The Safety of Lumbar Punctures. Samuel Frank, MD

Transcription

1 The Safety of Lumbar Punctures Samuel Frank, MD

2 Risk Factors Modifiable Non-Modifiable Gauge of spinal needle Needle shape Bevel orientation & angle of insertion Stylet replacement Operator experience Age Female gender Low BMI Hx of prior post-lp HA Hx of chronic HA NOTE: volume is not generally a risk factor Bezov et al Headache 2010;50:

3 Procedure-Related Risk Factors for Post-LP HA Bezov et al Headache 2010;50:

4 Procedure-Related Risk Factors for Post-LP HA Bezov et al Headache 2010;50:

5 Procedure-Related Risk Factors for Post-LP HA Bezov et al Headache 2010;50:

6 Procedure-Related Risk Factors for Post-LP HA Bezov et al Headache 2010;50:

7 Procedure-Related Risk Factors for Post-LP HA Bezov et al Headache 2010;50:

8 PPMI Lumbar Punctures All subjects enrolled in PPMI undergo LP at baseline, 6, 12 months and yearly (7 total). Preferred study LP technique: Seated position. L4-5 interspace 24 gauge Sprotte needle Acquisition of at least 15 mls CSF The small gauge needle requires aspiration of CSF Permitted by the atraumatic nature of the Sprotte needle. Subjects remained horizontal for at least 30 minutes following the procedure Intense physical activity was minimized for 24 hours. Adverse events were monitored by phone contact one week after LP completion.

9 Baseline Data Enrolled Subjects Variable PD Subjects (N = 423) Healthy Controls (N = 196) SWEDD Subjects (N = 64) Male Female Male Female Male Female Gender N (%) 277 (65.5%) 146 (34.5%) 126 (64.3%) 70 (35.7%) 40 (62.5%) 24 (37.5%) Age Mean Duration of Disease (Months) Mean NA NA BMI Mean (Min, Max) (19.85, 41.57) (16.85, 43.76) (20.73, 39.55) (17.53, 42.29) (23.70, 38.23) (21.31, 42.85) Race Caucasian 259 (93.5%) 132 (90.4%) 118 (93.7%) 64 (91.4%) 39 (97.5%) 22 (91.7%) African American 3 (1.1%) 3 (2.1%) 6 (4.8%) 3 (4.3%) 1 (2.5%) 0 (0.0%) Asian 5 (1.8%) 3 (2.1%) 0 (0.0%) 1 (1.4%) 0 (0.0%) 1 (4.2%) Other 10 (3.6%) 8 (5.5%) 2 (1.6%) 2 (2.9%) 0 (0.0%) 1 (4.2%) CSF Collection Collected 258 (93.1%) 137 (93.8%) 116 (92.1%) 63 (90.0%) 36 (90.0%) 22 (91.7%) Partial Collection 12 (4.3%) 5 (3.4%) 5 (4.0%) 6 (8.6%) 0 (0.0%) 1 (4.2%) Attempted, no collection 5 (1.8%) 2 (1.4%) 4 (3.2%) 1 (1.4%) 2 (5.0%) 1 (4.2%) Not Done 2 (0.7%) 1 (0.7%) 1 (0.8%) 0 (0.0%) 2 (5.0%) 0 (0.0%) Missing 0 (0.0%) 1 (0.7%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Mean CSF volume collected ~15cc

10 CSF Sample Collection

11 Fluoroscopic-Guided LPs

12 AE rates Column Group PD Subjects Healthy Controls SWEDD Subjects Adverse Event (N = 423) (N = 196) (N = 64) # of Subjects % of Subjects # of Events # of Subjects % of Subjects # of Events # of Subjects % of Subjects # of Events Total % % % 21 Headache Headache % % % 8 Intracranial hypotension 0 0.0% % % 0 Post lumbar puncture syndrome % % % 5 Injection Site Issues Injection site pain % % % 4 Injection site reaction 0 0.0% % % 0 Musculoskeletal Back pain 3 0.7% % % 3 Muscle spasms 0 0.0% % % 1 Muscle tightness 0 0.0% % % 0 Musculoskeletal discomfort 3 0.7% % % 0 Musculoskeletal pain 0 0.0% % % 0 Musculoskeletal stiffness 3 0.7% % % 0 Radicular Pain Radicular pain 1 0.2% % % 0 Sciatica 1 0.2% % % 0 Pain in extremity 1 0.2% % % 0 Syncope Cold sweat 1 0.2% % % 0 Syncope 1 0.2% % % 0 Presyncope 1 0.2% % % 0 Loss of consciousness 1 0.2% % % 0

13 Factors Examined as Contributions to AEs

14 Position

15 Weight Non-Significant Factors CSF volume Needle type All AEs combined Collection type (aspiration vs. gravity) LP site Having PD, SWEDD (but NOT HC!)

16 Significant Factors Site Higher rate of AEs when performed at L4-5 (vs. L3-4 or L2-3, p=0.0339) Position Higher rate of AEs when performed in the seated position (p=0.0003) Experience Higher risk for the first 10 LPs compared to to the subsequent LPs when at least 20 LPs were completed [RR=2.05 (CI 1.29, 3.27)] Sex & Age In female (but not male) subjects with PD, there was a higher age in those with AEs vs no AEs (60.9 vs years, p=0.0139). Based on a multivariate analysis of LP collection methods, adjusted for age and gender, incidence of post-lp headaches was significantly higher in younger subjects, females, and subjects who were in a sitting position during their LP.

17 Other Results No SAEs Mean duration of HA=4.4 days Pending analysis AEs by site Individual AE types (HA, back pain, etc) Retention Transient HA during procedure not reported Report of up to 17% of subjects during LP with 4% post- LP HA rate (Linker et al Neurology 2002)

18 Peskind et al 2005 How PPMI Compares

19 Thank You! Questions? Preferred position supine?

20 References Peskind et al. Safety and Acceptability of the Research Lumbar Puncture. Alzheimer Dis Assoc Disord 2005;19: Raskin NH. Lumbar puncture headache: a review. Headache 1990;30: Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2000;55: Braune HJ, Huffman G. A prospective double-blind clinical trial, comparing the sharp Quincke needle (22G) with an "atraumatic" needle (22G) in the induction of post lumbar puncture headache. Acta Neurol Scand 1992;86:50-54 Brockman K: The Post-Lumbar Puncture Syrndrome related to the Shape of the Lumbar Puncture Needle Point. Akt. Neurol. 1990;17: Carson D, Serpell M. Choosing the best needle for diagnostic lumbar puncture. Neurology 1996;47:33-37 Engelhardt A, Oheim S, Neundorfer B. Post -lumbar puncture headache: experiences with Sprotte's Atraumatic needle. Cephalagia 1992;12:259 Jager H, Schimrigk K, Haas A. Post Lumbar Puncture Headache-Prevention by Means of an Atraumatic Needle. Akt Neurol. 1991;18:61-64 Ohman S, Ernerudh J, Forsberg P, Roberg M, Vrethem M: Lower values for immunoglobulin M in Cerebrospinal fluid when sampled with an atraumatic Sprotte needle compared with conventional lumbar puncture Ann Clin Biochem. 1995;32: