Treatment of Osteoporotic and Pathologic Compression

Fractures from Metastatic Disease

David A. Wiles, MD FAANS

Neurosurgeon

July 27, 2019

DISCLOSURES

No financial disclosures

3

Balloon kyphoplastyVCF PREVALENCE

Vertebral Compression Fractures (VCFs)

• most common osteoporotic fractures affecting 1.4 million people worldwide2

• up to two thirds are undiagnosed3

• 5-fold increased risk of another fracture within 1 year3

Approximately 25% of post-menopausal women are affected by VCFs

4

Balloon kyphoplastyCLINICAL BENEFITS

Balloon Kyphoplasty has been shown in studies to provide clinical benefits compared to non-surgical management (NSM; e.g. bed rest, pain medications), including:

• Rapid and sustained pain relief1

• Enhanced quality of life1

• Improved mobility1

• Less use of narcotic analgesics1

• Comparable safety results1

Could your VCF patients benefit from some of these?

5

Balloon kyphoplastyCLINICAL BENEFITS

For VCF patients, interventional treatment, like Balloon Kyphoplasty, has been shown to provide significant benefits (compared to NSM).

(p<0.001) (p<0.0001)

6

Impacts to healthcare systemLOS, DISCHARGE RATE, READMISSIONMedicare claims data shows that the majority of BKP procedures are performed in an outpatient setting. The following slides show data analyses of inpatient procedures and do not reflect an outpatient setting. Each facility should consider their specific site of service mix.

Based on a literature review as of October 31, 2017, highlights of data are presented based on studies that met clinical search criteria:*

• Length of Stay: 4 from 36 manuscripts

• Discharge to Home: 3 from 49 manuscripts

• Readmission Rate: 1 from 8 manuscripts

NOTE: Inclusion criteria expanded to specifically require a review of all MDT-sponsored and MDT-funded BKP/VP clinical studies.*Medtronic data on file

INCLUSION EXCLUSION

• LOS• Hospital Stay• Discharge• Readmission

• Balloon Kyphoplasty, Kyphoplasty

• LOS , Discharge or readmission were not primary or secondary outcomes

• Vertebral Augmentation (BKP or VP) was the comparative group

• <10 patients

7

INPATIENT LENGTH OF STAY (LOS)LENGTH OF STAY IS AN IMPORTANT FACTORTO CONSIDER5-8

LOS is defined as the length of an inpatient episode of care, calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital. Patients admitted and discharged on the same day have a length of stay of less than one day (https://medical-dictionary.thefreedictionary.com/length+of+stay).

Study limitations: *This retrospective study does not show outcome measures such as pain scores and quality of life assessments; use of diagnosis and procedure codes does not permit characterization of the fractures or procedures; total charges were underestimated since physician payments are not part of the database; selection bias and insufficient data limit ability to understand all possible baseline attributes of VCF or other health issues or factors used for treatment decisions that may account for results observed.** Single center experience; data reflect LOS per observation year †p-value is from relative odds ratio differences ††Single center experience

Note: Becker S, et al. was not graphed in the Discharge-to-Home comparison as no formal analysis was reported. However, the authors noted that all BKP and NSM subjects could be discharged to home. Based on clinical literature review as of October 31, 2017; from PMD014522-4.0

6.0

4.96

3.74

5.45.3 5.39

7.38

5.2

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

Zampini JM, et al. 2010* Becker S, et al. 2011** Chen AT, et al. 2013* Ong KL, et al. 2017*

BKP

NSM

n=244p<0.046

n=68,752 p<0.001

2,077,944p<0.001 +

n=5,766,p<0.001

5766 OVCF from US Nationwide Inpatient Sample (NIS); 15.3% underwent BKP7

Between 2002 and 2005, n=244 (134 BKP; 110 NSM) patients were treated at the hospital8

100% US Medicare dataset; 2005n= 68,752 (55.6% NSM; 11.2% VP; 33.2% BKP)/ VP had 5.73 LOS6

Nu

mb

er

of

day

s

100% US Medicare dataset; 2005-2014n=2,077,944(81.8% NSM; 5.6% VP; 12.6% BKP)/ VP had 6.6 LOS5

Discharge to HomeBKP HAD GREATER LIKELIHOOD OF ROUTINE DISCHARGES TO HOME VS NSM5-7

8

Study limitations: *This retrospective study does not show outcome measures such as pain scores and quality of life assessments; use of diagnosis and procedure codes does not permit characterization of the fractures or procedures; total charges were underestimated since physician payments are not part of the database; selection bias and insufficient data limit ability to understand all possible baseline attributes of VCF or other health issues or factors used for treatment decisions that may account for results observed.†p-value is from relative odds ratio differences

Note: Becker S, et al. was not graphed in the Discharge-to-Home comparison as no formal analysis was reported. However, the authors noted that all BKP and NSM subjects could be discharged to home. Based on clinical literature review as of October 31, 2017; from PMD014522-4.0

38.4%

59.9%56.9%

21.0%24.3%

33.7%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Zampini JM, et al.2010* Chen AT, et al. 2013* Ong KL, et al. 2017*

BKP

NSM

n=68,752 p<0.001

n=5,766,p<0.001

5766 OVCF from US Nationwide Inpatient Sample (NIS); 15.3% underwent BKP7

100% US Medicare 2006 dataset; n=68,752 (55.6% NSM; 11.2% VP; 33.2% BKP) /VP had 39.0% discharge rate6

Dis

char

ge

to

Ho

me

100% US Medicare dataset; 2005-2014n=2,077,944 (81.8% NSM; 5.6% VP; 12.6%) BKP/ VP had 49.70% discharge rate5

2,077,944p<0.001 +

Readmission RateBKP HAD SIGNIFICANTLY LOWER READMISSION RATE VS NSM6,8

9

Study limitations: *This retrospective study does not show outcome measures such as pain scores and quality of life assessments; use of diagnosis and procedure codes does not permit characterization of the fractures or procedures; total charges were underestimated since physician payments are not part of the database; selection bias and insufficient data limit ability to understand all possible baseline attributes of VCF or other health issues or factors used for treatment decisions that may account for results observed.**Single center experience†p-value is from relative odds ratio differences

Based on clinical literature review as of October 31, 2017; from PMD014522-4.0

35.2%

61.9%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Chen AT, et al. 2013*

BKP

NSM

n=68,752 p<0.001

100% US Medicare 2006 dataset; n=68,752 (55.6% NSM; 11.2% VP; 33.2% BKP)/VP had 52.4% readmission rate6

Re

adm

issi

on

s

WITHIN 30 DAYS PER OBSERVATION YEAR

0.39

0.63

0.00

0.10

0.20

0.30

0.40

0.50

0.60

0.70

Becker S, et al. 2011**

BKP

NSM

n=244p=0.039

Between 2002 and 2005, n=244 (134 BKP; 110 NSM) patients were treated at the hospital8

Re

adm

issi

on

s

62% of Medicare inpatients treated with NSM were readmitted to the hospital within 30 days compared to 35% for BKP (p< 0.001)

The number of spine-relevant admissions per observation year after the first treatment was statistically significantly lower (p=0.039) in the BKP group compared to NSM

10

Balloon KyphoplastyPERSONALIZED SOLUTION

Minimally invasive, short procedure (typically around an hour)

• Orthopedic balloons are used to gently elevate the fractured vertebra in an attempt to return it to the correct position

• The cavity is then filled with bone cement, creating an internal cast to support the surrounding bone

• Can be performed under general or local anesthesia, either in hospital or physician office setting

• Can stabilize painful VCFs, reduce back pain, and restore vertebral body height1

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Balloon kyphoplastyPATIENT SELECTION

Common Signs of VCF9

• Sudden onset of back pain without obvious explanation (acute)

• Loss of height or Kyphosis

• Protruding abdomen (chronic)

Patient Selection

Activity-related axial pain corresponding to level of recent compression fracture

Pain decreases or disappears when lying down and/or sitting still

Tenderness over appropriate level of fracture

Complete neurological exam and radiographic evaluations

1. Boonen S, Van Meirhaeghe J, Bastian L, et al. Balloon kyphoplasty for the treatment of acute vertebral compression fractures:2-year results from a randomized trial. J Bone Miner Res. 2011;26(7):1627-1637.

2. International Osteoporosis Foundation Website. http://www.iofbonehealth.org/osteoporosis. May 2016. 3. Brunton S, Carmichael B, Gold D et al. Vertebral compression fractures in primary care recommendations from a consensus

panel. J Fam Pract. 2005 Sep;54(9):781-8.4. Ross PD. Clinical consequences of vertebral fractures. Am J Med. 1997;103(2A):30S-43S.5. Ong KL, Beall DP, Frohbergh M, et al. Were VCF patients at higher risk of mortality following the 2009 publication of the

vertebroplasty "sham" trials? Osteoporos Int. 2017 Oct 24. doi:10.1007/s00198-017-4281-z.6. Chen AT, Cohen DB, Skolasky RL. Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity

after vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2013;95(19):1729-1736.7. Zampini JM, White AP, McGuire KJ. Comparison of 5766 vertebral compression fractures treated with or without kyphoplasty.

Clin Orthop Relat Res. 2010;468(7):1773-1780.8. Becker S, Pfeiffer KP, Ogon M. Comparison of inpatient treatment costs after balloon kyphoplasty and non-surgical treatment

of vertebral body compression fractures. Eur Spine J. 2011; 20(8):1259–1264.9. Suzuki N, Ogikubo O, Hansson T. The course of the acute vertebral body fragility fracture: its effect on pain, disability and

quality of life during 12 months. Eur Spine J. 2008. DOI 10.1007/s00586-008-0753-3.

BALLOON KYPHOPLASTY REFERENCES

12

RF ABLATION

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RF ABLATIONCLINICAL RATIONALE

• Bone is invaded in 60-80% of patients with metastatic disease1 — most frequently among patients with primary malignancies of the breast, prostate, and lung.2

• The population of patients with metastatic cancer is growing due to increased life expectancy of cancer patients.3

• Patients may experience pain that is local, mechanical, radicular or a combination of any of these.4

What is your standard protocol when patients present with

confirmed or suspected metastatic spinal lesion(s)?

Preservation of neurologic

function

Pain relief

Stabilization of

mechanical structure

Treatment goals include

pain palliation and

improvement in QOL

achieved by4:

15

RF ABLATIONCLINICAL RATIONALE

In a systematic review by Sze et al, the authors noted that 40% of patients received no pain relief at all after RT.5

In a two-arm study by Distaso et al, overall pain response and interval to response showed to be 33% higher and 6 weeks faster for patients who received RFA + RT for bone metastases palliation compared to RT alone.6

16

RF ABLATIONPATIENT BENEFITS

Bone is invaded in 60-80% of patients with metastatic disease,1 most frequently amongst patients with primary malignancies of the breast, prostate, and lung.2

The most frequent complaint of patients with skeletal metastases is the pain associated with the disease,1 occurring in 79% of patients.7 The pain is usually refractory and affects quality of life.8 Metastatic lesions in the spine become painful due to neural compression, pathologic fracture or other biochemical mechanisms.9

79% of patients with skeletal metastases complain of pain

17

RF ABLATIONTECHNOLOGY OVERVIEW

This cooled RF ablation technology offers simultaneous, dual-probe capabilities for the treatment of bone tumors.

• Algorithm designed specifically for performance in bone

• Coaxial, bipolar probes (no grounding pads)

• Consistent energy delivery & predictable ablation zones with OsteoMAPSM

• Ability to customize ablation zones and offers a variety of probe sizes for procedure flexibility

• Utilizes same access instrumentation as kyphoplasty for easy follow-up with cement, where indicated, to stabilize the bone

1. Schulman et al. Economic Burden of Metastatic Bone Disease. American Cancer Society 2007. 2. Kurup AN, Callstrom MR. J Vasc Interv Radiol. 2010;21 (8 Suppl);S424-50.3. Wong DA, Fornasier VL, MacNab I. Spinal metastases: the obvious, the occult, and the imposters. Spine. (phila PA 1976)

1990;15:1-4.4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous

System Cancers V.1.07/25/2016. National Comprehensive Cancer Network, Inc 2016. All rights reserved. Accessed April 24, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

5. Sze WM, Shelley M, Held I, et al. Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy—a systematic review of the randomised trials. Cochrane Database Syst Rev. 2004;(2):CD004721.

6. Di Staso M, Zugaro L. Gravina GL, et al. A feasibility study of percutaneous Radiofrequency Ablation followed by Radiotherapy in the management of painful osteolytic bone metastases. Eur Radiol. 2011 Sep;21(9):2004-10. doi: 10.1007/s00330-011-2133-3. Epub 2011 May 1.

7. Janjan et al. Therapeutic Guidelines for treatment of bone metastases. J Palliat Med, 2009; 12(5):417-426.8. Nakatsuka A, Yamakado K, Maeda M, et al. Radiofrequency ablation combined with bone cement injection for the treatment of

bone malignancies. J Vasc Interv Radiol. 2004; 15:707-712.9. Wallace et al. Radiofrequency ablation and vertebral augmentation for palliation of painful spinal metastases. J Neuro Oncol.

2015;124(1):111-118.

REFERENCES

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