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Anesthesiology (all articles)

RCT: Low-Dose Ketamine Enhances Pain Relief When Added to Morphine in ED Patients

20 Nov, 2024 | 14:42h | UTC

Background: Acute pain is a prevalent complaint among emergency department (ED) patients, yet effective pain management remains suboptimal, especially in individuals with current opioid use due to opioid tolerance and hyperalgesia. Low-dose ketamine (LDK) has been proposed as an adjunct to opioids to enhance analgesia through synergistic or additive effects, but its efficacy in patients with and without current opioid use in the ED setting is not well established.

Objective: This randomized controlled trial aimed to determine the effectiveness of LDK as an adjunct to morphine versus morphine alone for acute pain management in ED patients with and without current opioid use.

Methods: In this single-center, double-blind study, 116 adult patients presenting to the ED with acute pain (numeric rating scale [NRS] ≥5) requiring intravenous opioids were randomized to receive either 0.1 mg/kg ketamine or isotonic saline (placebo) as an adjunct to morphine. Patients with and without current opioid use were randomized separately. Pain intensity was measured at baseline and at 10, 20, 30, 45, 60, and 120 minutes post-randomization. The primary outcome was pain reduction from baseline to 10 minutes. Secondary outcomes included pain intensity over 120 minutes, need for rescue opioids, side effects, and patient and provider satisfaction.

Results: The study included 116 patients (median age 51 years; 58% male; 36% with current opioid use). Pain reduction from baseline to 10 minutes was significantly greater in the LDK group compared to placebo (median reduction of 4 [IQR 3–6] vs. 1 [IQR 0–2]; p = 0.001). Pain intensity was significantly lower in the LDK group at 10, 20, and 30 minutes post-administration. There was a higher incidence of nausea, vomiting, and dissociation in the LDK group during the first 10 minutes. No significant differences were observed in the need for rescue opioids or in patient and provider satisfaction between groups.

Conclusions: LDK administered as an adjunct to morphine significantly enhances short-term pain relief in ED patients with acute pain, regardless of current opioid use status. However, the increased risk of transient side effects necessitates careful consideration.

Implications for Practice: LDK may be considered as an adjunct to morphine for acute pain management in the ED, particularly when traditional opioid treatments are insufficient. Clinicians should weigh the benefits against the potential for transient side effects, and LDK should not be universally recommended for all patients with moderate to severe pain.

Study Strengths and Limitations: Strengths of the study include its randomized, double-blind design and the inclusion of patients with current opioid use. Limitations include early termination leading to a smaller sample size, potentially underpowering the stratified analysis, and heterogeneity in patient pain conditions. Additionally, assessing the primary outcome at 10 minutes may not capture the peak effect of morphine.

Future Research: Further studies should focus on optimizing LDK administration protocols, such as exploring bolus versus continuous infusion methods, to achieve sustained pain reduction and minimize side effects.

Reference: Galili SF, et al. Low-dose ketamine as an adjunct to morphine: A randomized controlled trial among patients with and without current opioid use. Academic Emergency Medicine. 2024. DOI: http://doi.org/10.1111/acem.14983

 


Cohort Study: High Rate of Preventable Adverse Events in Surgical Inpatients

16 Nov, 2024 | 17:29h | UTC

Background: Adverse events during hospital admissions, particularly in surgical settings, remain a significant cause of patient harm despite efforts to improve patient safety since the “To Err is Human” report. Advances in surgical techniques and patient care necessitate an updated assessment of the current state of perioperative safety.

Objective: To estimate the frequency, severity, and preventability of adverse events associated with perioperative care in surgical inpatients and to identify the settings and healthcare professionals involved.

Methods: A multicenter retrospective cohort study was conducted across 11 US hospitals in Massachusetts. A weighted random sample of 1,009 patients was selected from 64,121 adults admitted for surgery in 2018. Trained nurses reviewed electronic health records to identify adverse events, which were then adjudicated by physicians. Adverse events were classified by type, severity, preventability, setting, and professions involved.

Results: Adverse events occurred in 38.0% of patients (95% CI, 32.6–43.4%), with major adverse events in 15.9% (12.7–19.0%). Among 593 adverse events identified, 59.5% were potentially preventable, and 20.7% were definitely or probably preventable. The most common events were surgery-related (49.3%), adverse drug events (26.6%), healthcare-associated infections (12.4%), and patient care events (11.2%). Adverse events most frequently occurred in general care units (48.8%) and involved attending physicians (89.5%) and nurses (58.9%).

Conclusions: More than one-third of surgical inpatients experienced adverse events, with nearly half classified as major and most potentially preventable. These findings highlight the critical need for ongoing improvement in patient safety throughout perioperative care involving all healthcare professionals.

Implications for Practice: Healthcare providers should enhance patient safety protocols across all perioperative settings, not just in operating rooms. Emphasis should be placed on preventing surgery-related complications, adverse drug events, and healthcare-associated infections by fostering teamwork and continuous monitoring.

Study Strengths and Limitations: Strengths include a comprehensive review of medical records and systematic classification of adverse events by trained professionals. Limitations involve the study’s confinement to Massachusetts hospitals in 2018, potential variability in documentation practices, and limited sample size affecting generalizability and specialty-specific estimates.

Future Research: Further studies are needed to assess adverse event rates in diverse geographic locations and healthcare systems, explore effective interventions to reduce preventable harm, and evaluate long-term trends in surgical patient safety.

Reference: Duclos A, Frits ML, Iannaccone C, Lipsitz SR, Cooper Z, Weissman JS, Bates DW. Safety of inpatient care in surgical settings: cohort study. BMJ. 2024; DOI: http://doi.org/10.1136/bmj-2024-080480

 


Retrospective Cohort Study: Midline Catheters Associated with Lower Major Complications Than PICCs in Outpatient Antimicrobial Therapy

16 Nov, 2024 | 14:35h | UTC

Background: Outpatient parenteral antimicrobial therapy (OPAT) requires reliable vascular access for administering intravenous antibiotics post-hospitalization. Peripherally inserted central catheters (PICCs) are commonly used due to their versatility and ease of placement. Recently, midline catheters have emerged as potential alternatives for OPAT, offering less invasive access. However, limited evidence exists comparing the safety and complication rates of midline catheters versus PICCs in OPAT patients.

Objective: To compare the risk of major and minor device complications associated with midline catheters versus PICCs in patients receiving OPAT.

Methods: This retrospective cohort study analyzed data from 2,824 hospitalized patients across 69 Michigan hospitals who received either a midline catheter (n=1,999) or a PICC (n=825) for OPAT between January 2017 and November 2023. Patients receiving vancomycin were excluded. The primary outcome was major device complications, defined as catheter-related bloodstream infection (CRBSI) or catheter-related venous thromboembolism (CR-VTE). Secondary outcomes included minor device complications (e.g., catheter dislodgement, occlusion) and device failure, defined as catheter removal due to any complication.

Results: Midline catheters were associated with a lower risk of major complications compared to PICCs (0.8% vs 3.4%; adjusted hazard ratio [aHR], 0.46; 95% CI, 0.23-0.91; P < .001). This difference was more pronounced for devices with dwell times of 14 days or fewer (aHR, 0.29; 95% CI, 0.12-0.68). There were no significant differences in minor complications (10.3% vs 13.8%; aHR, 1.07; 95% CI, 0.83-1.38) or device failure rates (9.6% vs 12.1%; aHR, 1.26; 95% CI, 0.96-1.65) between midline catheters and PICCs.

Conclusions: Midline catheters are associated with a lower risk of major complications compared to PICCs in patients receiving OPAT, particularly for treatment durations of 14 days or fewer. These findings suggest that midline catheters are a safe and effective alternative to PICCs for short-term OPAT.

Implications for Practice: Clinicians should consider using midline catheters for OPAT when the anticipated therapy duration is 14 days or less and the infusate is peripherally compatible. This may reduce the risk of major complications such as CRBSI and CR-VTE, potentially improving patient outcomes and reducing healthcare costs.

Study Strengths and Limitations: Strengths of this study include a large, diverse patient population across multiple hospitals and rigorous data collection methods. Limitations include its retrospective design, potential for unmeasured confounding, and exclusion of patients receiving vancomycin, which may limit generalizability. Additionally, complications occurring after 30 days or post-device removal may have been missed.

Future Research: Further studies are needed to evaluate the safety and efficacy of midline catheters for OPAT durations exceeding 14 days and to explore factors influencing long-term device performance and patient outcomes.

Reference: Paje D, et al. Midline vs Peripherally Inserted Central Catheter for Outpatient Parenteral Antimicrobial Therapy. JAMA Internal Medicine. 2024. DOI: http://doi.org/10.1001/jamainternmed.2024.5984

 


Multisociety Guidelines for Perioperative Management of GLP-1 Receptor Agonists

3 Nov, 2024 | 14:27h | UTC

Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have transformed the management of metabolic diseases such as type 2 diabetes, obesity, and heart failure by enhancing glycemic control and promoting satiety. However, their effect of delaying gastric emptying has raised perioperative safety concerns due to the risk of residual gastric contents leading to pulmonary aspiration during anesthesia. Reports of aspiration incidents and gastrointestinal side effects like nausea and vomiting have prompted the need for unified clinical guidance. This multisociety clinical practice guideline aims to provide recommendations for safely managing patients on GLP-1RAs during the perioperative period, balancing metabolic benefits with procedural risks.

Key Recommendations:

  1. Shared Decision-Making:
    • Collaborative Approach: The continuation or discontinuation of GLP-1RAs should involve shared decision-making among the patient, surgical team, anesthesia providers, and prescribing clinicians.
    • Risk Assessment: Evaluate factors that elevate the risk of delayed gastric emptying and aspiration, including:
      • Dose Escalation Phase: Higher risk during dose escalation compared to maintenance.
      • Higher Dosage: Increased gastrointestinal side effects with higher doses.
      • Weekly Formulations: Greater side effects with weekly dosing compared to daily formulations.
      • Gastrointestinal Symptoms: Presence of nausea, vomiting, abdominal pain, dyspepsia, or constipation.
      • Comorbid Conditions: Conditions like gastroparesis, bowel dysmotility, or neurological disorders affecting gastric motility.
    • Timing: Conduct risk assessments well in advance of surgery to allow for appropriate preoperative planning.
  2. Management of GLP-1RA Therapy:
    • Continuation in Low-Risk Patients: GLP-1RAs may be continued preoperatively in patients without elevated risk factors.
    • Balancing Risks in High-Risk Patients:
      • Metabolic vs. Procedural Risks: Weigh the risks of aspiration against potential metabolic complications like hyperglycemia if GLP-1RAs are withheld.
      • Avoiding Bias: Decisions should not be based solely on obesity status to prevent bias.
    • Discontinuation Guidelines:
      • Daily Formulations: Hold on the day of surgery.
      • Weekly Formulations: Discontinue one week prior to surgery.
    • Day-of-Surgery Assessment: All patients should be evaluated for symptoms of delayed gastric emptying on the day of the procedure, regardless of GLP-1RA usage.
  3. Minimizing Aspiration Risk:
    • Preoperative Dietary Modifications:
      • Liquid Diet: Implement a liquid diet for at least 24 hours before surgery, similar to protocols for colonoscopy and bariatric procedures.
    • Gastric Content Assessment:
      • Point-of-Care Ultrasound: Use gastric ultrasound to assess residual gastric contents when there is concern for delayed emptying, acknowledging potential limitations in resources and expertise.
    • Anesthesia Plan Adjustments:
      • Rapid Sequence Induction: Consider rapid sequence induction with tracheal intubation to minimize aspiration risk in patients with confirmed or suspected delayed gastric emptying.
      • Procedure Continuation vs. Cancellation: Engage in shared decision-making to weigh the benefits of proceeding with the procedure against the risks, aiming to avoid unnecessary cancellations.

Conclusion: By adopting these recommendations, healthcare providers can enhance patient safety during the perioperative period for those receiving GLP-1RA therapy. The guidelines emphasize individualized care through shared decision-making, considering both metabolic benefits and procedural risks. Implementing these practices is expected to reduce aspiration incidents, optimize surgical outcomes, and ensure equitable care without bias against patients with obesity or metabolic disorders. As new evidence and medications emerge, these guidelines may be updated to reflect best practices.

Reference: Kindel TL, Wang AY, Wadhwa A, et al. Multisociety clinical practice guidance for the safe use of glucagon-like peptide-1 receptor agonists in the perioperative period. Surgery for Obesity and Related Diseases. 2024; In Press. https://doi.org/10.1016/j.soard.2024.08.033

 


RCT: More Frequent Screening with Pressure-Supported SBTs Delayed Extubation in Mechanically Ventilated Adults

13 Oct, 2024 | 13:15h | UTC

Background: Prompt liberation from mechanical ventilation is crucial to reduce complications associated with prolonged ventilator use. The optimal frequency of weaning readiness screening and the most effective spontaneous breathing trial (SBT) technique are not well established.

Objective: To evaluate whether the frequency of screening for weaning readiness (once-daily vs more frequent) and the SBT technique used (pressure-supported vs T-piece) affect the time to successful extubation in adults receiving invasive mechanical ventilation.

Methods: In a multicenter randomized clinical trial with a 2×2 factorial design, 797 critically ill adults who had been mechanically ventilated for at least 24 hours were enrolled. Participants were randomized to either once-daily or more frequent screening for weaning readiness and to undergo either pressure-supported SBTs (pressure support >0 to ≤8 cm H₂O with PEEP >0 to ≤5 cm H₂O) or T-piece SBTs, each lasting 30–120 minutes. The primary outcome was the time to successful extubation, defined as the time from starting unsupported spontaneous breathing that was sustained for at least 48 hours post-extubation.

Results: Among the 797 patients (mean age 62.4 years; 59.2% male), there was no significant difference in time to successful extubation when comparing screening frequencies (hazard ratio [HR] 0.88; 95% CI, 0.76–1.03; P = .12) or SBT techniques (HR 1.06; 95% CI, 0.91–1.23; P = .45) individually. However, a significant interaction between screening frequency and SBT technique was identified (P = .009). Specifically, in patients undergoing pressure-supported SBTs, more frequent screening *delayed* time to successful extubation compared to once-daily screening (HR 0.70; 95% CI, 0.50–0.96; P = .02). Conversely, when T-piece SBTs were used, the frequency of screening did not significantly affect extubation time. The median time to successful extubation was shortest in the once-daily screening with pressure-supported SBT group (2.0 days) and longest in the more frequent screening with pressure-supported SBT group (3.9 days).

Conclusions: More frequent screening combined with pressure-supported SBTs resulted in a *longer* time to successful extubation, suggesting this combination may delay weaning from mechanical ventilation. Once-daily screening with pressure-supported SBTs showed a trend toward faster extubation compared to other strategies, although this was not statistically significant.

Implications for Practice: Clinicians should be cautious about combining more frequent screening with pressure-supported SBTs, as this may unintentionally prolong mechanical ventilation. Adopting once-daily screening with pressure-supported SBTs might facilitate earlier extubation.

Study Strengths and Limitations: Strengths of the study include its large sample size, multicenter design, and high adherence to the intervention protocols. Limitations involve the unexpected significant interaction between interventions, which may limit the generalizability of the results.

Future Research: Additional studies are warranted to confirm the interaction between screening frequency and SBT technique and to explore the mechanisms underlying the delayed extubation with more frequent screening and pressure-supported SBTs.

Reference: Burns KEA, et al (2024). Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial. JAMA. DOI: http://doi.org/10.1001/jama.2024.20631

 


RCT: Liberal Transfusion Strategy Reduced Unfavorable Neurological Outcomes in Acute Brain Injury

12 Oct, 2024 | 11:01h | UTC

Background: Patients with acute brain injury frequently develop anemia, and the optimal hemoglobin threshold for red blood cell transfusion in this population remains uncertain. Previous studies have shown conflicting results regarding the benefits of liberal versus restrictive transfusion strategies on neurological outcomes.

Objective: To determine whether a liberal transfusion strategy (hemoglobin threshold <9 g/dL) reduces the occurrence of unfavorable neurological outcomes at 180 days compared to a restrictive strategy (hemoglobin threshold <7 g/dL) in patients with acute brain injury.

Methods: The TRAIN trial, a multicenter, phase 3, randomized clinical trial, was conducted across 72 ICUs in 22 countries. It included patients with traumatic brain injury, aneurysmal subarachnoid hemorrhage, or intracerebral hemorrhage, who had hemoglobin levels below 9 g/dL within the first 10 days post-injury. Participants were randomized to a liberal strategy (transfusion triggered by hemoglobin <9 g/dL) or a restrictive strategy (transfusion triggered by hemoglobin <7 g/dL), with primary outcomes measured by the occurrence of an unfavorable neurological outcome, defined by a Glasgow Outcome Scale Extended score of 1-5 at 180 days.

Results: Among 820 patients who completed the trial (mean age 51 years; 45.9% women), 806 had data on the primary outcome (393 liberal, 413 restrictive). The liberal group received a median of 2 units of blood (IQR, 1–3), while the restrictive group received a median of 0 units (IQR, 0–1), with an absolute mean difference of 1.0 unit (95% CI, 0.87–1.12 units). At 180 days, 62.6% of patients in the liberal group had an unfavorable neurological outcome compared to 72.6% in the restrictive group (absolute difference –10.0%; 95% CI, –16.5% to –3.6%; adjusted relative risk 0.86; P = .002). The effect was consistent across prespecified subgroups. Cerebral ischemic events were lower in the liberal group (8.8% vs 13.5%; relative risk 0.65; 95% CI, 0.44–0.97). No significant differences were observed in 28-day survival or other secondary outcomes.

Conclusions: In patients with acute brain injury and anemia, a liberal transfusion strategy resulted in a lower rate of unfavorable neurological outcomes at 180 days compared to a restrictive strategy.

Implications for Practice: A liberal transfusion threshold of 9 g/dL may improve neurological outcomes in patients with acute brain injury by reducing cerebral ischemic events. Clinicians should consider adopting a higher hemoglobin threshold for transfusion in this population, weighing the benefits against potential risks associated with transfusions, such as infection or lung injury.

Study Strengths and Limitations: Strengths include the large, multicenter international design and blinding of outcome assessors. Limitations involve the open-label nature, potential detection bias in assessing cerebral ischemic events, lack of standardized neuroprognostication, and incomplete assessment of concomitant interventions.

Future Research: Further studies are needed to confirm these findings in specific subgroups of acute brain injury, to explore optimal transfusion strategies, and to assess long-term outcomes and potential risks associated with liberal transfusion thresholds.

Reference: Taccone FS, et al. (2024) Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial. JAMA. DOI: http://doi.org/10.1001/jama.2024.20424

 


Summary of the review “Neuroleptic Malignant Syndrome”

6 Oct, 2024 | 16:20h | UTC

In a comprehensive review published in the New England Journal of Medicine, Wijdicks and Ropper discuss neuroleptic malignant syndrome (NMS), a rare but potentially fatal complication of antipsychotic therapy characterized by fever, muscle rigidity, and autonomic dysfunction. Given the widespread use of dopamine-blocking agents across various medical specialties, it is crucial for practicing physicians to recognize and manage this syndrome promptly to improve patient outcomes.

Key Aspects Influencing Patient Care:

  • Epidemiology and Risk Factors:
    • NMS occurs in approximately 0.02 to 3% of patients exposed to dopamine-blocking agents.
    • Risk factors include dehydration, high doses of antipsychotics, rapid dose escalation, intramuscular administration, and prior episodes of NMS.
    • Both first-generation (typical) and second-generation (atypical) antipsychotics can cause NMS, though it may be less severe with atypical agents.
  • Clinical Presentation:
    • Hyperthermia: Elevated temperatures often exceeding 40°C.
    • Muscle Rigidity: Lead-pipe rigidity leading to rhabdomyolysis and elevated creatine kinase levels.
    • Autonomic Dysfunction: Tachycardia, fluctuating blood pressure, diaphoresis.
    • Altered Mental Status: Ranges from agitation to stupor or catatonia.
    • Laboratory Findings: Leukocytosis, electrolyte imbalances, and signs of renal impairment.
  • Diagnosis:
    • Based on clinical criteria including recent exposure to dopamine antagonists and presence of key symptoms.
    • Important to differentiate from serotonin syndrome, malignant hyperthermia, heat stroke, and severe catatonia.
  • Management:
    • Immediate Discontinuation of the offending agent.
    • Supportive Care in ICU:
      • Stabilize vital signs and manage autonomic instability.
      • Aggressive hydration to prevent renal failure from rhabdomyolysis.
      • Cooling measures for hyperthermia.
    • Pharmacologic Interventions:
      • Dantrolene: Reduces muscle rigidity and hyperthermia.
      • Dopamine Agonists: Bromocriptine or amantadine may reverse dopamine blockade.
      • Benzodiazepines: Lorazepam for sedation and muscle relaxation.
    • Monitoring for Complications:
      • Watch for respiratory failure, renal dysfunction, electrolyte disturbances, and cardiac arrhythmias.
    • Electroconvulsive Therapy (ECT):
      • Considered in refractory cases unresponsive to medical management.
  • Outcome and Prognosis:
    • Recovery typically occurs within 7 to 11 days with appropriate treatment.
    • Mortality rates have decreased but can reach up to 15% within one year due to complications.
    • Rechallenge with Antipsychotics:
      • If necessary, reintroduce antipsychotics cautiously after full recovery, using low doses and slow titration.
      • Prefer atypical agents and monitor closely for recurrence.

Clinical Implications:

  • Early Recognition: Timely identification of NMS is critical for initiating life-saving interventions.
  • Interdisciplinary Approach: Collaboration among psychiatrists, intensivists, neurologists, and other specialists enhances patient care.
  • Education and Prevention:
    • Educate healthcare providers about the signs and risk factors of NMS.
    • Monitor patients on antipsychotics closely, especially during dose changes or when using high-potency agents.

Reference: Wijdicks, E. F. M., & Ropper, A. H. (2024). Neuroleptic Malignant Syndrome. New England Journal of Medicine, 391(12), 1130–1138. DOI: 10.1056/NEJMra2404606

 


Summary: Perioperative Management of Patients Taking Direct Oral Anticoagulants

19 Sep, 2024 | 21:12h | UTC

Direct oral anticoagulants (DOACs)—including apixaban, rivaroxaban, edoxaban, and dabigatran—are increasingly used for stroke prevention in atrial fibrillation and for treating venous thromboembolism. Effective perioperative management of DOACs is essential to minimize bleeding and thromboembolic risks during surgical and nonsurgical procedures. Below are practical recommendations focused on the perioperative management of patients taking DOACs, based on a recent JAMA review article.


Elective Surgical or Nonsurgical Procedures

Classify Bleeding Risk of Procedures:

  1. Minimal Risk:
    • Minor dental procedures (e.g., cleaning, extractions)
    • Minor dermatologic procedures (e.g., skin lesion removal)
    • Cataract surgery
  2. Low to Moderate Risk:
    • Endoscopic procedures without high-risk interventions
    • Cholecystectomy
    • Inguinal hernia repair
  3. High Risk:
    • Major surgery (e.g., cancer surgery, joint replacement)
    • Procedures involving neuraxial anesthesia
    • Endoscopic procedures with high-risk interventions (e.g., large polyp removal)

DOAC Management Strategies:

  1. Minimal Bleeding Risk Procedures:
    • Option 1: Continue DOACs without interruption.
    • Option 2: For added safety, withhold the morning dose on the day of the procedure (especially for twice-daily DOACs like apixaban and dabigatran).
  2. Low to Moderate Bleeding Risk Procedures:
    • Preoperative:
      • Discontinue DOACs 1 day before the procedure.
      • This allows approximately 2 half-lives for drug clearance.
    • Postoperative:
      • Resume DOACs 1 day after the procedure, ensuring adequate hemostasis.
  3. High Bleeding Risk Procedures:
    • Preoperative:
      • Discontinue DOACs 2 days before the procedure.
      • This allows approximately 4-5 half-lives for drug clearance.
    • Postoperative:
      • Resume DOACs 2-3 days after the procedure, based on bleeding risk and hemostasis.

Evidence Supporting These Strategies:

  • The PAUSE study demonstrated that standardized interruption protocols without heparin bridging result in low rates of:
    • Thromboembolism: 0.2%–0.4%
    • Major Bleeding: 1%–2%

Postoperative DOAC Resumption:

  • Assess surgical-site hemostasis before resuming DOACs.
  • Delay resumption if there is ongoing bleeding or concerns about hemostasis.
  • For high bleeding risk procedures, consider a longer delay (2–3 days).

Perioperative Heparin Bridging:

  • Not recommended for patients on DOACs.
  • Bridging increases bleeding risk without reducing thromboembolism.
  • DOACs have rapid offset and onset, making bridging unnecessary.

Special Considerations

Patients with Impaired Renal Function:

  • For CrCl 30–50 mL/min:
    • Dabigatran: Extend preoperative discontinuation by an additional day.
  • For CrCl <30 mL/min:
    • Dabigatran is contraindicated.
    • For other DOACs, consider extending discontinuation to 3–4 days before surgery.

Patients Undergoing Neuraxial Anesthesia:

  • Discontinue DOACs for 3 days (apixaban, edoxaban, rivaroxaban) or 4 days (dabigatran) before the procedure.
  • Minimizes risk of spinal or epidural hematoma.

Dental Procedures:

  • Generally safe to continue DOACs.
  • For added safety:
    • Omit or delay the dose on the day of the procedure.
    • Employ local hemostatic measures (e.g., tranexamic acid mouthwash).

Endoscopic Procedures:

  • Low-risk procedures (e.g., diagnostic endoscopy without biopsy):
    • Follow standard DOAC interruption for low to moderate bleeding risk.
  • High-risk procedures (e.g., polypectomy of large polyps):
    • Extend DOAC discontinuation by an additional day pre- and post-procedure.

Patients Unable to Resume Oral Medications Postoperatively:

  • Use prophylactic low-molecular-weight heparin (LMWH) until oral intake is possible.
  • Avoid therapeutic-dose LMWH due to bleeding risk.

Emergent, Urgent, or Semiurgent Procedures

Risks:

  • Higher bleeding risk: Up to 23%
  • Thromboembolism risk: Up to 11%

Management Strategies:

  1. Assess Time Since Last DOAC Dose:
    • If within 48 hours, consider that significant anticoagulant effect may persist.
  2. Laboratory Testing (if available):
    • DOAC Level Testing:
      • ≥50 ng/mL: Consider using reversal agents.
      • <50 ng/mL: May proceed without reversal agents.
  3. Use of Reversal Agents:
    • For Dabigatran:
      • Idarucizumab (5 g IV)
    • For Factor Xa Inhibitors (apixaban, rivaroxaban, edoxaban):
      • Andexanet alfa (dosing based on last dose timing and amount)
      • Prothrombin Complex Concentrates (PCCs): If andexanet alfa is unavailable or contraindicated.
  4. Proceeding Without Testing:
    • If testing is unavailable and last DOAC dose was within 48 hours, consider reversal agents.
    • If >48 hours since last dose, may proceed without reversal.

Considerations:

  • Reversal agents are expensive and may carry thrombotic risks.
  • Use should be judicious, weighing risks and benefits.
  • Consult hematology or thrombosis experts when possible.

Key Takeaways

  • Elective Procedures:
    • Utilize standardized protocols based on procedural bleeding risk.
    • Routine preoperative DOAC level testing is unnecessary.
    • Avoid heparin bridging.
  • Emergent/Urgent Procedures:
    • Reversal agents may be appropriate when significant DOAC levels are present.
    • Decision to use reversal agents should consider bleeding risk, time since last dose, and availability of DOAC level testing.
  • Patient Communication:
    • Ensure patients understand the plan for DOAC interruption and resumption.
    • Provide clear instructions regarding timing and dosing.
  • Interdisciplinary Coordination:
    • Collaborate with surgical teams, anesthesiologists, and pharmacists.
    • Use electronic medical records and clinical decision support tools to enhance communication.

Conclusion

By applying standardized perioperative management protocols, clinicians can effectively balance the risks of bleeding and thromboembolism in patients taking DOACs who require surgical or nonsurgical procedures. These strategies simplify decision-making, avoid unnecessary interventions like heparin bridging, and promote patient safety.

Reference: Douketis JDSpyropoulos AC. Perioperative Management of Patients Taking Direct Oral AnticoagulantsA ReviewJAMA. 2024;332(10):825–834. doi:10.1001/jama.2024.12708

 


RCT: Preoxygenation with Noninvasive Ventilation Reduced Hypoxemia during Emergency Intubation

19 Sep, 2024 | 12:53h | UTC

Background: Hypoxemia during tracheal intubation in critically ill adults increases the risk of cardiac arrest and death. Preoxygenation aims to mitigate this risk, but the optimal method remains uncertain. Noninvasive ventilation (NIV) may offer advantages over oxygen masks by providing positive pressure and higher inspired oxygen fractions, but evidence is limited.

Objective: To determine whether preoxygenation with noninvasive ventilation reduces the incidence of hypoxemia during tracheal intubation compared to preoxygenation with an oxygen mask among critically ill adults.

Methods: In a multicenter, pragmatic, unblinded, randomized trial conducted at 24 emergency departments and intensive care units in the United States, 1301 critically ill adults (age ≥18 years) undergoing tracheal intubation were randomized 1:1 to receive preoxygenation with either noninvasive ventilation (n=645) or an oxygen mask (n=656). Patients already receiving positive-pressure ventilation or at high risk of aspiration were excluded. In the NIV group, preoxygenation was administered using a tight-fitting mask connected to a ventilator, with an FiO₂ of 100%, expiratory pressure ≥5 cm H₂O, and inspiratory pressure ≥10 cm H₂O. In the oxygen-mask group, preoxygenation was provided using a nonrebreather mask or bag-mask device without manual ventilation, with oxygen flow ≥15 liters per minute. The primary outcome was hypoxemia during intubation, defined as oxygen saturation <85% between induction of anesthesia and 2 minutes after tracheal intubation.

Results: Hypoxemia occurred in 9.1% of patients in the NIV group versus 18.5% in the oxygen-mask group (difference –9.4 percentage points; 95% CI, –13.2 to –5.6; P<0.001). Cardiac arrest during intubation occurred in 0.2% of patients in the NIV group and 1.1% in the oxygen-mask group (difference –0.9 percentage points; 95% CI, –1.8 to –0.1). Aspiration occurred in 0.9% of patients in the NIV group and 1.4% in the oxygen-mask group (difference –0.4 percentage points; 95% CI, –1.6 to 0.7). No significant differences were observed in other adverse events.

Conclusions: Preoxygenation with noninvasive ventilation significantly reduced the incidence of hypoxemia during tracheal intubation among critically ill adults compared to preoxygenation with an oxygen mask, without increasing the risk of aspiration.

Implications for Practice: Preoxygenation with noninvasive ventilation should be considered for critically ill adults undergoing emergency tracheal intubation to reduce the risk of hypoxemia and potential cardiac arrest. Clinicians should ensure appropriate equipment and training are available for the use of NIV during preoxygenation.

Study Strengths and Limitations: Strengths include a large sample size, multicenter design across diverse emergency departments and ICUs, and pragmatic approach enhancing generalizability. Limitations include exclusion of patients already receiving positive-pressure ventilation or at high risk of aspiration, potentially limiting applicability to these populations. The unblinded design may introduce bias, although outcome data were collected by independent observers.

Future Research: Further studies are needed to evaluate the effectiveness of noninvasive ventilation for preoxygenation in patients at high risk of aspiration and to compare its efficacy with high-flow nasal cannula. Research should also assess long-term clinical outcomes and cost-effectiveness of implementing NIV for preoxygenation.

Reference: Gibbs K.W., et al. (2024) Noninvasive Ventilation for Preoxygenation during Emergency Intubation. New England Journal of Medicine. DOI: http://doi.org/10.1056/NEJMoa2313680

 


Meta-analysis: Perioperative Colchicine Reduced Postoperative Atrial Fibrillation After CABG

18 Sep, 2024 | 13:33h | UTC

Background: Coronary artery disease (CAD) remains a leading cause of mortality worldwide. Inflammation is a key factor in the development and progression of CAD, and anti-inflammatory therapies have shown potential in improving cardiovascular outcomes. Colchicine, traditionally used to treat gout, has demonstrated efficacy in reducing cardiovascular events in patients with chronic CAD. Previous individual studies have suggested that perioperative colchicine may decrease the incidence of postoperative atrial fibrillation (POAF) in patients undergoing coronary artery bypass grafting (CABG), but a comprehensive analysis is needed to confirm these findings.

Objective: To evaluate the effect of perioperative colchicine administration on the incidence of POAF in patients undergoing isolated CABG surgery through a meta-analysis of randomized controlled trials (RCTs).

Methods: A systematic search was conducted across MEDLINE, Web of Science, and The Cochrane Library to identify RCTs comparing perioperative colchicine administration with standard care in patients undergoing CABG. Inclusion criteria encompassed studies involving isolated CABG patients randomized to receive colchicine or standard care without colchicine. The primary outcome was the incidence of POAF during short-term follow-up.

Results: Five RCTs published between 2014 and 2022 met the inclusion criteria, including a total of 839 patients undergoing isolated CABG. Perioperative colchicine administration was associated with a significant reduction in POAF rates compared to standard care (relative risk [RR], 0.54; 95% confidence interval [CI], 0.40–0.73; p < 0.01). Other outcomes, such as graft patency, myocardial infarction, or long-term mortality, were not uniformly reported and, therefore, not analyzed.

Conclusions: Perioperative administration of colchicine is associated with a significant reduction in the incidence of POAF in patients undergoing CABG surgery.

Implications for Practice: Colchicine may be considered as a prophylactic strategy to reduce POAF in patients undergoing CABG, potentially improving both short- and long-term outcomes. Given the association of POAF with increased perioperative morbidity and long-term adverse events, implementing colchicine could have substantial clinical benefits in this high-risk population.

Study Strengths and Limitations: Strengths of this meta-analysis include the exclusive inclusion of randomized controlled trials and the use of rigorous statistical methods, including sensitivity analysis, which confirmed the robustness of the results. Limitations involve the small number of studies (five RCTs), potential variability in colchicine dosing regimens, and the lack of data on other clinically relevant outcomes.

Future Research: Large-scale, multicenter RCTs are warranted to further assess the effects of colchicine on other important outcomes in CABG patients, such as graft patency, myocardial infarction rates, and long-term mortality. Future studies should also evaluate the risk-benefit profile of colchicine in this patient population to establish its full role in clinical practice.

Reference: Kirov H., Caldonazo T., Runkel A., et al. (2024). Colchicine in Patients with Coronary Disease Undergoing Coronary Artery Bypass Surgery – A Meta-Analysis of Randomized Controlled Trials. The American Journal of Cardiology. DOI: http://doi.org/10.1016/j.amjcard.2024.09.003

 


RCT: Interruption of Oral Anticoagulation during TAVI Reduces Bleeding Without Increasing Thromboembolic Events

7 Sep, 2024 | 12:43h | UTC

Study Design and Population: This international, open-label, randomized noninferiority trial examined 858 patients undergoing transcatheter aortic-valve implantation (TAVI) who had an indication for oral anticoagulation due to concomitant diseases. Patients were randomized 1:1 to either continue or interrupt their oral anticoagulation during the procedure, with the primary outcome being a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days.

Main Findings: Primary outcome events occurred in 16.5% of the continuation group and 14.8% of the interruption group, showing a non-significant risk difference of 1.7 percentage points (95% CI, -3.1 to 6.6). Thromboembolic events were similar between groups (8.8% in continuation vs. 8.2% in interruption). However, bleeding events were significantly higher in the continuation group (31.1% vs. 21.3%; risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).

Implications for Practice: Interrupting oral anticoagulation during TAVI significantly reduces bleeding without increasing thromboembolic risks, suggesting it may be a safer strategy for patients undergoing TAVI. These findings could influence clinical decision-making regarding anticoagulation management in this population.

Reference: van Ginkel, D.J. et al. (2024). Continuation versus Interruption of Oral Anticoagulation during TAVI. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2407794

 


RCT: Continuing Aspirin vs. Antiplatelet Cessation Before Surgery Did Not Reduce Ischemic Events in Patients With Coronary Stents Over 1 Year Post-Implantation

7 Sep, 2024 | 12:29h | UTC

Study Design and Population: This randomized controlled trial (ASSURE-DES) investigated the perioperative management of antiplatelet therapy in 926 patients with coronary drug-eluting stents (DES) undergoing low-to-intermediate-risk noncardiac surgery. The patients, at least one year post-stent implantation, were randomized to continue aspirin monotherapy or stop all antiplatelet therapy five days prior to surgery.

Main Findings: The study found no significant difference in the primary composite outcome (death, myocardial infarction, stent thrombosis, or stroke) between the aspirin monotherapy group (0.6%) and the no antiplatelet group (0.9%). However, minor bleeding was more frequent in the aspirin group (14.9% vs 10.1%, P=0.027), with no difference in major bleeding.

Implications for Practice: These results suggest that for stable patients with DES undergoing noncardiac surgery, temporarily discontinuing aspirin may be a safe option, as continuing aspirin did not reduce ischemic events but did increase minor bleeding risk. Further research is needed to assess outcomes in higher-risk surgical settings.

Reference: Kang, D.-Y. et al. (2024). Aspirin monotherapy vs no antiplatelet therapy in stable patients with coronary stents undergoing low-to-intermediate risk noncardiac surgery. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2024.08.024

 


News Release: SCOFF Trial Confirms Fasting Not Necessary Before Cardiac Catheterisation Procedures

7 Sep, 2024 | 10:10h | UTC

1 September 2024 – London, United Kingdom – New findings from the SCOFF trial, presented at ESC Congress 2024, suggest that fasting prior to minimally invasive cardiac catheterisation procedures under conscious sedation does not increase the risk of complications. The trial supports reconsidering current guidelines on pre-procedural fasting.

Key Points for Physicians:

– No increased complications: The SCOFF trial found no significant difference in adverse outcomes, such as aspiration pneumonia or hypoglycemia, between patients who fasted and those who ate normally before cardiac catheterisation.

– Improved patient satisfaction: Patients who did not fast reported higher satisfaction, with fewer complaints of discomfort and hunger.

– Potential guideline change: These findings, in line with previous studies like CHOW-NOW and TONIC, challenge the necessity of fasting before such procedures.

The trial’s lead investigator, Dr. David Ferreira (John Hunter Hospital, Australia), emphasized that avoiding fasting may improve patient experience without increasing risks, making it time to reconsider fasting guidelines for these procedures.

Study Overview:

– Trial design: Prospective, randomized, open-label, with blinded endpoint assessment.

– Participants: 716 patients undergoing coronary angiography, coronary intervention, or cardiac implantable electronic device procedures.

– Primary endpoint: Composite of hypotension, aspiration pneumonia, hyperglycemia, and hypoglycemia, showing a lower event rate in the non-fasting group (12.0%) compared to the fasting group (19.1%).

These results are likely to influence future clinical practice, providing greater flexibility for both patients and healthcare systems.

Source: https://www.escardio.org/The-ESC/Press-Office/Press-releases/SCOFF-trial-confirms-that-fasting-is-not-needed-before-cath-lab-procedures

 


RCT: No Difference in Postoperative Complications Between Continuation and Discontinuation of Renin-Angiotensin System Inhibitors Before Major Surgery – JAMA

31 Aug, 2024 | 19:12h | UTC

Study Design and Population: This multicenter randomized clinical trial included 2,222 patients who had been treated with renin-angiotensin system inhibitors (RASIs) for at least 3 months and were scheduled for major noncardiac surgery at 40 hospitals in France between January 2018 and April 2023. The participants were randomly assigned to either continue RASIs until the day of surgery or to discontinue them 48 hours before surgery.

Main Findings: The trial found no significant difference in the primary outcome—a composite of all-cause mortality and major postoperative complications within 28 days—between the continuation and discontinuation groups (22% in both groups, RR 1.02, 95% CI 0.87-1.19). However, the continuation group experienced a higher incidence of intraoperative hypotension (54% vs. 41%, RR 1.31, 95% CI 1.19-1.44).

Implications for Practice: Continuation of RASIs before major noncardiac surgery does not increase the risk of postoperative mortality or major complications, but it does elevate the risk of intraoperative hypotension. Clinicians should weigh these risks when deciding whether to continue or discontinue RASIs before surgery.

Reference: Legrand M, Falcone J, Cholley B, et al. (2024). Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial. JAMA. https://doi.org/10.1001/jama.2024.17123

 


Meta-Analysis: ERAS Protocols Improve Recovery and Reduce Complications After Emergency Laparotomy – Am J Surg

18 Aug, 2024 | 19:32h | UTC

Study Design and Population: This systematic review and meta-analysis assessed the effects of Enhanced Recovery After Surgery (ERAS) protocols compared to standard care (SC) in patients undergoing emergency laparotomy. The analysis included six randomized clinical trials (RCTs) with a total of 509 patients.

Main Findings: The ERAS group showed a reduction in length of hospital stay (mean difference: -2.92 days) and quicker recovery milestones, such as time to ambulation (mean difference: -1.67 days) and first bowel opening (mean difference: -1.26 days). The ERAS protocols were also associated with lower rates of pulmonary complications (odds ratio [OR]: 0.43) and surgical site infections (OR: 0.33). Mortality rates were similar between the ERAS and SC groups.

Implications for Practice: These findings suggest that ERAS protocols may enhance recovery and reduce complications in patients undergoing emergency laparotomy. Implementation of these protocols could be beneficial in emergency surgical settings, where feasible.

Reference: Amir AH, Davey MG, Donlon NE. (2024). Evaluating the Impact of Enhanced Recovery After Surgery Protocols following Emergency Laparotomy – A Systematic Review and Meta-Analysis of Randomised Clinical Trials. The American Journal of Surgery. DOI: https://doi.org/10.1016/j.amjsurg.2024.115857.

 


Updated Guidelines on Perioperative Management of Anticoagulant and Antiplatelet Therapy for Interventional Techniques – Pain Physician

18 Aug, 2024 | 14:52h | UTC

Introduction: The American Society of Interventional Pain Physicians (ASIPP) has published updated guidelines for the perioperative management of patients undergoing interventional techniques while receiving antiplatelet and anticoagulant therapy. These guidelines are essential for clinicians to balance the risk of thromboembolism against the risk of bleeding during interventional procedures.

Key Points:

1 – Risk of Thromboembolic Events:

– Thromboembolic events have a higher risk of morbidity and mortality compared to the risk of epidural hematoma. Thus, interruption of antithrombotic therapy should be carefully considered.

2 – Risk Stratification of Procedures:

– Interventional techniques are classified into three categories based on risk: low, moderate, or high. For high-risk procedures, cessation of anticoagulant or antiplatelet therapy is recommended, whereas for low to moderate-risk procedures, therapy may continue under certain conditions.

3 – Management of Direct Oral Anticoagulants (DOACs):

– DOACs such as dabigatran, apixaban, rivaroxaban, and edoxaban should generally be discontinued for 2 days before high-risk procedures and one day for moderate-risk procedures. Adjustments are needed based on renal function, specially for dabigatran.

4 – Discontinuation of Aspirin:

– For high-risk interventional procedures, discontinuation of aspirin (81 or 325 mg) is recommended 6 days before the procedure. However, for low to moderate-risk procedures, aspirin therapy may be continued or stopped for 3 days depending on individual risk factors and clinical judgment.

5 – Discontinuation of Other Antiplatelet Agents:

– Clopidogrel (Plavix) and Prasugrel (Effient): These agents should be discontinued 6 days before high-risk procedures. For low-risk procedures, these medications can be continued.

– Ticagrelor (Brilinta): Discontinue for 5 days before high-risk procedures, with consideration of patient-specific risk factors.

6 – Timing for Restarting Therapy:

– Antithrombotic therapy should typically be resumed within 12-24 hours after low to moderate-risk procedures and within 24-48 hours after high-risk procedures, depending on bleeding risk and patient status.

7 – Shared Decision-Making:

– Decisions on whether to continue or discontinue antithrombotic therapy should involve shared decision-making between the patient, the interventional pain specialist, and other treating physicians, considering all associated risks.

Conclusion: These guidelines provide a comprehensive framework for managing the delicate balance between thromboembolic and bleeding risks in patients on anticoagulant or antiplatelet therapy undergoing interventional procedures. They emphasize the importance of personalized care and multidisciplinary collaboration.

Guideline Reference: Manchikanti, L., et al. (2024). Perioperative Management of Antiplatelet and Anticoagulant Therapy in Patients Undergoing Interventional Techniques: 2024 Updated Guidelines From The American Society Of Interventional Pain Physicians (ASIPP). Pain Physician, 27(S1-S94).

 


Review: Prevention and Management of Device-Associated Complications in the Intensive Care Unit – The BMJ

17 Aug, 2024 | 20:04h | UTC

Introduction:

This review article, published by experts from the David Geffen School of Medicine at UCLA, focuses on the complications associated with invasive devices commonly used in the Intensive Care Unit (ICU). While these devices are essential for managing critically ill patients, they also pose significant risks, necessitating a thorough understanding of their potential complications and strategies for prevention and management.

Key Points:

1 – Central Venous Catheters (CVCs):

– CVCs are widely used in ICU patients but carry risks like vascular injury, pneumothorax, thrombosis, and infection.

– Use of real-time ultrasound guidance and careful operator technique are crucial for minimizing these risks.

– Prompt removal of unnecessary CVCs is essential to reduce the risk of complications.

2 – Arterial Catheters:

– Commonly used for hemodynamic monitoring, these catheters can lead to complications such as vascular occlusion, nerve injury, and infection.

– Ultrasound guidance is recommended to reduce the risk of complications, and catheters should be discontinued as soon as clinically feasible.

3 – Airway Devices (Endotracheal Tubes and Tracheostomies):

– Complications include laryngeal injury, tracheal stenosis, and tracheomalacia.

– Strategies to reduce these risks include minimizing intubation attempts, ensuring proper tube placement, and managing cuff pressures carefully.

4 – Extracorporeal Membrane Oxygenation (ECMO):

– ECMO is associated with significant complications, including bleeding, thromboembolic events, and neurologic injuries.

– Proper cannulation technique and vigilant monitoring are essential to mitigate these risks.

5 – Infection Control:

– Strict adherence to aseptic techniques and the use of chlorhexidine-impregnated dressings are recommended to prevent device-associated infections.

Conclusion:

This review underscores the importance of judicious use and timely removal of invasive devices in the ICU to minimize complications. Healthcare professionals must remain vigilant and employ best practices to prevent and manage these complications effectively.

Reference: Hixson, R., Jensen, K. S., Melamed, K. H., & Qadir, N. (2024). Device associated complications in the intensive care unit. BMJ, 386, e077318. http://dx.doi.org/10.1136/bmj-2023-077318

 


RCT: Hypothermic Oxygenated Perfusion Trends Toward Lower Primary Graft Dysfunction in Heart Transplantation – The Lancet

17 Aug, 2024 | 19:38h | UTC

Study Design and Population: This randomized, controlled, open-label, multicenter clinical trial evaluated the safety and efficacy of hypothermic oxygenated machine perfusion (HOPE) compared to static cold storage (SCS) in preserving donor hearts for transplantation. Conducted across 15 transplant centers in eight European countries, the study enrolled 229 adult heart transplant candidates between November 2020 and May 2023. The trial included 204 patients who received a transplant and met the study’s inclusion and exclusion criteria.

Main Findings: The primary composite endpoint, including cardiac-related death, graft dysfunction, and rejection within 30 days post-transplant, occurred in 19% of patients in the HOPE group compared to 30% in the SCS group, reflecting a 44% risk reduction (HR 0.56, 95% CI 0.32–0.99, p=0.059). Notably, primary graft dysfunction was significantly lower in the HOPE group (11% vs. 28%, RR 0.39, 95% CI 0.20–0.73). The incidence of major adverse cardiac transplant events was also reduced with HOPE (18% vs. 32%, RR 0.56, 95% CI 0.34–0.92).

Implications for Practice: HOPE showed a potential clinical benefit by reducing the incidence of primary graft dysfunction and major adverse cardiac events after heart transplantation. Although the primary endpoint was not statistically significant, the observed risk reductions suggest that HOPE could improve outcomes in heart transplantation. Further research is needed to confirm these findings and optimize donor heart preservation strategies.

Reference: Rega, F., Lebreton, G., Para, M., Michel, S., Schramm, R., Begot, E., et al. (2024). Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial. The Lancet, 404(10453), 670-682. DOI: https://doi.org/10.1016/S0140-6736(24)01078-X.

 


RCT: Routine Protamine Administration Enhances Hemostasis and Reduces Vascular Complications in TAVI – JAMA Cardiol

17 Aug, 2024 | 19:09h | UTC

Study Design and Population: The ACE-PROTAVI trial was a double-blind, placebo-controlled randomized clinical trial conducted at three Australian hospitals. It involved 410 patients (median age 81 years) undergoing transfemoral transcatheter aortic valve implantation (TAVI). The trial evaluated the efficacy and safety of routine protamine administration versus placebo.

Main Findings: Patients receiving protamine showed a higher rate of successful hemostasis (97.9% vs. 91.6%) and a significantly shorter time to hemostasis (median 181 vs. 279 seconds). Protamine administration also led to a reduced risk of composite vascular complications (5.2% vs. 12.8%), primarily due to fewer minor vascular events. No adverse events were associated with protamine.

Implications for Practice: Routine protamine administration after TAVI improves hemostasis, reduces minor vascular complications, and shortens procedural and postprocedural recovery times, suggesting it should be considered in standard TAVI protocols.

Reference: Vriesendorp, P. A., Nanayakkara, S., Heuts, S., et al. (2024). Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial. JAMA Cardiology. Published online August 14, 2024. DOI: 10.1001/jamacardio.2024.2454.

 


New AHA Guidelines for Managing Elevated Blood Pressure in Acute Care Settings – Hypertension

13 Aug, 2024 | 13:13h | UTC

Introduction:

The American Heart Association (AHA) has released a scientific statement focusing on the management of elevated blood pressure (BP) in acute care settings. This guideline addresses the significant variation in practice due to a lack of robust evidence for managing BP in such environments, particularly in emergencies or when elevated BP is asymptomatic.

Key Points:

1 – Classification of Elevated BP: Elevated BP in acute care settings is categorized into asymptomatic elevated BP and hypertensive emergency, the latter requiring immediate treatment due to acute target-organ damage.

2 – Hypertensive Emergency: Immediate treatment is necessary for patients with BP >180/110–120 mm Hg and evidence of new or worsening target-organ damage, typically using intravenous antihypertensive medications in a closely monitored environment.

3 – Asymptomatic Elevated BP: In cases where elevated BP is present without symptoms or target-organ damage, the use of antihypertensive medications should be approached cautiously. Recent studies suggest potential harm from aggressive treatment, highlighting the importance of verifying BP readings and identifying reversible causes before intervention.

4 – Proper BP Measurement: Accurate BP measurement is crucial. The guidelines stress using recently calibrated devices and following correct measurement techniques to avoid unnecessary treatment due to erroneous readings.

5 – PRN Orders: The use of “as needed” (PRN) antihypertensive medications for asymptomatic elevated BP is discouraged due to the risks of overtreatment and variability in BP control, which can lead to adverse outcomes.

6 – Treatment Thresholds: The guidelines recommend a high threshold for initiating or intensifying antihypertensive treatment in asymptomatic patients, emphasizing the need for repeated measurements and assessment of underlying causes.

7 – Post-Discharge Care: It is crucial to maintain prehospital antihypertensive regimens and avoid intensification at discharge unless clearly indicated. Effective care coordination and patient education are vital for successful transitions from hospital to home care.

Conclusion:

These guidelines represent a significant step toward standardizing BP management in acute care settings. By focusing on accurate measurement, cautious treatment of asymptomatic elevated BP, and proper follow-up, clinicians can reduce unnecessary interventions and improve patient outcomes.

Guideline Reference: Bress, A.P., et al. (2024). “The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement from the American Heart Association.” Hypertension, 81–e106.

 


RCT: Eliminating Fasting Before Contrast-Enhanced CT in Outpatients Reduces Nausea and Vomiting Without Increasing Acute Adverse Reactions – Insights Imaging

11 Aug, 2024 | 13:41h | UTC

Study Design and Population: This single-center, randomized clinical trial was conducted in Spain with 1,103 adult outpatients undergoing non-emergency contrast-enhanced CT scans. Patients were randomized into two groups: one group fasted for at least 6 hours (control), while the other group had no food restrictions (intervention). The primary aim was to assess whether eliminating fasting affects the incidence of acute adverse reactions (AARs), such as nausea and vomiting.

Main Findings: The study found no significant difference in the overall incidence of acute adverse reactions between the fasting and non-fasting groups (3.21% vs. 2.30%; p = 0.36). However, the non-fasting group had a significantly lower incidence of nausea and vomiting (0.92% vs. 2.86%; p = 0.02). Multivariate logistic regression identified fasting, age, allergies, neurological diseases, and contrast media concentration as independent risk factors for nausea and vomiting.

Implications for Practice: The findings suggest that the traditional practice of fasting before contrast-enhanced CT scans is unnecessary and may increase the risk of nausea and vomiting. Therefore, unrestricted food intake should be allowed for most contrast-enhanced CT exams, reserving fasting only for specific imaging procedures.

Reference: Zitan Saidi et al. (2024). Fasting before contrast-enhanced CT and the incidence of acute adverse reactions: a single-center randomized clinical trial. Insights into Imaging, 15(195). DOI: 10.1186/s13244-024-01767-9.

 


Meta-Analysis: Daily Sedation Interruption Shortens PICU Stay Without Impacting Mortality or Ventilation Duration in Pediatric MV Patients – JAMA Netw Open

11 Aug, 2024 | 13:19h | UTC

Study Design and Population: This systematic review and meta-analysis included six randomized clinical trials (RCTs) involving 2,810 pediatric patients receiving mechanical ventilation (MV) in the pediatric intensive care unit (PICU). The trials compared the effects of daily sedation interruption (DSI) with continuous intravenous (IV) sedation on clinical outcomes such as MV duration and PICU length of stay.

Main Findings: The analysis found that DSI was associated with a significant reduction in the length of PICU stay (mean difference of -1.45 days, p = 0.03). However, there was no significant difference in the duration of MV between DSI and continuous sedation (mean difference of -0.93 days, p = 0.06). Additionally, there were no significant differences in total sedative doses, adverse events, or mortality between the two groups.

Implications for Practice: The findings suggest that DSI may reduce the length of PICU stay without increasing the risk of adverse events, making it a potentially valuable strategy in managing sedation for pediatric patients on MV. However, further research is needed to explore the long-term neurodevelopmental outcomes associated with DSI.

Reference: Shu Wen Toh, T. et al. (2024). Daily Sedation Interruption vs Continuous Sedation in Pediatric Patients Receiving Mechanical Ventilation: A Systematic Review and Meta-analysis. JAMA Network Open, 7(8), e2426225. DOI: 10.1001/jamanetworkopen.2024.26225.

 


RCT: Intravenous Amino Acids Reduce AKI Incidence in Cardiac Surgery Patients – N Engl J Med

3 Aug, 2024 | 19:12h | UTC

Study Design and Population: In this multinational, double-blind, randomized clinical trial, 3511 adult patients scheduled for cardiac surgery with cardiopulmonary bypass were recruited from 22 centers across three countries. Patients were randomly assigned to receive an intravenous infusion of either a balanced mixture of amino acids (2 g/kg/day) or a placebo (Ringer’s solution) for up to three days.

Main Findings: The primary outcome, occurrence of acute kidney injury (AKI), was significantly lower in the amino acid group (26.9%) compared to the placebo group (31.7%) with a relative risk of 0.85 (95% CI, 0.77 to 0.94; P=0.002). The incidence of severe AKI (stage 3) was also reduced in the amino acid group (1.6% vs. 3.0%; relative risk, 0.56; 95% CI, 0.35 to 0.87). There were no substantial differences between the groups regarding secondary outcomes such as the use and duration of kidney-replacement therapy or all-cause 30-day mortality.

Implications for Practice: The infusion of amino acids in adult patients undergoing cardiac surgery appears to reduce the incidence of AKI, indicating a potential protective renal effect. However, this intervention did not significantly impact other secondary outcomes, including mortality and the use of kidney-replacement therapy. These findings suggest that amino acids could be considered as a strategy to mitigate AKI risk in this patient population, although further research is needed to explore long-term benefits and other clinical outcomes.

Reference: Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, for the PROTECTION Study Group. (2024). A randomized trial of intravenous amino acids for kidney protection. New England Journal of Medicine, 390(24), 1765-1774. DOI: 10.1056/NEJMoa2403769.


RCT: Liberal vs. Restrictive Transfusion Strategy Shows No Significant Difference in Neurologic Outcomes for Traumatic Brain Injury Patients – N Engl J Med

3 Aug, 2024 | 19:06h | UTC

Study Design and Population: This randomized clinical trial evaluated the effects of liberal versus restrictive red cell transfusion strategies in 742 adults with moderate to severe traumatic brain injury (TBI) and anemia. Participants were randomized to either a liberal transfusion strategy (initiated at hemoglobin ≤10 g/dL) or a restrictive strategy (initiated at hemoglobin ≤7 g/dL). The primary outcome was an unfavorable neurologic outcome at 6 months, assessed using the Glasgow Outcome Scale–Extended.

Main Findings: The study found that 68.4% of patients in the liberal-strategy group and 73.5% in the restrictive-strategy group experienced an unfavorable outcome (adjusted absolute difference of 5.4 percentage points; 95% CI, −2.9 to 13.7). No significant difference in mortality or depression was observed between the two groups. Although some functional independence and quality of life measures were better in the liberal group among survivors, venous thromboembolic events and acute respiratory distress syndrome rates were comparable.

Implications for Practice: The findings indicate that a liberal transfusion strategy does not significantly improve neurologic outcomes at 6 months in critically ill TBI patients compared to a restrictive strategy. Clinicians may consider maintaining a restrictive transfusion strategy, given the similar outcomes and potential for fewer transfusions. Further research is needed to explore specific subgroups that might benefit from different transfusion strategies.

Reference: Turgeon AF, Fergusson DA, Clayton L, et al. (2024). Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. New England Journal of Medicine, 390(24), 1234-1245. DOI: 10.1056/NEJMoa2404360.


Guidelines on the use of intravenous albumin in various clinical settings – CHEST

25 May, 2024 | 18:49h | UTC

The International Collaboration for Transfusion Medicine Guidelines provides comprehensive guidelines on the use of intravenous albumin across various clinical settings, including critical care, cardiovascular surgery, kidney replacement therapy, and complications of cirrhosis. The guideline emphasizes that there are few evidence-based indications supporting the routine use of albumin to improve patient outcomes. Key findings include:

 

1 – Critical Care: Limited recommendations for using albumin in adult, pediatric, and neonatal critical care, primarily advising against its routine use for volume replacement or managing hypoalbuminemia due to low or very low certainty of evidence.

2 – Cardiovascular Surgery: No recommendations for using albumin to prime cardiovascular bypass circuits or for volume replacement due to moderate to very low certainty of evidence.

3 – Kidney Replacement Therapy: Albumin is not suggested for preventing or managing intradialytic hypotension or improving ultrafiltration due to very low certainty of evidence.

4 – Cirrhosis Complications: Some conditional recommendations for using albumin in specific scenarios like large-volume paracentesis and spontaneous bacterial peritonitis due to low certainty of evidence; however, it is generally not suggested for other complications of cirrhosis.

 

Overall, the guidelines advise a cautious approach to albumin use, highlighting the need for more robust evidence to support its broader application in clinical practice.

 

Reference (link to free full-text):

Callum J et al. (2024). Use of Intravenous Albumin: A Guideline From the International Collaboration for Transfusion Medicine Guidelines. CHEST, 2024. DOI: https://doi.org/10.1016/j.chest.2024.02.049.

 


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