Rate Of Thromboembolic Complications Research Articles

Safety and efficacy of the pipeline embolization device for treatment of small vs. large aneurysms: a systematic review and meta-analysis.

Flow diversion with the pipeline embolization device (PED) is increasingly used to treat intracranial aneurysms with high obliteration rates and low morbidity. However, long-term (≥ 1year) angiographic and clinical outcomes still require further investigation. The aim of this study was to compare the occlusion and complication rates for small (< 10mm) versus large (10-25mm) aneurysms at long-term following treatment with PED. A systematic review and meta-analysis were performed in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We conducted a comprehensive search of English language databases including Ovid MEDLINE and Epub Ahead of Print, In-Process, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Our studies included a minimum of 10 patients treated with PED for small vs. large aneurysms and with at least 12months of follow-up. The primary safety endpoint was the rate of clinical complications measured by the occurrence of symptomatic stroke (confirmed clinically and radiographically), intracranial hemorrhage, or aneurysmal rupture. The primary efficacy endpoint was the complete aneurysm occlusion rate. Our analysis included 19 studies with 1277 patients and 1493 aneurysms. Of those, 1378 aneurysms met our inclusion criteria. The mean age was 53.9years, and most aneurysms were small (89.75%; N = 1340) in women (79.1%; N = 1010). The long-term occlusion rate was 73% (95%, CI 65 to 80%) in small compared to 84% (95%, CI 76 to 90%) in large aneurysms (p < 0.01). The symptomatic thromboembolic complication rate was 5% (95%, CI 3 to 9%) in small compared to 7% (95%, CI 4 to 13%) in large aneurysms (p = 0.01). The rupture rate was 2% vs. 4% (p = 0.92), and the rate of intracranial hemorrhage was 2% vs. 4% (p = 0.96) for small vs. large aneurysms, respectively; however, these differences were not statistically significant. The long-term occlusion rate after PED treatment is higher in large vs. small aneurysms. Symptomatic thromboembolic rates with stroke are also higher in large vs. small aneurysms. The difference in the rates of aneurysm rupture and intracranial hemorrhage was insignificant. Although the PED seems a safe and effective treatment for small and large aneurysms, further studies are required to clarify how occlusion rate and morbidity are affected by aneurysm size.

Management of Patients Receiving Antiplatelet Therapy During Gastroenterological Surgery: A Multicenter Prospective Cohort Study (GSATT).

This study aimed to evaluate the effect of continuing preoperative aspirin monotherapy on surgical outcomes in patients receiving antiplatelet therapy (APT). The effectiveness of continuing preoperative aspirin monotherapy in patients undergoing APT in preventing thromboembolic consequences is mostly unknown. This prospective multicenter cohort study on the Safety and Feasibility of Gastroenterological Surgery in Patients Undergoing Antithrombotic Therapy (GSATT study) conducted at 14 clinical centers enrolled and screened patients between October 2019 and December 2021. The participants (n=1170) were assigned to the continued-APT group, discontinued-APT group, or non-APT group, and the surgical outcomes of each group were compared. Propensity score matching was performed between the continued and discontinued-APT groups to investigate the effect of continuing preoperative aspirin therapy on thromboembolic complications. The rate of thromboembolic complications in the continued-APT group was substantially lower than that in the non-APT or discontinued-APT groups (0.5% vs 2.6% vs. 2.9%; P =0.027). Multivariate investigation of the entire cohort revealed that discontinuation of APT ( P <0.001) and chronic anticoagulant use ( P <0.001) were independent risk factors for postoperative thromboembolism. The post-matching evaluation demonstrated that the rates of thromboembolic complications were significantly different between the continued and discontinued-APT groups (0.6% vs 3.3%; P =0.012). APT discontinuation after elective gastroenterological surgery increases the risk of thromboembolic consequences, whereas continuing preoperative aspirin greatly reduces this risk. The continuation of preoperative aspirin therapy in APT-received patients is considered one of the best alternatives for preventing thromboembolism during elective gastroenterological surgery.

Efficacy and Safety of Dual Antiplatelet Therapy with the Routine Use of Prasugrel for Flow Diversion of Cerebral Unruptured Aneurysms

PurposePrasugrel is not approved for patients treated with flow diverters, which have a high metal coverage ratio. However, robust antiplatelet therapy with prasugrel may prevent thromboembolic complications. We administered prasugrel and aspirin to all patients treated with flow diverters and reported the safety of the antiplatelet therapy regimen.MethodsThis retrospective, single-center study evaluated the angiographic and clinical data of consecutive patients treated with flow diverters for cerebral unruptured aneurysms between June 2020 and May 2022. All patients received dual antiplatelet therapy, including prasugrel and aspirin. The administration of prasugrel ended 3 or 6 months after the procedure, whereas aspirin use continued for at least 12 months. Periprocedural complications (< 30 days post-procedure) and delayed complications (> 30 days post-procedure) were recorded.ResultsDuring the study period, 120 unruptured aneurysms were treated with flow diverters in 110 patients. All patients, except one, survived longer than 12 months after the procedure. The rate of thromboembolic complications was 6.4%, and more than half of the patients had transient symptoms; one (0.9%) had a major ischemic stroke. One patient (0.9%) each had an asymptomatic, small subarachnoid hemorrhage and significant hemorrhagic complications with melena. The rate of permanent neurological deficits was 1.8%, and the mortality rate was 0.9%.ConclusionsDual antiplatelet therapy comprising routine use of prasugrel and aspirin for flow diverter-implanted patients possibly contributed to a low rate of thromboembolic complications and low risk of hemorrhagic complications.

Perioperative continuation or ultra-early resumption of antithrombotics in elective neurosurgical cranial procedures.

Discontinuation of antithrombotics (AT) prior to elective cranial procedures is common practice, despite the higher risk of thromboembolic complications in these patients. The aim of this study was to investigate the risks and benefits of a new perioperative management protocol of continuation or ultra-early AT resumption in elective cranial procedures. This study was an analysis of a prospectively collected cohort of patients undergoing elective cranial surgery with (AT group) and without (control group) AT. For extraaxial or shunt surgeries, acetylsalicylic acid (ASA) was continued perioperatively. For intraaxial pathologies, ASA was discontinued 2 days before surgery and resumed on postoperative day 3. All other AT were discontinued according to their pharmacokinetics, and resumed on postoperative day 3 after unremarkable postoperative imaging. Additionally, the authors performed a retrospective analysis of patients with AT who underwent surgery before implementation of this new AT management protocol (historical AT group). Primary and secondary outcomes were the incidence of hemorrhagic and thromboembolic complications within 3 months after surgery. Outcomes of 312 patients were analyzed (83 [27%] in the AT group, 106 [34%] in the control group, and 123 [39%] in the historical AT group). For all 3 patient groups, the most common type of surgery was craniotomy for intraaxial tumors (14 [17%] in the AT group, 28 [26%] in the control group, and 60 [49%] in the historical AT group). The most commonly used AT were ASA (38 [46%] in the AT group and 78 [63%] in the historical AT group), followed by non-vitamin K oral anticoagulants (32 [39%] in the AT group and 18 [15%] in the historical AT group). The total perioperative discontinuation time in the AT group was significantly shorter than in the historical AT group (median of 4 vs 16 days; p < 0.001). The rate of hemorrhagic complications was 4% (95% CI 1-10) (n = 3/83) in the AT group, 6% (95% CI 2-12) (n = 6/106) in the control group, and 7% (95% CI 3-13) (n = 9/123) in the historical AT group (p = 0.5). The rate of thromboembolic complications was 5% (95% CI 1-12) (n = 4/82) in the AT group, 8% (95% CI 3-15) (n = 8/104) in the control group, and 7% (95% CI 3-13) (n = 8/120) in the historical AT group (p = 0.7). The presented perioperative management protocol of continuation or ultra-early resumption of AT in elective cranial procedures does not seem to increase the hemorrhagic risk. Moreover, it appears to potentially protect patients from thromboembolic complications.

Oversizing of the Woven EndoBridge for Treatment of Intracranial Aneurysms Improves Angiographic Results (WEBINAR)

Several studies have demonstrated a high safety and efficacy profile of the Woven EndoBridge (WEB) for endovascular aneurysm treatment. However, contemporary large-scale studies of the WEB are rare. This multicenter study attempts to set a benchmark for state-of-the-art WEB treatment with consistent application of the WEB oversizing technique. This is a retrospective, multicenter study of aneurysms (dome width 2-10mm) treated with the WEB between 2015 and 2023. Patient and aneurysm characteristics, complications, and clinical and angiographic outcomes were analyzed. The study consisted of 247 patients treated for 251 aneurysms (25.5% ruptured, 5.6% recurrent). WEB implantation was feasible in 98.8%, achieving a mean WEB/dome ratio of 1.2±0.1. The thromboembolic complication rate was 7.2%, which was higher in ruptured versus unruptured aneurysms (hazard ratio: 2.8, 95%CI: 1.0-7.6, P= 0.04), but lower in cases where WEB 17 was used (hazard ratio: 4.0, 95%CI: 1.4-11.2, P= 0.01). Neurological complications occurred in 8 procedures (3.2%), including 3 (1.2%) major, and 5 (2.0%) minor events. Procedural morbidity and mortality were 0.8% and 0%, respectively. Mid-term complete and adequate occlusion rates were 66.3% and 88.4%, respectively. The retreatment rate was 5.2%. Feasibility, complication, and occlusion rates were comparable between typical and atypical aneurysm locations. Oversizing the WEB and using currently available WEB types in this series resulted in slightly better treatment outcomes compared to early WEB studies, confirming the high safety, feasibility, and efficacy of this technique.

Efficacy of the Hepcon system in reducing hemorrhagic and thrombotic complications in antiphospholipid syndrome patients undergoing cardiac surgery.

Patients with Antiphospholipid Syndrome (APS) undergoing cardiopulmonary bypass (CPB) surgery are at increased risk for thrombotic and hemorrhagic complications. Anticoagulation during CPB is typically monitored with activated clotting time (ACT) which may be falsely prolonged in patients with APS. The Hepcon Hemostasis Management System quantitatively determines the whole blood heparin concentration through heparin/protamine titration. This was a retrospective study of APS patients who underwent cardiac surgery requiring CPB at the Cleveland Clinic between April 2013, and July 2020. The primary endpoint was the composite rate of hemorrhagic or thromboembolic complications per surgical case in patients monitored by Hepcon versus patients monitored by ACT. Secondary endpoints were median volume of chest tube output and packed red blood cell (PRBC) transfusion within the first three post-operative days. 43 patients were included. 20 (47%) patients were monitored using Hepcon while 23 (53%) were monitored using ACT. For the primary endpoint of rate of thromboembolic or hemorrhagic complications per surgical case, there was no statistically significant difference between the Hepcon and ACT groups (HMS, 6/20 [30%]; ACT, 7/23 [30%]; p = >0.99). For the secondary endpoints, there was no statistically significant difference in median post-operative chest tube output (780mL vs. 850mL; p = 0.88) and median post-operative PRBC transfusion (1 unit vs. 0 unit; p = 0.28) between the Hepcon and ACT groups, respectively. There was no difference in the composite outcome of thrombotic or hemorrhagic complications in patients monitored by Hepcon versus those monitored by ACT.

Embolization of unruptured wide-necked aneurysms at the MCA bifurcation using the Neuroform atlas stent-assisted coiling: a two-center retrospective study.

The management of middle cerebral artery (MCA) aneurysms remains a controversial topic, and MCA aneurysms have traditionally been treated primarily by surgical clipping. The Neuroform Atlas Stent™ (NAS, available from Stryker Neurovascular, Fremont, California) represents the latest generation of intracranial stents with improved stent delivery system capabilities. This study aims to investigate the safety, feasibility and efficacy exhibited by NAS in treating unruptured aneurysms at the MCA bifurcation. This was a two-center retrospective study involving 42 patients with unruptured wide-necked aneurysms (WNAs) of the MCA treated with the NAS from October 2020 to July 2022. The stent was used to treat 42 cases of unruptured WNA at the MCA bifurcation. Endovascular treatment techniques had a 100% success rate. Immediate postoperative angiography found complete aneurysm occlusion in 34 patients (80.9%) (mRRC 1), neck remnant in 7 patients (16.7%) (mRRC 2), and residual aneurysm in 1 patient (2.4%) (mRRC 3). The thromboembolic complication rate was 2.4% (1/42). The follow-up period was 8.7 months on average (3-16 months). The last angiographic follow-up results revealed complete aneurysm occlusion in 39 patients (92.9%) (mRRC 1), neck remnant in 3 (7.1%) patients (mRRC 2), no aneurysm recanalization or recurrence, and no cases of stent intimal hyperplasia. During the latest clinical follow-up, all patients had an mRS score of 0. Our study demonstrates that the NAS can be applied to treat unruptured WNAs at the MCA bifurcation with favorable safety, feasibility, and efficacy.

Coiling Variations for Treatment of Ruptured Intracranial Aneurysms: A Meta-Analytical Comparison of Comaneci-, Stent-, and Balloon-Coiling Assistance Techniques

Wide-necked aneurysms represent a challenge for treatment in the setting of acute subarachnoid hemorrhage. Stent-assisted coiling (SAC) and balloon-assisted coiling (BAC) are well-known techniques for treating wide-necked aneurysms. Comaneci-assisted coiling (CAC) is a newer technique involving temporary stent deployment to assist aneurysm coiling. We aim to present the first meta-analysis comparing these treatments of ruptured aneurysms. Following PRISMA guidelines, PubMed and Embase databases were queried from earliest records to July 2022 for literature reporting SAC, BAC, or CAC of ruptured intracranial aneurysms. A meta-analysis of identified articles was performed. Of the 571 articles queried, 64 articles were included. One study reported BAC and SAC, 8 reported BAC, 52 reported SAC, and 3 reported CAC. These studies comprised 3153 patients with 3207 ruptured aneurysms treated with CAC (161 patients and aneurysms), BAC (330 patients and aneurysms), and SAC (2662 patients, 2716 aneurysms). Rates of periprocedural thromboembolic or hemorrhagic complications, overall or procedure-related mortality, immediate complete occlusion, retreatment, and length of angiographic follow-up did not differ significantly between SAC and BAC. Periprocedural thromboembolic (P= 0.03) and hemorrhagic (P= 0.01) complication rates were higher with BAC than CAC. Periprocedural thromboembolic (P= 0.03) and hemorrhagic (P < 0.0001) complication rates were higher with SAC than CAC. Complete aneurysm occlusion rates (P= 0.033) were higher with CAC than BAC. No significant differences were present in CAC versus BAC or SAC retreatment rates. CAC was associated with lower hemorrhagic and thromboembolic complication rates and demonstrated similar complete occlusion and residual retreatment rates to those for BAC and SAC.

396 North American Multicenter Experience of the Flow-Redirection Endoluminal Device (FRED) in the Treatment of Intracranial Aneurysms

INTRODUCTION: Flow-diverters have revolutionized the endovascular treatment of intracranial aneurysms. The evidence on the Flow Re-direction Endoluminal Device (FRED) is limited compared to some counterparts that have been available for clinical use longer. METHODS: Between June 2020 and November 2021, consecutive cerebral aneurysms treated using FRED were included across 7 North American centers. Data collected included patient demographics, aneurysm characteristics, peri-procedural and long-term complications, modified Rankin Scale (mRS) scores, and radiologic follow-up. RESULTS: 133 aneurysms in 116 patients treated in 123 FRED deployment procedures were included. One hundred twenty-six aneurysms (94.7%) were unruptured, 117 (88.0%) were saccular, and 123 (92.5%) aneurysms were located in the anterior circulation. Mean aneurysm maximal width and neck sizes were 7.2 mm and 4.1 mm, respectively. Successful FRED deployment was achieved in 122 (99.2%) procedures. Radiologic follow-up was available for 101 aneurysms at a median duration of 7.0 months. At the last follow-up, complete occlusion was observed in 55.4%, residual neck in 8.9%, and filling aneurysm in 35.6%. On multivariate regression analysis, age (OR = 0.93; p = 0.001) and aneurysm neck size (OR = 0.83; p = 0.048) negatively correlated with odds of complete occlusion. The retreatment rate was 6/124 (4.8%). The overall complication rate was 31/116 (26.7%). Parent vessel occlusion, covered branch occlusion, and in-stent stenosis were detected in 9/99 (9.1%), 6/63 (9.5%), and 15/99 (15.2%) of the cases, respectively. FRED-related, symptomatic, thromboembolic, and hemorrhagic complication rates were 22.4%, 12.9%, 6.9%, and 0.9% respectively. The morbidity rate was 10/116 (8.6%). CONCLUSIONS: As the first large-scale North American multi-center FRED experience, this study confirms FRED’s ease of successful deployment but suggests a lower efficacy and higher rate of complications compared to previous European and South American FRED studies and other flow diverting devices.

Atrial fibrillation in cancer: thromboembolism and bleeding in daily practice

BackgroundCancer is suggested to confer thromboembolic and bleeding risk in patients with atrial fibrillation (AF). ObjectivesWe aimed to describe current anticoagulant practice in patients with AF and active cancer, present incidences of thromboembolic and bleeding complications, and evaluate the association between cancer type or anticoagulant management strategy with AF-related complications. MethodsThis retrospective study identified patients with AF and active cancer in 2 hospitals between January 1, 2012, and December 31, 2017. Follow-up lasted for 2 years. Data on cancer and anticoagulant treatment were collected. The outcomes of interest included ischemic stroke or transient ischemic attack (TIA) and clinically relevant nonmajor bleeding (CRNMB/MB). Incidence rates (IRs) per 100 patient-years and subdistribution hazard ratios (SHRs) with corresponding 95% Cis were estimated. ResultsWe identified 878 patients with AF who developed cancer (cohort 1) and 335 patients with cancer who developed AF (cohort 2). IRs for ischemic stroke/TIA and MB/CRNMB were 3.9 (2.8-5.3) and 15.7 (13.3-18.5) for cohort 1 and 4.0 (2.2-6.7) and 16.7 (12.6-21.7) for cohort 2. 14.2% (cohort 1) and 19.1% (cohort 2) of patients with a CHA2DS2-VASc score of ≥2 did not receive anticoagulant treatment. Withholding anticoagulants was associated with thromboembolic complications (SHR: 5.1 [3.20-8.0]). In nonanticoagulated patients with a CHA2DS2-VASc score of <2, IRs for stroke/TIA were 4.5 (0.75-15.0; cohort 1) and 16.0 (5.1-38.7; cohort 2). ConclusionPatients with AF and active cancer experience high rates of thromboembolic and bleeding complications, underlying the complexity of anticoagulant management in these patients. Our data suggest that the presence of cancer is an important factor in determining the indication for anticoagulants in patients with a low CHA2DS2-VASc score.

Multicenter experience with andexanet alfa for refractory pericardial bleeding during catheter ablation of atrial fibrillation.

Pericardial bleeding is a rare but life-threatening complication of atrial fibrillation (AF) ablation. Patients taking uninterrupted oral anticoagulation (AC) may be at increased risk for refractory bleeding despite pericardiocentesis and administration of protamine. In such cases, andexanet alfa can be given to reverse rivaroxaban or apixaban. In this study, we aim to describe the rate of acute hemostasis and thromboembolic complications with andexanet for refractory pericardial bleeding during AF ablation. In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 h of AF ablation, developed refractory pericardial bleeding during the procedure despite pericardiocentesis and administration of protamine and received andexanet. Eleven patients met inclusion criteria, with mean age of 73.5 ± 5.3 years and median CHA2 DS2 -VASc score 4 [3-5]. All patients received protamine and pericardiocentesis, and 9 (82%) received blood products. All patients received a bolus of andexanet followed, in all but one, by a 2-hinfusion. Acute hemostasis was achieved in eight patients (73%) while three required emergent surgery. One patient (9%) experienced acute ST-elevation myocardial infarction after receiving andexanet. Therapeutic AC was restarted after a mean of 2.2 ± 1.9 days and oral AC was restarted after a mean of 2.9 ± 1.6 days, with no recurrent bleeding. In patients on uninterrupted apixaban or rivaroxaban, who develop refractory pericardial bleeding during AF ablation, andexanet can achieve hemostasis thereby avoiding the need for emergent surgery. However, there is a risk of thromboembolism following administration.

A comparison of antiplatelet therapy during the peri- and post-operative periods following flow-diverting stent insertion for unruptured intracranial aneurysms: A systematic review.

Flow diverters (FDs) are neuroendovascular stents indicated for the management of unruptured intracranial aneurysms. Due to their composition, dual antiplatelet therapy (DAPT) is essential during the peri- and post-operative periods to prevent thromboembolic events. However, there is limited consensus within the scientific community regarding which antiplatelets to use and dosing following neuroendovascular treatment of aneurysms. A systematic search of four electronic databases was conducted during November 2020 that included studies published between January 2010 and November 2020. Eligibility for inclusion included primary research articles, published in the English language and use of flow-diverting intracranial stents. Studies were excluded if they utilised combined therapies (e.g. FD with stent-assisted coiling), animal studies, clinical trial protocols and study population of less than 10 subjects. Eighteen studies were identified for inclusion with a total of 1312 patients with 1355 unruptured intracranial aneurysms treated with FDs. Of these, 13 studies primarily investigated the use of clopidogrel with aspirin with low rates of haemorrhagic and thromboembolic complications. A forest plot of nine of these studies showed average efficacy of 88% at 95% confidence interval (CI) (SD + 5%) with 63% heterogeneity. The large proportion of studies investigating clopidogrel and aspirin antiplatelet therapy presents a challenge in comparing antiplatelet regimens. Although prasugrel and ticagrelor have been identified as suitable alternatives to clopidogrel, these were based on studies with small cohort sizes. Glycoprotein IIb/IIIa inhibitors may be efficacious as rescue therapy for intra-procedural thrombosis. Further research is required to determine which antiplatelet is most suitable.

783: COMPARATIVE COHORT STUDY OF REVERSAL AGENTS FOR BLEEDING ASSOCIATED WITH FACTOR XA INHIBITORS

Introduction: While andexanet alfa (AA) is approved for reversal of bleeding associated with factor Xa inhibitors, rates of mortality, efficacy, and thrombotic events from retrospective studies evaluating AA and four factor prothrombin complex concentrate (PCC) are similar, with significant differences noted in cost between agents. However, many of these studies have low power and competing findings. This study sought to characterize all-cause mortality, efficacy, and morbidity of patients administered AA and PCC within a single hospital network. Methods: This was a retrospective cohort study of adult patients administered AA or PCC between October 2018 and June 2020 for reversal of bleeding associated with factor Xa inhibitor usage. Patients were excluded if reversal was attempted prior to an emergent operation. The primary endpoint was hospital mortality, with concurrent evaluation of 60-day all-cause mortality, thrombotic event rates, and discharge disposition. Results: 142 patients presented with bleeding requiring anticoagulation reversal within the study period. 94 patients received PCC and 48 patients received AA. Patient groups were similar with regards to all demographic characteristics except for gender, and had similar Glasgow Coma Scale (GCS) and Charlson Comorbidity Index (CCI) scores. Traumatic injury causing bleeding was noted in 44.7% vs 41.7% of PCC vs AA patients (p=0.732). Central nervous system (CNS) bleeds were noted in 43.6% vs 43.8% of PCC and AA patients, with similar rates of CNS, gastrointestinal (GI), and other locations of bleeding between groups. Efficacy within 48 hours was 75.9% vs 82.4% for PCC and AA in patients with CNS bleeding. In-hospital mortality was higher for patients receiving AA (14.9% vs 27.1%, p=0.006), with similar 60-day mortality, hospital length of stay (LOS), rates of thrombotic events, and discharge disposition. Average cost of AA across study patients was $36,094, while the average cost of PCC was $5,596 (p< 0.001). Conclusions: AA is associated with higher mortality compared to PCC, although with similar rates of thromboembolic complications and efficacy. The mortality difference requires further investigation for confirmation. The cost of AA was higher in comparison to PCC.

Associations between SARS-CoV-2 infections and thrombotic complications necessitating surgical intervention: A systematic review.

Several unique clinical features of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19) infection, have been identified and characterized. One such feature, mostly among patients with severe COVID-19 infection, has become known as COVID-19-induced coagulopathy. Surgical patients with a history of or active COVID-19 infection bear a significantly higher risk for postoperative thrombotic complications. These patients may require surgical intervention to treat severe thrombotic complications. Few studies have been carried out to better characterize this association. The purpose of this study was to perform a systematic review and meta-analysis of the literature on COVID-19 infections that led to thrombotic complications necessitating surgical intervention. We hypothesized that patients with recent or active COVID-19 infection would have high rates of thromboembolic complications both arterial and venous in origin. To perform a systematic review and meta-analysis of the literature on COVID-19 infections that led to thrombotic complications necessitating surgical intervention. The current systematic review implemented an algorithmic approach to review all the currently available English medical literature on surgical interventions necessitated by COVID-19 thrombotic complications using the preferred reporting items for systematic reviews and meta-analysis principles. A comprehensive search of the medical literature in the "PubMed", "Scopus", "Google Scholar" top 100 results, and archives of Plastic and Reconstructive Surgery was performed using the key words "COVID-19" AND "surgery" AND "thromboembolism" AND "complication". The search string was generated and the records which were not specific about surgical interventions or thrombotic complications due to COVID-19 infection were excluded. Titles and abstracts were screened by two authors and full-text articles were assessed for eligibility and inclusion. Finally, results were further refined to focus on articles that focused on surgical interventions that were necessitated by COVID-19 thrombotic complications. The database search resulted in the final inclusion of 22 retrospective studies, after application of the inclusion/exclusion criteria. Of the included studies, 17 were single case reports, 3 were case series and 2 were cross sectional cohort studies. All studies were retrospective in nature. Twelve of the reported studies were conducted in the United States of America, with the remaining studies originating from Italy, Turkey, Pakistan, France, Serbia, and Germany. All cases reported in our study were laboratory confirmed SARS-CoV-2 positive. A total of 70 cases involving surgical intervention were isolated from the 22 studies included in this review. There is paucity of data describing the relationship between COVID-19 infection and thrombotic complications necessitating the need for surgical intervention. Intestinal ischemia and acute limb ischemia are amongst the most common thrombotic events due to COVID-19 that required operative management. An overall postoperative mortality of 30% was found in those who underwent operative procedures for thrombotic complications, with most deaths occurring in those with bowel ischemia. Physicians should be aware that despite thromboprophylaxis, severe thrombotic complications can still occur in this patient population, however, surgical intervention results in relatively low mortality apart from cases of ischemic bowel resection.

Thromboembolic Complications PICC-Related in Adult Patients Affected By Hematologic Diseases: A 13-Years Monocentric Experience

Background: Currently, Peripheral Insertion Central Venous Catheters (PICCs) represents the device of choice for the treatment of hematologic patients because of lower risk of complications, easier management in outpatient population compared to Centrally Inserted Central Venous Catheters (CICCs) and effectiveness in performing high-risk therapy as hematopoietic stem cell transplantation. Introduction: PICC insertion and use could be characterized by the occurrence of complications, whose most dangerous are the systemic and local infections and thromboembolic (TE) manifestations. The aim of this study is to evaluate the incidence of TE complications and the risk factors associated to their development. Methods: Since the 2007, a PICC team, consisting of a hematology physician and three dedicated nurses has carried out a prospective study to evaluate complication rate and usefulness of PICC device in the hematology clinical practice. Inclusion criteria included all hematologic inpatient and outpatient who needed program of chemo-radiotherapy, support treatment and HSCT, regardless of white blood cells (WBC) and platelets (PLT) counts. All patients underwent a previous evaluation of arms vascular anatomy by ultrasonography. All implantation procedures were performed under ultrasound guide with radiographic control following insertion. The TE complications were diagnosed in clinical suspicion with venous color-doppler ultrasound and, if necessary, vascular CT scan. The therapy was performed according to local guidelines. The duration of PICC life is reported as 1000 days/PICC. The statistical analysis were performed with R software (R core team 2021). Results: From March 2007 to June 2020, 1132 PICC implantation were performed in 983 hematologic patients (545 male and 438 females). Median age was 56 years, range 15-94. The most representative diseases were non-Hodgkin Lymphoma (NHL) (332 patients, 33,8%), Hodgkin Lymphoma (HL) (276 patients, 28%), Multiple Myeloma (MM) (127 patients, 12,9%), Acute Myeloid Leukemia (AML) (107 patients, 11%). Seven hundred and eighten PICCs (63.4%) were inserted in patients that underwent a previous therapy. Nine hundred and ten PICCs (80,4%) were used for chemo-radiotherapy courses, 95 (8,4%) for support treatment, 111 (9,8%) for autologous hemopoietic stem cell transplantation (HSCT), 15 (1,3%) for allogenic HSCT, 1 for auto-allo HSCT (0.09%). PICC median life was 133 days (range 1-1257) for a total of 156485 days. Forty-two PICCs were lost at follow up and for this reason the analysis about duration and complication was performed on 1090 devices. At the time of this analysis 25 PICCs (2,3%) are still in situ and in use, 754 (69,2%) were removed for end of therapy, 94 (8,6%) for accidental withdrawals, 130 (11,9%) for death, 1 (0,1%) for patient decision. Only 86 PICCs (7,9%) were removed because of catheter related complications: 4 (0,36%) for catheter rupture, 25 (2,3%) for malfunctioning/occlusion, 11 (1%) for malposition, 7 (0,64%) for local infection, 3 (0,3%) for confirmed PICC-related sepsis 36 (3,3%) for suspected PICC-related sepsis. There were only 30 episodes (2,7%; 0,19/1000 days/PICC) of symptomatic PICC-related thrombotic complications, without need of removal. The TE complications were described in PICC inserted in patients affected by HL (11 PICCs, 36.3%), NHL (9, 30%), MM (5, 16,7%), AML (2, 6,7%), promyelocitic leukemia (2, 6,7%), non neoplastic anemia (1, 3,4%). The univariate analysis shown a strong association between the TE complications and the duration of PICC life (Tab. 1). The multivariate analysis confirm this data with a demonstration that a diagnosis of HL and the age at time of insertion could be considered as risk factors for the onset of TE disease (Tab.1). Conclusions. These data shown that the rate of TE complications in our experience in adult hematologic patients is very low, no impacting on the safety of patients and usefulness of the devices. The advanced age of patients, duration of PICC life and HL diagnosis seem to be risk factor for the onset of TE manifestations PICC-related. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Efficacy of the Hepcon System in Reducing Hemorrhagic and Thrombotic Complications in Antiphospholipid Syndrome Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Introduction: Patients with Antiphospholipid Syndrome (APS) undergoing cardiopulmonary bypass (CPB) surgery are at increased risk for thrombotic and hemorrhagic complications. Heparin concentration during CPB is typically monitored by the activated clotting time (ACT), however, antiphospholipid antibodies have the potential to alter the baseline ACT. The Hepcon Hemostasis Management System (HMS) utilizes an individualized heparin dose-response curve to estimate free plasma heparin levels and has been shown to correlate well with anti-Xa levels. The purpose of this study is to evaluate the efficacy of Hepcon HMS in reducing thrombotic and hemorrhagic complications in APS patients undergoing cardiac surgery requiring CPB in a large cardiac surgery referral center. Herein, we report the largest cohort study to date of APS patients monitored with Hepcon HMS during CPB surgery. Methods: We performed a retrospective study of APS patients who underwent cardiac surgery requiring CPB at the Cleveland Clinic between April 2013 and July 2020. Two sets of antiphospholipid (APL) antibody labs spaced at least 12 weeks apart, or one set of APL labs in addition to historical elevated antibodies must have been present for inclusion. Vascular thrombosis or pregnancy morbidity (defined by revised Sapporo criteria) must have been documented for inclusion. The Hepcon HMS was utilized for intraoperative (intra-op) anticoagulation monitoring at the discretion of the cardiothoracic surgeon, anesthesiologist, and perfusionist. Data including blood product administration, thromboembolic, and major hemorrhagic complications were collected from the intra-op period through post-operative (post-op) day 30. Major hemorrhage was defined using the International Society on Thrombosis and Haemostasis criteria. The primary endpoint was the composite rate of thromboembolic or hemorrhagic complications per surgical case in patients monitored by Hepcon HMS vs. patients monitored by point-of-care-ACT. Secondary endpoints were median volume of chest tube output and packed red blood cell (PRBC) transfusion within the first 3 post-op days. Continuous and categorical variables were analyzed using Wilcoxon rank sum test and Fisher's exact test, respectively. Results: Of 201 screened patients, 43 met inclusion criteria. Of the 43 patients, 20 (47%) patients were monitored using Hepcon HMS during CPB surgery while 23 (53%) were monitored using point-of-care ACT. The two groups did not have a statistically significant difference in baseline characteristics including gender, comorbidities, age, and pre-op ACT, body mass index, creatinine, hemoglobin, and platelet count. The presence of triple positive APL antibody profile was statistically significant between the two groups with 11 such patients in the Hepcon HMS group and 2 such patients in the ACT group (p = .001). Surgical characteristics including total pump time, total cross clamp time, procedure type, and intra-op PRBC transfusion were not significantly different between the two groups. For the primary endpoint, there was no statistically significant difference between the Hepcon HMS and ACT groups (Hepcon HMS 6/20 [30%]; ACT 7/23 [30%]; p = >.99). For the secondary endpoints, there was no statistically significant difference in median post-op chest tube output (780mL vs. 850mL; p = .88) and median post-op PRBC transfusion (1 unit vs. 0 unit; p = .28) between the Hepcon HMS and ACT groups, respectively. Subgroup analysis of patients with triple positive APL antibody profile did not show a statistically significant difference in rate of complications between those monitored with Hepcon HMS vs. those monitored by ACT (27% vs. 50%, p = .54). Conclusion: In this largest to date cohort study of APS patients who underwent CPB surgery, there was no difference in the composite outcome of thrombotic or hemorrhagic complications in patients monitored by Hepcon HMS vs. those monitored by ACT. Both groups had a high rate of complications, which highlights the high-risk nature of this patient population. Prospective randomized trials are warranted to better define optimal heparin concentration monitoring during CPB surgery in APS patients. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Tranexamic acid in pertrochanteric fractures: a retrospective analysis of perioperative outcomes after fixation with a proximal femoral nail

BackgroundTreatment of pertrochanteric femoral fractures is often associated with significant blood loss. It has already been demonstrated that the administration of tranexamic acid (TXA) for endoprosthetic procedures reduces blood losses and leads to a decreased frequency of postoperative complications. The aim of this study is to demonstrate whether the administration of TXA as part of osteosynthesis treatment for pertrochanteric fractures using a proximal femoral nail reduces perioperative blood losses and haemorrhage-related complications.MethodsIn a two-centre retrospective cohort study, 1 g TXA i.v. was administered preoperatively to 294 patients who had suffered from pertrochanteric femoral fractures. The subjects were compared clinically to a historical control group who did not receive TXA (nonTXA). Outcomes were evaluated on the basis of perioperative blood loss, transfusion requirement, and occurrence of complications.ResultsThe TXA group showed evidence of a reduction in blood loss (TXA = 0.97 ± 0.47 l; nonTXA = 1.06 ± 0.47 l; p = 0.004) and a lower frequency of transfusion (TXA = 20%; nonTXA = 31%; p = 0.032) as compared to the nonTXA group. However, evidence of this therapeutic effect could only be demonstrated at one of the centres on subgroup comparison between the two centres. At the second centre, the data did not show a significant difference. A trend could be seen towards a reduction in postoperative renal failure. No complications occurred resulting from the administration of tranexamic acid.ConclusionPreoperative administration of TXA does not lead to an increased rate of thromboembolic complications when applied for treatment of pertrochanteric femoral fractures. Evidence of a positive effect could be seen in principle in relation to the reduction in perioperative blood loss and the frequency of transfusion. The difference in effect between the two centres remains to be clarified: for this reason, it is possible to assume that further factors influencing the efficacy of TXA administration are at play which were not taken into account in this study.

The Pipeline Embolization Device: a decade of lessons learned in the treatment of posterior circulation aneurysms in a multicenter cohort.

The Pipeline Embolization Device (PED) has prompted a paradigm shift in the approach to posterior circulation aneurysms. The year 2021 marks a decade since FDA approval of this flow diverter, and during this time operators have adapted to its off-label uses. The authors examined whether case selection, practice trends, and patient outcomes have changed over this 10-year period. This study is a retrospective review of consecutive posterior circulation aneurysms managed with the PED at four academic institutions in the US between January 1, 2011, and January 1, 2021. Factors related to case selection, rates of aneurysm occlusion, or complications were identified and evaluated. Angiographic outcomes as well as thromboembolic and hemorrhagic complications were investigated. This study included 117 patients (median age 60 years). At a median follow-up of 12 months, adequate occlusion (> 90%) was attained in 73.2% of aneurysms. Aneurysm occlusion rates were similar over the study interval. Thromboembolic and hemorrhagic complications were reported in 12.0% and 6.0% of the procedures, respectively. There was a nonsignificant trend toward a decline in the rate of thromboembolic (14.1% in 2011-2015 vs 9.4% in 2016-2021, p = 0.443) and hemorrhagic (9.4% in 2011-2015 vs 1.9% in 2016-2021, p = 0.089) complications. The authors observed a trend toward a decline in the rate of thromboembolic and hemorrhagic complications with improved operator experience in using the PED for posterior circulation aneurysms. The use of single-device PED flow diversion significantly increased, as did the tendency to treat smaller aneurysms and observe large unruptured fusiform/dolichoectatic lesions. These findings reflect changes attributable to evolving judgment with maturing experience in PED use.

Transradial versus transfemoral access for embolization of intracranial aneurysms with the Woven EndoBridge device: a propensity score-matched study.

Transradial access (TRA) is commonly utilized in neurointerventional procedures. This study compared the technical and clinical outcomes of the use of TRA versus those of transfemoral access (TFA) for intracranial aneurysm embolization with the Woven EndoBridge (WEB) device. This is a secondary analysis of the Worldwide WEB Consortium, which comprises multicenter data related to adult patients with intracranial aneurysms who were managed with the WEB device. These aneurysms were categorized into two groups: those who were treated with TRA or TFA. Patient and aneurysm characteristics and technical and clinical outcomes were compared between groups. Propensity score matching (PSM) was used to match groups according to the following baseline characteristics: age, sex, subarachnoid hemorrhage, aneurysm location, bifurcation aneurysm, aneurysm with incorporated branch, neck width, aspect ratio, dome width, and elapsed time since the last follow-up imaging evaluation. This study included 682 intracranial aneurysms (median [interquartile range] age 61.3 [53.0-68.0] years), of which 561 were treated with TFA and 121 with TRA. PSM resulted in 65 matched pairs. After PSM, both groups had similar characteristics, angiographic and functional outcomes, and rates of retreatment, thromboembolic and hemorrhagic complications, and death. TFA was associated with longer procedure length (median 96.5 minutes vs 72.0 minutes, p = 0.006) and fluoroscopy time (28.2 minutes vs 24.8 minutes, p = 0.037) as compared with TRA. On the other hand, deployment issues were more common in those treated with TRA, but none resulted in permanent complications. TRA has comparable outcomes, with shorter procedure and fluoroscopy time, to TFA for aneurysm embolization with the WEB device.

Antithrombotic therapy for durable left ventricular assist devices - current strategies and future directions.

Left ventricular assist devices (LVADs) improve survival and quality of life for patients with advanced heart failure but are associated with high rates of thromboembolic and hemorrhagic complications. Antithrombotic therapy is required following LVAD implantation, though practices vary. Identifying a therapeutic strategy that minimizes the risks of thromboembolic and hemorrhagic complications is critical to optimizing patient outcomes and is an area of active investigation. This paper reviews strategies for initiating and maintaining antithrombotic therapy in durable LVAD recipients, focusing on those with centrifugal-flow devices.