Minimally Invasive Lumbar Decompression (MILD )

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Minimally Invasive Lumbar Decompression (MILD ) Brian Durkin, DO Director, Center for Chronic Pain Department of Anesthesiology Stony Brook University, NY

MILD QA/QI Study TEAM Helene Benveniste, MD, PhD Laurie A. Shroyer, PhD (Surgery) Christopher Biel Jaimie Romeiser, MS Stacey Hildebrand, NP Laura Wahl Raphael Davis, MD (Neurosurgery) Robert Peyster, MD (Radiology) Sachin Jambawalikar, PhD (Radiology)

Epidemiology of chronic low back pain For each type of pain, respondents were asked, "During the past three months, did you have [type of pain]?" Respondents were instructed to report pain that had lasted a whole day or more, and conversely, not to report fleelng or minor aches or pains. Persons might be represented in more than one pain category The percentage of adults who had migraines or severe headaches, pain in the neck, lower back, or face/jaw, by sex in 2009. Females were more likely than males to have experienced a migraine or severe headache (21.8% versus 10.0%), pain in the neck (17.5% versus 12.6%), pain in the lower back (30.2% versus 26.0%), and pain in the face or jaw (6.6% versus 3.3%). For both sexes, pain in the lower back was the most common of these four types of pain, and pain in the face or jaw was the least common Pleis JR, Ward BW, Lucas JW. Summary health stalslcs for U.S. adults: NaLonal Health Interview Survey, 2009 (provisional report). Vital Health Stat 2010;10(249).

SymptomaLc Lumbar Spinal Stenosis The prevalence of lumbar spinal stenosis (LSS) in palents ranging from 60-69 years of age is eslmated to be 47% for relalve spinal stenosis and 20% for absolute stenosis 1.2 million physician office visits in the US are related to symptoms of LSS in elderly palents 125,000 laminectomy procedures were performed in 1995; and based on 2007 eslmates this number will surge as life expectancy increases

Clinical diagnosis of LSS Pain in the low back area, budocks, and/or legs in combinalon with neurogenic claudicalon. Neurogenic claudicalon occurs with erect postures such as standing or walking L3 L4 L5

Example s of palent s pain paderns VAS = 5/10 VAS = 8/10 VAS = 9/10

Causes of SymptomaLc LSS Ligamentum Flavum (LF) hypertrophy Facet joint hypertrophy Vertebral body osteophytosis Herniated discs Spondylolisthesis LSS can occur at a single or mullple levels Concurrent pathologies (i.e. LF, Facet joint hypertrophy and/or herniated discs)

Ligamentum Flavum Hypertrophy L2- L3 L4- L5

Ligamentum Flavum Hypertrophy

Other spine pathology can contribute to symptoms

Surgical Approaches for SymptomaLc LSS with radiculopathy Decompressive laminectomy (without fusion) Decompressive laminectomy with fusion X- Stop interspinous space (Standard open discectomy)

MILD

Minimally Decompressive Lumbar Decompression (MILD ) The palent can undergo the procedure under local anesthesia & MAC. The palent is posiloned in the prone posilon and an epidural needle is placed for contrast and visualizalon of the working space via fluoroscopy. central canal and requires 1-2 hours

MILD A 6- gauge portal cannula is posiloned under fluoroscopy guidance adjacent to the intra- laminar space The trocar is used to direct the sculplng or shaving instruments directly into the area Decompression is confirmed via changes in epidural contrast distribulon and contrast flow. The process can be performed at mullple levels and requires 1-2 hours

MILD (Deer et al., 2009) Pain Physician: January/February 2010; 13:35-41

MILD Pain Physician: January/February 2010; 13:35-41

RetrospecLve review of 90 cases

QA MILD Project Quality Plan

Inclusion/Exclusion Inclusion criteria All palents with primary leg pain (leg pain > low back pain) associated with localized hypertrophy of ligamentum flavum and central canal stenosis on MRI or CT scan (neuro- radiologist s criteria) All palents with low back pain and leg pain associated with localized hypertrophy of ligamentum flavum on MRI or CT scan (neuro- radiologist s criteria) Exclusion criteria: PaLents with low back pain associated with lumbar spine pathology not likely to improve by procedure (e.g. foraminal stenosis and/or disc bulge- hernialon compressing exilng nerve roots as determined by Dr. Peyster & Durkin) PaLents unable to tolerate 1-3 hr procedure in prone posilon DemenLa or inability to understand procedure and answer queslonnaires

PROJECT QUALITY PLAN Purpose & outcome goals: To assess pain scores and long- term funclonal status in palents with low back pain associated with ligamentum flavum hypertrophy and central canal stenosis before and aner the MILD procedure

Demographics of 11 MILD PaLents 5 Female; 6 male Average Age: 69.6 ± 11.5 years Average BMI: 31.3 ± 6.7 Race: White: 10; African- American: 1 Hx of tobacco use: 64% (aclve smokers: 9%) Opioids: 4 palents out of 11 (36%)

Co- morbidity in MILD PaLents (n=11) ASA STATUS: ASA II 5 palents; ASA III 6 palents

Low back pain descriptors Yes (%) No (%) Gait Instability 64% 34% Use of Walking Assistance Device 45% 55% Low back pain 100% - Leg pain at rest 81% 19% Neurogenic ClaudicaLon 100% - Baseline VAS pain score (0-10) 8.3 ± 1.8 -

MRI Diagnosis (based on 9 palents with MRIs) Level Canal Stenosis & LF hypertrophy L2- L3 Mild: 44% Moderate: 22% Severe: 34% L3- L4 Mild: 12% Moderate: 44% Severe: 44% L4- L5 Mild: 11% Moderate: 33% Severe: 56% L5- S1 Mild: 77% Moderate: 11% Severe: 22%

ODI status of MILD PaLents Prior to Procedure: ODI variable and most palents are relalvely funclonal The Oswestry Disability Index (ODI) is a validated, palent- completed queslonnaire used to assess 10 parameters: pain intensity, personal care, lixing, walking/walking aids, siyng, standing, sleeping, sex life, social life and travelling. Scores are from 0 to 100% with higher scores meaning greater disability.

% ODI improvements in four palents before and 1- month following MILD OUTCOME GOAL

RAW ODI scores in the 4 palents before and 1- month following procedure

VAS pain scores over Lme following MILD

Anterior view Anterior view Posterior view L1 L2 L3 LF Thecal sac Narrowing LF L5

Specific PreoperaLve services points H&P personal or family history of bleeding Ability to lie flat(prone) Labs as per our guidelines. CreaLnine (contrast used) Hold plavix /aspirin 325mg (7- )10 days (confirm with cardiol or prescribing physician) NSAIDs and baby aspirin OK to conlnue Anesthesia consult if ASA 3 or 4 Procedure is 1hr for 1 st level/30min /addilonal level. Prone, fluoroscopy IV sedalon Main OR if AICD/ home O 2/ bridging heparin needed