Protamine Does Not Increase Risk of Stroke in Patients With Elective Carotid Stenting

McDonald, Jennifer S.; Kallmes, David F.; Lanzino, Giuseppe; Cloft, Harry J.

doi:10.1161/strokeaha.113.001188

Cited by 10 publications

(6 citation statements)

References 15 publications

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“…The use of protamine has been shown to be safe in carotid revascularization and its routine use is in fact recommended during TCAR. 18,19 If protamine is utilized during TCAR, the overall rates of hematoma (1.0 to 1.5%) formation remains low regardless of the type of anesthesia.…”

Section: Discussionmentioning

confidence: 99%

The study of transcarotid artery revascularization under local versus general anesthesia with results from the Society for Vascular Surgery Vascular Quality Initiative

et al. 2020

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Objective The primary purpose of this study was to examine any potential difference in clinical outcomes between transcarotid artery revascularization performed under local anesthesia compared with general anesthesia by utilizing a large national database. Methods The primary outcome of the study was a composite endpoint of postoperative in-hospital stroke, myocardial infarction and mortality following transcarotid artery revascularization for the index procedure. Secondary outcomes included a composite outcome of postoperative in-hospital stroke, transient ischemic attack, myocardial infarction and mortality along with several subsets of its components and each individual component, flow reversal time (min), radiation dose (GY/cm2), contrast volume utilized (mL), total procedure time (min), extended total length of stay (>1 day) and extended postoperative length of stay (>1 day). Statistical analyses employed both descriptive measures to characterize the study population and analytic measures such as multivariable mixed-effect linear and logistic regressions using both unmatched and propensity-score matched cohorts. Results A total of 2609 patients undergoing transcarotid artery revascularization between the years 2016 and 2018 in the US were identified, with 82.3% performed under general anesthesia and 17.7% under local anesthesia. The primary composite outcome was observed in 2.3% of general anesthesia patients versus 2.6% of local anesthesia patients ( p = 0.808). The rate of postoperative transient ischemic attack and/or myocardial infarction was 1.6% with general anesthesia versus 1.1% with local anesthesia ( p = 0.511). For adjusted regression analysis, general anesthesia and local anesthesia were comparable in terms of primary outcome (OR: 0.72; 95% CI: 0.27–1.93, p = 0.515). As for the secondary outcomes, no significant differences were found except for contrast, where the results demonstrated significantly less need for contrast with procedures performed under general anesthesia (coefficient: 4.94; 95% CI: 1.34–8.54, p = 0.007). A trend towards significance was observed for lower rate of postoperative transient ischemic attack and/or myocardial infarction (OR: 0.33; 95% CI: 0.09–1.18, p = 0.088) and lower flow reversal time under local anesthesia (coefficient: –0.94: 95% CI: –2.1–0.22, p = 0.111). Conclusions Excellent outcomes from transcarotid artery revascularization for carotid stenosis were observed in the VQI database between the years 2016 and 2018, under both local anesthesia and general anesthesia. The data demonstrate the choice of anesthesia for transcarotid artery revascularization does not appear to have any effect on clinical outcomes. Surgical teams should perform transcarotid artery revascularization under the anesthesia type they are most comfortable with.

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Section: Discussionmentioning

confidence: 99%

The study of transcarotid artery revascularization under local versus general anesthesia with results from the Society for Vascular Surgery Vascular Quality Initiative

et al. 2020

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“…Despite its use, clinical thrombosis is relatively rare having been described after deployment of drug eluting stents 37 . Notwithstanding, protamine has been described to significantly diminish the risk of bleeding complications without increasing the risk of clinical thrombosis in carotid artery procedures 38, 39 .…”

Section: Discussionmentioning

confidence: 99%

Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study

Larive

Feldman

et al. 2016

Journal of Vascular Surgery

107

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OBJECTIVES Early thrombosis (ET) contributes to autogenous arteriovenous fistula (AVF) failure. We studied patients undergoing AVF placement in the Hemodialysis Fistula Maturation (HFM) Study, a prospective, observational cohort study, using a nested case-control analysis to identify pre-operative and intra-operative predictors of ET. METHODS ET cases were compared to controls who were matched on gender, age, diabetes, dialysis status, and surgeon fistula volume. ET was defined as thrombosis diagnosed by physical exam or ultrasound within 18 days of AVF creation. Conditional logistic regression models were fit to identify risk factors for ET. RESULTS Thirty-two ET cases (5.3%) occurred among 602 study participants; 198 controls were matched. ET was associated with female gender (OR=2.75, CI 1.19–6.38, P=0.018), fistula location (forearm vs. upper arm) (OR=2.76, CI 1.05–7.23, P=0.039), feeding artery (radial vs. brachial) (OR=2.64, CI 1.03–6.77, P=0.043) and arterial diameter (OR=1.52, CI 1.02–2.26, P=0.039, per mm smaller). Draining vein diameter was nonlinearly associated with ET, with highest risk in 2–3 mm veins. Surprisingly, ET risk was lower in diabetics (OR=0.19, CI 0.07–0.47, P=0.0004), lower with less nitroglycerin-mediated brachial artery dilatation (NMD%) (OR=0.42, CI 0.20–1.92, P=0.029 for each 10% lower) and higher with lower carotid-femoral pulse wave velocity (OR=1.49, CI 1.02–2.20, P=0.041, for each m/sec lower). Intraoperative protamine use was associated with a higher ET risk (OR 3.26, CI 1.28-∞, P=0.038). Surgeon’s intraoperative perceptions were associated with ET: surgeons’ greater concern about maturation success (likely, marginal, unlikely) was associated with higher thrombosis risk (OR 8.09, CI 4.03-∞, p<0.0001, per category change), as were absence vs. presence of intraoperative thrill (OR 21.0, CI 5.07-∞, P=0.0002) and surgeons’ reported frustration during surgery (OR 6.85, CI 2.70-∞, P=0.0004). Reduced extent of intraoperative thrill (proximal, mid or distal third of the forearm or upper arm, based on AVF placement) was also associated with ET (OR 2.91, CI 1.31-∞, P=0.014, per diminished level). Oral antithrombotic medication use was not significantly associated with ET. CONCLUSIONS ET was found to be associated with female gender, forearm AVF, smaller arterial size, draining vein diameter of 2–3 mm, and protamine use. Paradoxically, diabetes and stiff, noncompliant feeding arteries were associated with lower frequency of ET. Absent or attenuated intraoperative thrill, and both surgeon frustration and concern about successful maturation during surgery, were strongly correlated with ET.

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“…We updated evidence from 2 systematic reviews that addressed this question, 198,199 identifying 3 RCTs [200][201][202] and 13 observational studies that measured relevant outcomes for patients receiving protamine for LMWH/UFH reversal when undergoing invasive procedures, not for major bleeding during VTE treatment. [203][204][205][206][207][208][209][210][211][212][213][214][215] Most studies did not specify whether "heparin" included UFH or LMWH; therefore, we could not analyze according to heparin subgroup. Given that only 74 patients receiving protamine were included in the RCTs, the panel elected to consider only the evidence from the observational studies.…”

Section: Recommendation 20mentioning

confidence: 99%

“…Six studies reported the effect of protamine administration on mortality, 205,206,209,210,212,214 10 studies reported development of major bleeding, 203,[205][206][207][208][209][211][212][213][214] 10 studies assessed the risk of stroke, [203][204][205][206][207][209][210][211]213,214 and 6 studies reported the risk of myocardial infarction. [205][206][207][212][213][214] No studies reported the risk of PE or DVT. The EtD framework is shown online at https://dbep.…”

Section: Recommendation 20mentioning

confidence: 99%

American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy

et al. 2018

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Background: Clinicians confront numerous practical issues in optimizing the use of anticoagulants to treat venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians and other health care professionals in their decisions about the use of anticoagulants in the management of VTE. These guidelines assume the choice of anticoagulant has already been made. Methods: ASH formed a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including updating or performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on 25 recommendations and 2 good practice statements to optimize management of patients receiving anticoagulants. Conclusions: Strong recommendations included using patient self-management of international normalized ratio (INR) with home point-of-care INR monitoring for vitamin K antagonist therapy and against using periprocedural low-molecular-weight heparin (LMWH) bridging therapy. Conditional recommendations included basing treatment dosing of LMWH on actual body weight, not using anti–factor Xa monitoring to guide LMWH dosing, using specialized anticoagulation management services, and resuming anticoagulation after episodes of life-threatening bleeding.

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Protamine Does Not Increase Risk of Stroke in Patients With Elective Carotid Stenting

Cited by 10 publications

References 15 publications

The study of transcarotid artery revascularization under local versus general anesthesia with results from the Society for Vascular Surgery Vascular Quality Initiative

The study of transcarotid artery revascularization under local versus general anesthesia with results from the Society for Vascular Surgery Vascular Quality Initiative

Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study

American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy

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