Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

Purpose: This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. Patients and Methods: QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. Results: At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. Conclusion: The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Mobility Rates After Lower-Limb Amputation for Patients Treated with Physician-Led Collaborative Care Model.

BACKGROUND: Clinical outcomes after major lower-limb amputation have been historically poor. The current care provided to most amputees is often disorganized and without physician supervision. The primary purpose of this study is to examine rates of postamputation mobility achieved with a prosthesis by patients with chronic limb-threatening ischemia and/or diabetes who required major lower-limb amputation and were treated under an established physician-led collaborative care pathway. The secondary purpose is to describe the structure and utilization of the care pathway by multiple independent vascular surgery practices in the United States to enable future exploration of its impact on key clinical outcomes within this patient population. METHODS: Clinical records of 2,475 patients from 6 vascular practices that adopted this collaborative care pathway between 2017 and 2020 were retrospectively reviewed. Only records with sufficient documented histories of amputation surgeries, prosthetic services, and mobility status were included. RESULTS: Of 2,475 patient records reviewed, 1,787 patients (2,157 major amputations) were eligible for analysis. Sixty-two-point 2 percent (n = 1,111) of patients achieved mobility with the collaborative care pathway. Mobility rate varied by amputation level in the study. Prosthetic mobility was achieved in 73.5% of transtibial amputations, 40.4% of transfemoral amputations, and 35.7% of through-knee amputations, regardless of patient laterality, which is superior or equivalent to the best published rates of mobility. CONCLUSIONS: The study describes the structure and utilization of a physician-led collaborative care pathway for treating patients who require lower-limb amputation that meets 5 of the 7 recommendations from the 2019 Global Vascular Guidelines on the Management of Chronic Limb Threatening Ischemia. Internal data analysis results suggest that patients treated via this care pathway can potentially achieve improved mobility rates with a prosthesis following amputation. This collaborative care pathway should be further evaluated for its ability to directly improve mobility and other clinically relevant amputation outcomes.

Impact of Patient and Procedural Factors on Outcomes Following Mesenteric Bypass.

BACKGROUND: Mesenteric bypass (MB) for patients with acute (AMI) and chronic mesenteric ischemia (CMI) is associated with cardiovascular (CV) and pulmonary morbidity. METHODS: Patients with AMI and CMI from 2008 to 2019 were identified to determine independent predictors of CV (cardiac arrest, MI, DVT, and stroke) and pulmonary (pneumonia and ventilator time>48 h) morbidities in patients undergoing MB. RESULTS: 377 patients were identified. Patients with AMI had higher rates of preoperative SIRS/sepsis (28 vs 12%, P < .0001), were more likely to be ASA class 4/5 (55 vs 42%, P = .005), were more likely to require bowel resection (19 vs 3%, P < .0001), and were more likely to have vein utilized as their bypass conduit (30 vs 14%, P < .0001). There were no differences in use of aortic or iliac inflow (P = .707) nor in return to the OR (24 vs 19%, P = .282). Both postoperative sepsis (12 vs 2.6%, P = .003) and mortality (31.4% vs 9.8%, P < .0001) were significantly increased in patients with AMI. After adjusting for both patient and procedural factors, multivariable logistic regression (MLR) identified international normalized ratio (INR) (OR 3.16; 95% CI 1.56-6.40, P = .001) and chronic heart failure (CHF) (OR 5.88; 95% CI 1.15-29.97, P = .033) to be independent predictors of pulmonary morbidity, while preoperative sepsis (OR 1.96; 95% CI 1.45-2.66, P < .0001) alone was predictive of CV morbidity in all patients undergoing MB. DISCUSSION: Mesenteric bypass for mesenteric ischemia leads to high rates of morbidity and mortality, whether done in an acute or chronic setting. Preoperative sepsis, independent of AMI or CMI, predicts CV morbidity, regardless of bypass configuration or conduit, while elevated INR or underlying CHF carries a higher risk of pulmonary morbidity.

Risk Factors for Acute Renal Failure After Endovascular Aneurysm Repair.

BACKGROUND: Acute kidney injury (AKI) after endovascular aortic aneurysm repair (EVAR) is uncommon though carries significant morbidity. Procedural risk factors are not well established for acute renal failure (ARF) that requires initiation of dialysis. The goal of this study was to examine the impact of ARF on patients undergoing EVAR and identify risk factors for ARF using a large, national dataset. METHODS: Patients undergoing EVAR were identified from the National Surgical Quality Improvement Program (NSQIP) database over 9 years, ending in 2019. Demographics, indication for repair, comorbidities, procedural details, complications, hospital and ICU LOS, and mortality were recorded. Patients were stratified by presence of ARF and compared. Patients were further stratified by indication for EVAR and presence of ARF. Multivariable logistic regression (MLR) analysis was performed to determine the independent predictors of ARF. RESULTS: 18 347 patients were identified. Of these 234 (1.3%) developed ARF requiring dialysis. Mortality (40 vs 1.8%, P < .0001), ICU LOS (5 vs 0 days, P < .0001), and hospital LOS (11 vs 2 days, P < .0001) were all significantly increased in patients with ARF. Multivariable logistic regression identified increasing diameter, creatinine, operative time, preoperative transfusions, ASA class, emergent repair, female gender, and juxtarenal/suprarenal proximal landing zone as predictors of ARF. CONCLUSIONS: ARF after EVAR causes significant morbidity, prolongs hospitalizations, and increases mortality rates. Those patients at risk of ARF after EVAR should be closely monitored to reduce both morbidity and mortality.

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry.

OBJECTIVE: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort. METHODS: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively. RESULTS: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements. CONCLUSIONS: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.

Initiative to reduce inappropriate venous thromboembolism prophylaxis in an 11-hospital safety net system: An electronic health records-based approach.

BACKGROUND: While pharmacologic prophylaxis has benefits for venous thromboembolism (VTE) prevention in high-risk patients, unnecessary use carries potential harm, including bleeding, heparin-induced thrombocytopenia, and patient discomfort, and should be avoided in low-risk patients. While many quality improvement initiatives aim to reduce underuse, successful models on reducing overuse are sparse in the literature. OBJECTIVE: We aimed to create a quality improvement initiative to reduce overuse of pharmacologic VTE prophylaxis. DESIGNS, SETTINGS AND PARTICIPANTS: A quality improvement initiative was implemented across 11 safety net hospitals in New York City. INTERVENTION: The first electronic health record (EHR) intervention consisted of a VTE order panel that facilitated risk assessment and recommended VTE prophylaxis for high-risk patients only. The second EHR intervention used a best practice advisory that alerted clinicians when prophylaxis was ordered for a patient previously deemed "low risk." Prescribing rates were compared through a three-segment interrupted time series linear regression design. RESULTS: Compared to the preintervention period, the first intervention did not change the rate of total pharmacologic prophylaxis immediately after implementation (1.7% relative change, p = .38) or over time (slope difference of 0.20 orders per 1000 patient days, p = .08). Compared to the first intervention period, the second intervention led to an immediate 4.5% reduction in total pharmacologic prophylaxis (p = .04) but increased thereafter (slope difference of 0.24, p = .03) such that weekly rates at the end of the study were similar to rates prior to the second intervention.

Keeping the Lights On: The Impact of the COVID-19 Pandemic on Elective Total Joint Arthroplasty Utilization in the United States.

Background: It was estimated that up to 30,000 primary total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures would be cancelled each week during the moratorium on elective surgeries in the United States. The purpose of this study was to analyze the impact of the COVID-19 pandemic on elective total joint arthroplasty utilization in the United States. Methods: A retrospective study was conducted using the PearlDiver database. Patients who underwent primary elective THAs and TKAs were identified and filtered by state and month from January through September of both 2019 and 2020. The volume of these procedures immediately following the moratorium on elective surgeries was compared to that of the same months the previous year. Results: For THA, overall, there was a 27.39% reduction in volume from 2019 to 2020 in March and an 88.94% reduction in April. For TKA, overall, there was a 31.28% reduction in volume in March and a 96.61% reduction in April. When the states were separated into 2 cohorts by the 2020 presidential election vote, there was a significantly larger decrease in THA and TKA volume observed in the 25 states and Washington DC that voted democrat than that in the 25 states that voted republican in both March (P < .05) and April (P < .05). Both THA (118.29%) and TKA (101.02%) volume returned to prepandemic levels by June. Conclusions: Overall, this study demonstrated that elective total joint arthroplasty utilization did reduce as anticipated following the CMS moratorium on elective surgeries but quickly returned to prepandemic levels by June. Level of Evidence: Level III.

The Impact of Epilepsy on Complication Rates After Total Joint Arthroplasty: A Propensity Score-Matched Cohort Study.

BACKGROUND: It is unclear how epilepsy may affect total joint arthroplasty outcomes. The purpose of this study is to analyze the impact of epilepsy on prosthesis-related complications following primary total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: A retrospective cohort study was conducted using a national database. Patients who have epilepsy underwent a primary THA (n = 6,981) and TKA (n = 4,987) and were matched 1:4 (THA, n = 27,924; TKA, n = 19,948). Rates of low-energy falls and prosthesis-related complications within 2 years postoperatively were compared for patients who did and did not have epilepsy with multivariable logistic regression. RESULTS: After primary TKA, patients who have epilepsy exhibited significantly higher rates of aseptic revision (4.3% versus 3.5%, odds ratio [OR] 1.21, P = .017) and revision for prosthetic joint infection (1.8% versus 1.3%, OR 1.29, P = .041). THA patients who have epilepsy exhibited significantly higher rates of prosthetic dislocation (3.2% versus 1.9%, OR 1.54, P < .001), periprosthetic fracture (2.2% versus 0.8%, OR 2.39, P < .001), and aseptic loosening (1.7% versus 1.1%, OR 1.40, P = .002). Rates of low-energy falls within 2 years after TKA (14.1% versus 6.4%, OR 2.19, P < .001) and THA (33.6% versus 7.5%, OR 5.95, P < .001) were also significantly higher for patients who have epilepsy. CONCLUSION: Epilepsy was associated with significantly higher rates of falls (P < .001) and prosthesis-related complications after primary THA (P < .05) and TKA (P < .05). Precautions should be implemented in this population during intraoperative and perioperative decision-making to reduce complication risk. LEVEL OF EVIDENCE: Level III.

Does pre-arthroplasty antiviral treatment for hepatitis C reduce complication rates after total shoulder arthroplasty? A matched cohort study.

Background: Hepatitis C virus (HCV) is associated with increased complications of risk after arthroplasty. The purpose of this study was to examine the impact of HCV and a pre-arthroplasty antiviral treatment on complications following total shoulder arthroplasty (TSA). Methods: A retrospective matched cohort study was conducted using an administrative claims database. Patients who underwent TSA were identified with Current Procedural Terminology -23472 and International Classification of Diseases procedural codes. A total of 1244 HCV patients were matched 1:3 with 3732 noninfected controls across age, sex, diabetes mellitus, tobacco use, and obesity. The HCV patients with treatment before TSA were identified by claims containing antiviral drug codes. Multivariable logistic regression was used to compare rates of 90-day medical complications and prosthesis-related complications within 2 years postoperatively for (1) HCV patients vs. controls, (2) antiviral-treated HCV patients vs. controls, and (3) antiviral-treated HCV patients vs. untreated HCV patients. Results: Patients with HCV exhibited significantly higher rates of blood transfusion (OR 2.12), acute kidney injuries (OR 1.86), inpatient readmission (OR 2.06), revision TSA (OR 1.48), dislocation (OR 1.92), mechanical complications (OR 1.39), and prosthetic joint infection (OR 1.53) compared to controls. Antiviral-treated HCV patients exhibited a significantly lower rate of myocardial infarction (OR 0.27) and comparable rates of all other complications relative to controls (all P > .05). Compared to untreated HCV patients, antiviral-treated HCV patients exhibited significantly lower rates of 90-day medical complications (OR 0.57) and prosthetic joint infection (OR 0.36). Conclusions: HCV is associated with significantly increased complication rates after TSA. Antiviral treatment before TSA may reduce the risk of postoperative complications.

Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA2DS2-VASc Score: Results of the Randomized ATLAS Trial.

OBJECTIVE: Patients with elevated CHA2DS2-VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF). METHODS: ATLAS (NCT02701062) was a prospective, multicenter, feasibility trial. Patients age ≥18 years, undergoing structural heart procedure, with no preoperative AF, CHA2DS2-VASc ≥2, and HAS-BLED ≥2 were randomized 2:1 to LAAE or no LAAE. Patients who developed POAF and/or received LAAE were followed for 1 year. LAAE was evaluated with intraoperative transesophageal echocardiography. RESULTS: A total of 562 patients were randomized to LAAE (n = 376) or no LAAE (n = 186). Mean CHA2DS2-VASc (3.4 vs 3.4) and HAS-BLED (2.8 vs 2.9) scores were similar for LAAE and no LAAE groups. LAAE success (no flow nor residual stump >10 mm) was 99%. One LAAE-related serious adverse event (0.27%) occurred and was resolved without sequelae. There were 44.3% of patients who developed POAF. Through 1 year, 3.4% of LAAE patients and 5.6% of no LAAE patients had TE. OAC was used by 32.5% of POAF patients. Bleeding was higher with OAC than without (16.1% vs 5.4%, P = 0.008). CONCLUSIONS: ATLAS demonstrated a high rate of successful LAAE with low LAAE-related serious adverse events in cardiac surgery patients. Study results should be considered in future trial design to further evaluate prophylactic LAAE for stroke prevention in cardiac surgery patients with elevated stroke risk.

Analysis of Factors Potentially Influencing Diagnostic Yield Among Computed Tomography-Guided Biopsies for Bone Lesions.

OBJECTIVE: This study aimed to investigate patient-specific, lesion-related, and technical factors that potentially influence diagnostic yield of computed tomography (CT)-guided biopsies of bone lesions. METHODS: Computed tomography-guided bone lesion biopsies performed over a 2-year period were retrospectively reviewed, including image review and electronic medical records for pathology reports and clinical follow-up. Lesions were tabulated by prebiopsy CT and magnetic resonance imaging features. Patients with nondiagnostic biopsies were assessed for presumptive clinical diagnosis and management. RESULTS: Nondiagnostic pathology results were obtained in 31 of 156 cases (19.87%), among which diagnoses were confirmed by other tissue sampling in 9; clinical follow-up of up to 2 years yielded no diagnosis in 10 and presumptive diagnoses in 12. The nondiagnostic biopsy rate of long bone lesions was higher than that of other bone lesions (odds ratio, 3.46; 95% confidence interval, 1.32-9.09). There were no significant differences in patient American Society of Anesthesiologists class, mean body mass index, sedation method, number of cores, or needle gauge between diagnostic and nondiagnostic biopsy cohorts. Diagnostic yield was not significantly different between occult, lytic, or sclerotic lesions. There was no difference in diagnostic yield regarding presence of cortical break, gadolinium enhancement, or lesion depth. Magnetic resonance imaging was obtained before biopsy in significantly more nondiagnostic cases compared with diagnostic cases ( P = 0.027). CONCLUSIONS: Computed tomography-guided biopsies had a nondiagnostic rate of 19.87%, and lesions in the long bones of the extremities were disproportionately common among this group. There was no significant association between biopsy results and several patient-specific, lesion-related, and technical factors.

Examining the Relationship Between Mild Traumatic Brain Injuries and Development of Mental Illness Disorders in a Mid-Term Follow-up Period.

OBJECTIVE: The sequalae of mild concussions continue to emerge with increased awareness in sports-related injuries. This study aimed to quantify the number of patients who are affected by a mental illness within 3 yrs of a concussion and identify whether demographic differences exist that may influence a mental illness diagnosis. DESIGN: Using a nationwide database, data were queried for a diagnosis of concussion, capturing patients aged 18-45 yrs with no previous mental illness, and then identified if these patients were diagnosed with a mental illness within 3 yrs of their concussion. The mental illnesses specifically chosen for this study included depression, anxiety, panic disorder, posttraumatic stress disorder, bipolar, and schizophrenia. RESULTS: Within 3 yrs after a concussion, 48% of patients were later diagnosed with a mental illness. All of the mental illnesses this study chose to evaluate were present in a higher proportion of patients after a concussion than the general population. CONCLUSIONS: The mechanism between concussions and mental illness remains unclear. A large proportion of patients who experience a concussion are later diagnosed with a mental illness within 3 yrs. Patients with a history of a previous concussion may benefit from screening for the development of a mental illness.

Impact of Chemoprophylaxis on Thromboembolism Following Operative Fixation of Pelvic Fractures.

BACKGROUND: Venous thromboembolism (VTE) is a common cause of serious morbidity and mortality. While chemoprophylaxis decreases VTE, there is the theoretical risk of increased hemorrhagic complications. The purpose of this study was to evaluate the impact of preoperative anticoagulation on VTE and bleeding complications in patients with blunt pelvic fractures requiring operative fixation. METHODS: Patients with blunt pelvic fractures requiring operative fixation over 10.5 years were identified. Patients were stratified by age, severity of shock, operative management, and timing and duration of anticoagulation. Outcomes were evaluated to determine risk factors for bleeding complications and VTE. RESULTS: 310 patients were identified: 212 patients received at least one dose of preoperative anticoagulation and 98 received no preoperative anticoagulation. 68% were male with a mean injury severity score and Glasgow Coma Scale of 26 and 13, respectively. Bleeding complications occurred in 24 patients and 21 patients suffered VTE. Patients with VTE had a greater initial severity of shock (resuscitation transfusions, 4 vs. 2 units, P = .02). Despite longer time to mobilization (4 vs. 3 days, P = .001), patients who received their scheduled preoperative doses within 48 hours of arrival had no significant differences in the number of deep vein thrombosis events (5.2% vs. 5.7%, P = .99), but fewer episodes of pulmonary embolism (PE) (1.5% vs. 6.8%, P = .03) with no difference in bleeding complications (7.5% vs. 8%, P = .87) compared to either patients who had their doses held until after 48 hours of arrival or received no preoperative anticoagulation. DISCUSSION: Preoperative anticoagulation prior to pelvic fixation reduced the risk of PE without increasing bleeding complications. Preoperative anticoagulation is safe and beneficial in this group of patients.

Evaluating the optimal training paradigm for transcarotid artery revascularization based on worldwide experience.

BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

Evaluation of Staged TCAR and Cardiac Surgery or Structural Heart Intervention.

INTRODUCTION: The optimal treatment strategy for patients with concomitant carotid and cardiac disease remains controversial. Transcarotid artery revascularization stenting with reversed flow protection (TCAR) has achieved results equivalent to carotid endarterectomy (CEA) in high risk patients. METHODS: A retrospective review of all patients at a single center who received staged TCAR prior to cardiac intervention was performed. RESULTS: 37 patients underwent 42 TCAR procedures prior to cardiac intervention (25 requiring open cardiac surgery and 12 requiring percutaneous intervention). There were no myocardial or neurological complications following TCAR prior to cardiac intervention. Three patients (8%) developed a neck hematoma which required evacuation. CONCLUSION: A staged approach to combined carotid and cardiac pathology with TCAR prior to cardiac intervention appears to be a safe and effective strategy.

Intraoperative repair of mitral paravalvular leak with Amplatzer plug.

BACKGROUND AND AIM OF THE STUDY: Significant paravalvular leaks may complicate mitral valve replacement (MVR), especially in the setting of mitral annular calcification. Correction has been accomplished postoperatively by endovascular delivery of Amplatzer plugs (Abbott Medical) with good results. Intraoperative delivery of Amplatzer plugs at the index operation may reduce postoperative paravalvular leaks. METHODS: A retrospective review of eight patients who underwent placement of Amplatzer plugs for treatment of paravalvular leak during MVR at a single institution is reported. RESULTS: Seven patients had ≤1+ residual mitral valve insufficiency and one patient had 1-2+ residual mitral valve insufficiency intraoperatively by transesophageal echocardiogram. At 222 days average follow-up, echocardiogram revealed ≤ 1+ residual mitral valve insufficiency in all surviving patients. CONCLUSION: Intraoperative delivery of Amplatzer plugs for treatment of paravalvular leaks during MVR appears to be safe and effective at reducing postoperative mitral valve insufficiency.

Extracellular Matrix Patches for Endarterectomy Repair.

Patch repair is the preferred method for arteriotomy closure following femoral or carotid endarterectomy. Choosing among available patch options remains a clinical challenge, as current evidence suggests roughly comparable outcomes between autologous grafts and synthetic and biologic materials. Biologic patches have potential advantages over other materials, including reduced risk for infection, mitigation of an excessive foreign body response, and the potential to remodel into healthy, vascularized tissue. Here we review the use of decellularized extracellular matrix (ECM) for cardiovascular applications, particularly endarterectomy repair, and the capacity of these materials to remodel into native, site-appropriate tissues. Also presented are data from two post-market observational studies of patients undergoing iliofemoral and carotid endarterectomy patch repair as well as one histologic case report in a challenging iliofemoral endarterectomy repair, all with the use of small intestine submucosa (SIS)-ECM. In alignment with previously reported studies, high patency was maintained, and adverse event rates were comparable to previously reported rates of patch angioplasty. Histologic analysis from one case identified constructive remodeling of the SIS-ECM, consistent with the histologic characteristics of the endarterectomized vessel. These clinical and histologic results align with the biologic potential described in the academic ECM literature. To our knowledge, this is the first histologic demonstration of SIS-ECM remodeling into site-appropriate vascular tissues following endarterectomy. Together, these findings support the safety and efficacy of SIS-ECM for patch repair of femoral and carotid arteriotomy.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

A Fast and Furious Bayesian Network and Its Application of Identifying Colon Cancer to Liver Metastasis Gene Regulatory Networks.

Bayesian networks is a powerful method for identifying causal relationships among variables. However, as the network size increases, the time complexity of searching the optimal structure grows exponentially. We proposed a novel search algorithm - Fast and Furious Bayesian Network (FFBN). Compared to the existing greedy search algorithm, FFBN uses significantly fewer model configuration rules to determine the causal direction of edges when constructing the Bayesian network, which leads to greatly improved computational speed. We benchmarked the performance of FFBN by reconstructing gene regulatory networks (GRNs) from two DREAM5 challenge datasets: a synthetic dataset and a larger yeast transcriptome dataset. In both datasets, FFBN shows a much faster speed than the existing greedy search algorithm, while maintaining equally good or better performance in recall and precision. We then constructed three whole transcriptome GRNs for primary liver cancer (PL), primary colon cancer (PC) and colon to liver metastasis (CLM) expression data, which the existing greedy search algorithms failed. Three GRNs contain 12,099 common genes. Unprecedentedly, our newly developed FFBN algorithm is able to build up GRNs at a scale larger than 10,000 genes. Using FFBN, we discovered that CLM has its unique cancer molecular mechanisms and shares a certain degree of similarity with both PL and PC.