Outcomes of a Modified Treatment Ladder Algorithm Using Retrobulbar Amphotericin B for Invasive Fungal Rhino-Orbital Sinusitis

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Clinical Question

Can transcutaneous retrobulbar amphotericin B (TRAMB) reduce the risk of exenteration without compromising survival in patients with invasive fungal rhino-orbital sinusitis.

Bottom Line

Patients with invasive fungal rhino-orbital sinusitis that were treated with modified treatment ladder algorithm incorporating TRAMB had lower risk of exenteration without an increase in risk of mortality.

Major Points

When analyzing treatment of biopsy proven fungal rhino-orbital sinusitis with transcutaneous retrobulbar amphotericin B (TRAMB), TRAMB was associated with a lower a lower risk of exenteration and similar risk of mortality compared to historical controls that did not receive TRAMB.

Guidelines

Design

  • Retrospective, comparative clinic study with historical control subjects
  • N=50
  • Setting: Single tertiary institution
  • Enrollment: 1999-2020
  • Analysis: Quasiexperimental comparing post-2015 vs pre-2015 groups
  • Primary outcome: risk of exenteration and mortality

Population

Inclusion Criteria

  • Mucormycota
  • Presenting vision of NLP
  • Use of posaconzole

Exclusion Criteria

  • Complete ophthalmoplegia

Baseline Characteristics

  • Mean age: Pre-2015: 58.0, Post-2015: 2.0
  • Fungal Organism:
    • Nucormycota: Pre-2015: 8, Post-2015: 18
    • Ascomycota: Pre-2015: 12, Post-2015: 12
  • Underlying Diagnosis of Diabetes: Pre-2015: 10, Post-2015: 12
  • Underlying Diagnosis of Hematologic Malignancy: Pre-2015: 5, Post-2015: 9

There were no statistically significant differences in cause of immunosuppression, measures of severity of immunosuppression, causative fungal organism, or intracranial involvement.


Interventions

  • Randomized to intensive (targeting HbA1c <6%) or standard (HbA1c 7-7.9%) glycemic therapy

    • Then 46% were randomized to intensive (SBP <120) vs. standard (SBP <140) blood pressure therapy
    • Remaining 54% randomized to fenofibrate vs. placebo; all received statin
  • Intensive glycemic control group attended monthly visits for 4 months, then every 2 months, with additional visits and telephone calls as needed
  • Standard therapy group had glycemic control visits every 4 months

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

Annual rate of nonfatal MI or nonfatal stroke or cardiovascular death
2.11% vs. 2.29% (HR 0.90; 95% CI 0.78-1.04; P=0.16)

Secondary Outcomes

Annual rate of death from any cause
1.41% vs. 1.14% (HR 1.22; 95% CI 1.01-1.46; P=0.04)
Annual rate of cardiovascular death
0.79% vs. 0.56% (HR 1.35; 95% CI 1.04-1.76; P=0.02)

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading

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