SIH: Trials and Research Endeavors. Tim Amrhein, MD Assistant Professor of Neuroradiology Duke University Medical
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1 SIH: Trials and Research Endeavors Tim Amrhein, MD Assistant Professor of Neuroradiology Duke University Medical
2 Disclosures No relevant disclosures RSNA Research Scholar Grant ASNR Comparative Effectiveness Award NIH R01
3 Objectives Getting from here to there Types of research What is good research? Where are we now? Where are we going?
4 Getting From Here to There
5 Getting From Here to There Myocardial Infarction 1912 (JAMA): wound of heart physical and emotional rest quiet isolation in bed 6 wks 2018 (JAMA): myocardial reperfusion ECG, blood markers, echo, medications (thrombolytics), cath lab, stenting, ICU Herrick JB. JAMA 1912; 59:
6 Getting From Here to There Myocardial Infarction 1912 (JAMA): wound of heart physical and emotional rest quiet isolation in bed 6 wks 2018 (JAMA): myocardial reperfusion ECG, blood markers, echo, medications (thrombolytics), cath lab, stenting, ICU Ibanez et al Eur Heart Journal; 39(2):
7 Myocardial Infarction RESEARCH!!!
8 General Research Goals Create generalizable knowledge Determine: best treatments, causation, prevalence of disease
9 Types of Research
10 Expert Opinion Statements of opinion from thought leader Can say whatever they want Claim s validity based on person making claim rather than evidence Conflicts of interest industry / financial, personal Bias: based on single person s experience limited in scope
11 Expert Opinion Miasma theory of disease cholera, chlamydia, plague caused by bad air or pollution 1880: germ theory Nottingham Journal Aug 4th 1832
12 Case Series Report one or multiple patients with same disease or treatment PROS Describes characteristics Easy, Low cost, Less time Generate hypothesis CONS No control or comparison group Information bias Selection bias Useful for: Reporting sentinel events: toxicity of therapy, recognition of epidemics, initial identification of new disease
13 Case Series Report one or multiple patients with same disease or treatment CONS No control or comparison group Information bias Selection bias Useful for: Reporting sentinel events: toxicity of therapy, recognition of epidemics, initial identification of new disease
14 Case Series Report one or multiple patients with same disease or treatment PROS Describes characteristics Easy, Low cost, Less time Generate hypothesis CONS No control or comparison group Information bias Selection bias Useful for: Reporting sentinel events: toxicity of therapy, recognition of epidemics, initial identification of new disease
15 Case Control Retrospective Two groups: Case: group of subjects with disease Control: similar group of subjects without disease Look for differences in predictors of disease (e.g. smoking in lung cancer) Odds Ratio: relative risk of developing disease
16 Case Control PROS Efficiency for rare diseases Example: SIH in Ehlers-Danlos (made up numbers) 0.16% incidence SIH in non-eds assume relative risk 50 80% power 6000 patients cohort or RCT multiple years follow 16 each group for case-control
17 Case Control PROS Efficiency for rare diseases Relatively easy and low cost Generate hypothesis CONS Only one outcome studied Cannot estimate prevalence
18 Case Control PROS Efficiency for rare diseases Relatively easy and low cost Generate hypothesis CONS Only one outcome studied Cannot estimate prevalence Sampling bias Retrospective measurement bias
19 Cohort Studies Longitudinal studies: patient group assembled at beginning repeated data acquired over time in same patients Only observing, no active intervention Retrospective or prospective Two purposes: descriptive and analytic Can suffer from confounding
20 Randomized Controlled Trials (RCT) Prospective Experimental : active intervention Patients are randomly assigned to arms of study Eliminates confounding and reduces bias Gold standard Difficult, time consuming, expensive
21 What is good research? How to avoid fake news
22 Levels of Evidence Sacket DL et al How to Practice and Teach EBM
23 Where are we now?
24 Past Research
25 Past Research
26 Past Research
27 Expert Opinion Off label use of Gd in CSF space May be helpful to find slow leaks and CVFs Unsure of risks Advocates for its use in selected cases
28 Expert Opinion Opinion against MR myelography States that lumbar puncture in patients with CSF leaks could be risky Cites no evidence
29 Case Series First description of CSF to venous fistulas: 3 patients Pros: describe new findings basis for more research Cons: selection bias: doesn t tell us much about patients with CVFs no comparator group
30 Case Series Single patient CSF leak at C2 Successful treatment via targeted cervical patch Concludes targeted patching needed 25 patients 3 with C2 contrast All had surgically proven CSF leak elsewhere Contrast spills out at C1/2 à false localizing
31 Cross-Sectional Study 568 patients Three types: Type 1: dural tear (27%) Type 2: diverticula (42%) Type 3: CSF venous fistula (2.5%) Indeterminate (29%) Snapshot in time prevalence of disease describes characteristics of subtypes Limitations: referral / selection bias difficult to confirm causal relationships between predictors and SIH subtypes Study type does not answer questions about comparative efficacy of different treatments
32 Cohort Studies Several retrospective observational studies No prospective studies Strengths: less costly and time-consuming than prospective and RCTs allows for inference of causality Weaknesses: limited control over quality and nature of data may not have outcomes measured correctly or systematically confounding
33 Cohort Studies Several retrospective observational studies No prospective studies Strengths: less costly and time-consuming than prospective allows for inference of causality Weaknesses: limited control over quality and nature of data may not have outcomes measured correctly or systematically confounding
34 Evidence for EBP in Treatment of SIH Author Year # Patients # BP Targeted or Blind Pro/Retro Outcome metric Follow up Estimate of efficacy He T Retro Subjective 1-7 years 88% with first patch, 7% second, 4% third, 0.6% fourth. Wu T Retro Subjective 48 hr Cho T + B Retro Subjective 6 mos- 5.2 years 59% with first patch, 33% second, 6% third. 2 pts (1.3%) not cured 87% (targeted) vs 52% blind (p<0.05) EBP vs. Conservative 77% vs. 40% (p<0.05) Response to 1 st EBP Ferrante B Retro NS 1 mo, 3mos, 6mos-5yrs 90% with first, 5% second, 5% third 36-90% Chung (mean) Berroir B Retro VAS decrease >90% T + B Retro Subjective 1 mo 77% (targeted), 77% blind, 40% conservative 1 month, 1-4 years Sencakova T + B Retro NS NS 90% immediate relief, one third relapsed. Of relpases, 66% cured with second EBP. Total 'cure' 77% 36% with 1st patch, 20% with second, then 6 went to surgery and 4 had 3-6 additional patches. Logistic regression showed trend toward improvement with targeting (p=0.07), OR not reported. Targeted vs. Blind 87% vs 52% (p<0.05) Courtesy of Dr. Peter Kranz
35 Randomized Controlled Trials Prospective, blinded, and randomized Randomization eliminates confounding Blinding reduces bias Gold standard SIH Literature: NONE
36 Randomized Controlled Trials Vertebroplasty: place large needles into a vertebral body fracture inject cement to fix fracture Industry sponsored case and unblinded nonrandomized studies suggested efficacy Based on this à billion $ industry in USA No prior RCTs
37 Randomized Controlled Trials 131 patients Randomized to vetebroplasty or simulated procedure Improvements in both groups No difference between the two groups! Kallmes et al N Engl J Med 2009;361:569-79
38 Where are we going?
39 Cohort Studies Prospective observational studies Cedars-Sinai, Duke, Mayo
40 Unification via Registry Centralized registry: GUIDs Maximize: geographic reach data heterogeneity data completeness Allows for epidemiology
41 RCTs: The PATCH Trial Sponsored by RSNA RSG Duke single center Optimal treatment vs. Simulated procedure Prove patching works
42 Primary Endpoint: HIT-6 at 1 month (reduction from Spontaneous Intracranial Hypotension CT or dynamic myelogram positive for CSF leak Inclusion Criteria: Adult Meets ICHD-3 SIH criteria MRI Brain with contrast Definite CSF leak on myelography Baseline HIT-6 > 56 The PATCH Trial CT fluoroscopy-guided targeted blood and fibrin glue patch Eligible patients consented Baseline: HIT-6, MIDAS, NRS, EQ-5D, WPAI, Duke Headache Questionnaire Randomization CT fluoroscopy-guided targeted saline injection Exclusion Criteria: Contraindication or inability to undergo procedure Recent blood patch (< 2 weeks) Inability to provide informed consent Expected inability to complete follow up Contraindication to contrast media or fibrin glue immediate 2 weeks: Outcome measures 2 weeks: Outcome measures 1 week Assess for Adverse Events 1 months: Outcome measures 1 months: Outcome measures Patient Crossover Allowed 4 months: Outcome measures 4 months: Outcome measures 2 months Brain MRI: SIH findings
43 RCTs: Future Endeavors PATCH trial: multi-institutional Targeted vs. Non-targeted patching Blood vs. Fibrin glue
44 Conclusions Substantial progress over the past years! But, we have a long way to go! Quality research needed tough to do Requires: dedication, organization leadership, funding The future is bright
45 Thank you! Tim Amrhein, MD Assistant Professor of Neuroradiology Duke University Medical
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