Frontiers in Interventional Physiatry

Percutaneous Image-guided Lumbar Decompression Tom Haley, D.O. FAAPMR, DABPM

Disclosure • Consultant for Vertiflex Inc. • Previous Consultant for Vertos Medical – No vested interest

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Outline • • • • •

Patient selection Treatment options PILD product description Outcomes Clinical implications

Clinical Presentation

Extension provokes NIC symptoms:

Patients lean forward to ambulate more comfortably:

Sitting (flexion) provides some:

Leg pain/weakness

“Shopping Cart “ sign

Relief of symptoms

Neurogenic Intermittent Claudication Secondary to LSS: • Canal and foraminal space for nerve decrease in extension • Canal and foraminal space increase in flexion

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Neurogenic Intermittent Claudication Secondary to LSS: • Canal and foraminal space for nerve decrease in extension • Canal and foraminal space increase in flexion Treatment is directed towards limiting extension, opening up the canal and foraminal areas, and relieving pressure on the nerve roots. 6

Neurogenic Intermittent Claudication Secondary to LSS: • Ligamentum Flavum contributes 50-85% of spinal canal narrowing. • Treatment should first address the ligamentum flavum

Hansson, Eur Spine J. 2009 May; 18(5): 679–686.

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The Problem Lumbar spinal stenosis patients are suffering Narrowing of spinal canal causes pain, weakness, mobility issues

#1 reason for spine surgery in elderly

1.2M annual diagnoses

Many are fearful or poor candidates for traditional surgery

• 750k ESIs provide only temporary relief • 300k invasive surgeries

Lumbar Spinal Stenosis Continuum of Care Care Conservative Traditional Surgery

PILD

Physical Therapy / Opioids / ESI

• First line treatment • 32-52% success rate1,4 • Effectiveness diminishes as disease progresses

1. 2. 3. 4.

Laminectomy / Fusion

• Potential candidates

‒ Failed conservative care ‒ Non-surgical candidates

Weinstein JN, et al. SPORT Trial. Spine . 2010; 35(14):1329-1338. Deyo AD, et al. JAMA 2010; 303(13):1259-1265. Skidmore G, et al. Spine. 2011; 36(5):E345-E356. Atlas SJ, et al. The Maine Lumbar Spine Study. Spine. 2000; 25(5):556-562.

• Pts. w/ poor quality of life due to pain and weakness • 60-70% success rate1,4 • Significant complications ‒ 2-6% life threatening2 ‒ 6-23% re-op.1, 3 ‒ 8-13% re-hosp.2

• Longer recovery period • Elderly pts. often poor candidates (e.g. co-morbidities) 9

Percutaneous Lumbar Decompression Systems • Indications: – “specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.” • mild, Vertos Inc. • Totalis, Vertiflex Inc.

Rationale for Efficacy • Addresses the primary cause of stenosis-hypertrophic ligamentum flavum • Primary mechanism: debulking or thinning of hypertrophic ligamentum flavum – Removes posterior tension band – Reduces dynamic “buckling” • Secondary mechanisms: – Undercutting of bony ledges at superior and inferior laminar regions

PLD Benefits • Local anesthesia with mild sedation • Brief intraoperative time • Small Incision causes minimal muscular or ligament disruption • Rapid mobilization post-procedure • Can be performed in fluoroscopy suite or operating room setting • Rapid discharge to home (same day or day following) • Ideal for interventional pain physicians

Patient Selection •

Failed nonsurgical management –

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Continued functional decline –

E.g. walking less, sitting more

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Pain & leg heaviness has become more of an issue

“Moderately” impaired –

Able to walk