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Plastic Surgery

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

 


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

 


Changes to breast structure and function across a woman’s lifespan: implications for managing and modeling female breast injuries

19 Jul, 2023 | 14:29h | UTC

Changes to breast structure and function across a woman’s lifespan: Implications for managing and modeling female breast injuries – Clinical Biomechanics

Commentary: Breast injuries are common for female athletes. Here’s why better awareness and reporting are needed – The Conversation

 


RCT | Total breast reconstruction with autologous fat transfer using an expansion device vs implants in patients with breast cancer

28 Jun, 2023 | 13:12h | UTC

Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial – JAMA Surgery (link to abstract – $ for full-text)

See also: Visual Abstract

Author Interview: Effect of Breast Reconstruction With Autologous Fat Transfer vs Implants on Quality of Life – JAMA

 


Editorial | How to become a good surgeon

22 Jun, 2023 | 15:12h | UTC

How to become a good surgeon – Advances in Ophthalmology Practice and Research

 


SR | Efficacy of negative pressure wound therapy in treating pressure ulcers remains uncertain

31 May, 2023 | 13:53h | UTC

Negative pressure wound therapy for treating pressure ulcers – Cochrane Library

Summary: Negative pressure wound therapy for treating pressure ulcers – Cochrane Library

 


RCT | Effectiveness of nail bed repair in children with vs. without replacing the fingernail

4 Apr, 2023 | 13:33h | UTC

Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial – British Journal of Surgery

News Release: New approach to nail bed injury surgery could significantly cut NHS costs – University of Oxford

 


FDA issues new information on cases of squamous cell carcinoma and lymphomas around breast implants

16 Mar, 2023 | 13:28h | UTC

Summary: The US Food and Drug Administration (FDA) has provided an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature, including 3 reports of deaths from the disease.

While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence, and risk factors remain unknown. Health care providers and people who have or are considering breast implants should be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported to the FDA and in the literature.

The FDA continues to ask health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants.

FDA Safety Communication: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication – U.S. Food & Drug Administration

Commentary: FDA Issues Safety Communication on Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants – The ASCO Post

Related:

FDA Report: 660 Cases of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Study: Long-term Outcomes of Silicone Breast Implants

 


Instant noodle burns common in pediatric scald injuries: Study highlights need for prevention efforts

21 Feb, 2023 | 11:50h | UTC

Summary: The study examined pediatric scald burns at the University of Chicago Burn Center between 2010 and 2020 and found that 31% of burns were attributed to instant noodles. Children with instant noodle burns were typically older, more likely to be Black/African American, and from lower socio-economic backgrounds. They were also more likely to be unsupervised at the time of the injury. While instant noodle burns were smaller and required less operative intervention than other scald burns, some still required hospitalization and were associated with complications. The study highlights the need for targeted burn prevention efforts to reduce the incidence of these common but serious injuries.

Article: Pediatric instant noodle burns: A ten-year single center retrospective study – Burns (link to abstract – $ for full-text)

Commentary: Why Instant Noodles Are a Danger to Your Kids – HealthDay

 


Reconstructive burnout after mastectomy: implications for patient selection

16 Feb, 2023 | 15:02h | UTC

Reconstructive Burnout after Mastectomy: Implications for Patient Selection – Plastic and Reconstructive Surgery

News Release: ‘Reconstructive burnout’ – Study looks at patients who start breast reconstruction after mastectomy, but don’t complete it – Wolters Kluwer

Commentary: One in Four Patients Experience Breast Reconstruction Burnout – HealthDay

 


SR | Silicone gel sheeting for treating keloid scars

15 Feb, 2023 | 15:53h | UTC

Silicone gel sheeting for treating keloid scars – Cochrane Library

Summary: What are the benefits and risks of silicone gel sheeting for treating keloid scars? – Cochrane Library

 


Consensus Statement | Development of an Enhanced Recovery After Surgery (ERAS) surgical safety checklist

10 Feb, 2023 | 14:03h | UTC

Development of an Enhanced Recovery After Surgery Surgical Safety Checklist Through a Modified Delphi Process – JAMA Network Open

 

Commentary from the author on Twitter (thread – click for more)

 


RCT | Tissue adhesive, adhesive tape, and sutures for skin closure of pediatric surgical wounds

9 Feb, 2023 | 13:35h | UTC

Tissue adhesive, adhesive tape, and sutures for skin closure of paediatric surgical wounds: prospective randomized clinical trial – British Journal of Surgery

 


SR | Immediate breast reconstruction uptake in older women with primary breast cancer

1 Feb, 2023 | 13:04h | UTC

Immediate breast reconstruction uptake in older women with primary breast cancer: systematic review – British Journal of Surgery

 


FDA warns of risks of body sculpting

26 Jan, 2023 | 12:44h | UTC

FDA Warns of Risks of Body Sculpting – JAMA

Statement: Non-Invasive Body Contouring Technologies – U.S. Food & Drug Administration

 


Systematic Review | Reconstructive surgery for treating pressure ulcers – little evidence to guide recommendations.

18 Oct, 2022 | 12:46h | UTC

Reconstructive surgery for treating pressure ulcers – Cochrane Library

 


Systematic Review | Laser therapy for treating hypertrophic and keloid scars – not enough evidence to guide recommendations.

30 Sep, 2022 | 12:27h | UTC

Laser therapy for treating hypertrophic and keloid scars – Cochrane Library

Summary: Laser therapy for hypertrophic and keloid scars – Cochrane Library

 


RCT | Multiple doses of prophylactic intravenous antibiotics are no better than a single dose in implant-based breast reconstruction.

19 Sep, 2022 | 12:48h | UTC

Effectiveness of Single vs Multiple Doses of Prophylactic Intravenous Antibiotics in Implant-Based Breast Reconstruction: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 


RCT | In patients with severe burns, supplemental glutamine did not improve outcomes.

11 Sep, 2022 | 22:59h | UTC

A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 


Review | Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone.

18 Aug, 2022 | 12:34h | UTC

Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone – Clinical Rheumatology

 

Commentary on Twitter

 


RCT | Antiseptic skin agents to prevent surgical site infection after incisional surgery.

8 Aug, 2022 | 11:54h | UTC

Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study) – Annals of Surgery (link to abstract – $ for full-text)

Related:

Alcoholic chlorhexidine skin preparation or triclosan-coated sutures to reduce surgical site infection: a systematic review and meta-analysis of high-quality randomised controlled trials – The Lancet Infectious Diseases

Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial – The Lancet

 


M-A | Perioperative care bundles for the prevention of surgical-site infections.

2 Aug, 2022 | 12:30h | UTC

Perioperative care bundles for the prevention of surgical-site infections: meta-analysis – British Journal of Surgery

 


Cohort Study | Association between excision margins and local recurrence in 1407 patients with primary in situ melanomas.

1 Aug, 2022 | 12:03h | UTC

Association between excision margins and local recurrence in 1407 patients with primary in situ melanomas – Journal of the American Academy of Dermatology International

Commentary: Margin Size Associated With Risk of Local Recurrence From Melanoma In Situ – AJMC

 


Burden of pressure injuries: findings from the Global Burden of Disease study.

1 Aug, 2022 | 12:06h | UTC

Burden of Pressure Injuries: Findings From the Global Burden of Disease Study – Eplasty

 


Guideline | Eyelid surgery for upper visual field improvement.

28 Jul, 2022 | 13:19h | UTC

American Society of Plastic Surgeons Evidence-Based Clinical Practice Guideline: Eyelid Surgery for Upper Visual Field Improvement – Plastic and Reconstructive Surgery (free for a limited period)

 


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