results were reported in 77 (77%) patients, 46 of 54 (85%) of those with vascular TOS vs 31 of 46 (67%) of those with neurogenic etiology (P < .036). SF-12 score was obtained in 93 of 100 (93%) with a median duration from surgery of 6.1 (3.3-9.3) years. Patients with neurogenic TOS (NTOS) reported significantly lower aggregate mental health QoL than patients with vascular-only TOS (57 vs 59; P < .016). This effect persisted across the entire duration of follow-up and was unaffected by time from surgery (regression P for time = .509). In contrast, aggregate physical function QoL was unaffected by neurogenic etiology (P = .303), and all patients improved linearly with time (0.5 scale unit/y; P < .009). Three patients with incomplete relief of symptoms after paraclavicular decompression for NTOS underwent pectoralis minor decompression. There were no deaths or injuries to the long thoracic nerve. Complications included pleural effusion or hemothorax requiring evacuation (n = 6), neurapraxia (n = 6), and lymph leak (n = 2) treated with tube thoracostomy. CONCLUSIONS: NTOS is associated with significantly worse functional outcome assessed by the Derkash classification. NTOS also demonstrated worse composite mental health QoL, which did not improve over time. In contrast, composite physical health QoL improved linearly with time from surgery regardless of etiology of TOS.

Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections.

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.

Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections.

This Society for Vascular Surgery/Society of Thoracic Surgeons (SVS/STS) document illustrates and defines the overall nomenclature associated with type B aortic dissection. The contents describe a new classification system for practical use and reporting that includes the aortic arch. Chronicity of aortic dissection is also defined along with nomenclature in patients with prior aortic repair and other aortic pathologic processes, such as intramural hematoma and penetrating atherosclerotic ulcer. Complicated vs uncomplicated dissections are clearly defined with a new high-risk grouping that will undoubtedly grow in reporting and controversy. Follow-up criteria are also discussed with nomenclature for false lumen status in addition to measurement criteria and definitions of aortic remodeling. Overall, the document provides a facile framework of language that will allow more granular discussions and reporting of aortic dissection in the future.