painful vcfs: how and when to treat them?

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Painful VCFs: How and When to Treat Them?

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Painful VCFs: How and When to Treat Them?. Agenda. Background on VCFs Diagnosis New Information on Treatment Options A New, Implant-based Approach Case Studies Summary and Conclusions. Background. 750,000 Vertebral Compression Fractures (VCFs) in US each year caused by osteoporosis - PowerPoint PPT Presentation

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Page 1: Painful VCFs: How and When to Treat Them?

Painful VCFs: How and When to Treat Them?

Page 2: Painful VCFs: How and When to Treat Them?

Agenda

Background on VCFs

Diagnosis

New Information on Treatment Options

A New, Implant-based Approach

Case Studies

Summary and Conclusions

Page 3: Painful VCFs: How and When to Treat Them?

Background

750,000 Vertebral Compression Fractures (VCFs) in US each year caused by osteoporosis

Osteoporosis causes twice as many spinal fractures than hip fractures

Yet VCFs often go undiagnosed and untreated

Estimated that two-thirds of VCFs are never diagnosed Many patients dismiss their back pain as a sign

of aging and/or arthritis

Page 4: Painful VCFs: How and When to Treat Them?

Similar Mortality in Hip Fracture and VCF Patients

Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Page 5: Painful VCFs: How and When to Treat Them?

BalancedForceConcentration

ForceTransmission

Biomechanics of Kyphosis: “Kyphosis begets Kyphosis”

Page 6: Painful VCFs: How and When to Treat Them?

VCFs Increase Risk of Subsequent Fragility Fracture

Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Page 7: Painful VCFs: How and When to Treat Them?

Consequences of Kyphosis

• Deformity

• Debilitation

• Disability

• Depression

• Death

Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Page 8: Painful VCFs: How and When to Treat Them?

Diagnosis

Patients may experience either: Sudden onset of severe, “knifelike" back pain Chronic or gradual onset of back pain that worsens when

standing or walking

Courtesy of Nucleus Medical Art, Inc.

Additional symptoms of multiple VCFs: Eventual loss of height, as much as six

inches over time Kyphosis (curved back), commonly called a

dowager’s hump Stomach complaints Hip pain Breathing problems

Page 9: Painful VCFs: How and When to Treat Them?

Treatment of Symptomatic VCFs

Treatment options:

Bed rest for severe pain Prolonged pain and rest leads to loss of function and

possible loss of independence

Analgesics and opoids

Physical therapy

Bracing

Steroid injections

Minimally Invasive Vertebral Augmentation Vertebroplasty Balloon kyphoplasty

Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Page 10: Painful VCFs: How and When to Treat Them?

FREE Study Shows Benefits of BKP Treatment

FREE: Fracture REduction Evaluation Study 300 patient, multicenter, randomized, controlled study

designed to compare BKP to non-surgical care for acute VCF patients

Trial results were published in The Lancet and demonstrated

BKP patients had improved outcomes in terms of pain reduction, quality of life, function and mobility compared to non-surgical care

BKP had increased rates of new fractures (33%) compared to non-surgical care (25%) at one year

Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE) Study, Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Lancet. 2009 Mar 21;373(9668):1016-24. Epub 2009 Feb 24.

Page 11: Painful VCFs: How and When to Treat Them?

FREE Study Shows Benefits of Earlier BKP Treatment

• On average, the BKP patients in FREE were treated at 5.6 weeks

• By one month post-treatment, compared to non-surgical patients, BKP patients experienced:

Greater improvement on most measures

• Findings suggest that BKP may be considered earlier to provide faster pain relief and improved function.

Page 12: Painful VCFs: How and When to Treat Them?

Vertebral Augmentation: Room for Improvement

Unmet needs:

Decrease:New fracture riskCement leakage

Improve:Kyphotic angle

correctionDeployment

predictability10 years of very little innovation in vertebral

augmentation

Until Now: a new implant-based approach

Page 13: Painful VCFs: How and When to Treat Them?

About the Implant-based Approach

Structurally-supportive Implant Stabilize the bone while using less cement Predictable implant structure

Approximates natural bone characteristics Made of medical polymer Provides flexible, structural support

Implanted over removable guidewire, then filled with bone cement

Page 14: Painful VCFs: How and When to Treat Them?

Kiva in Action

Insert Kiva Animation

Page 15: Painful VCFs: How and When to Treat Them?

Impressive Clinical Evidence Supports Implant

In three separate comparative studies, Kiva has been demonstrated to meet or exceed the performance of BKP 1 2 3.  

In one or more of these studies, as compared to BKP, Kiva was shown to:

Reduce rate of adjacent level fractures Improve kyphotic angle restoration Reduce rate of cement leakage into surrounding

tissue Reduce cement volume

1 KAST IDE Study: The Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial2 Otten, Pflugmacher, et al. Pain Physician Journal, October 20133 Korovessis et al. Spine, February 2013

Page 16: Painful VCFs: How and When to Treat Them?

Study Publication Size Results

KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial)

Presented at Society for Interventional Radiology 2014 Scientific Meeting, March 26, 2014

300 patients

Improvement in pain and function were similar to balloon kyphoplasty• Reduced rate of adjacent level

fractures as compared to balloon kyphoplasty - per protocol population*

• Reduced rate of extravasation as compared to balloon kyphoplasty - as reported by Investigators*

• Significant reduction in cement volume over balloon kyphoplasty*

*Posterior probability of superiority was > 90%

Balloon Kyphoplasty versus Kiva Vertebral Augmentation. Comparison of Two Techniques for Osteoporotic Vertebral Body Fractures

SpineFeb. 15, 2013

168 patients

• Significant restoration of the Gardner angle in patients treated with Kiva, whereas ballon kyphoplasty did not meet significance

• Lower extravasation rates with Kiva• Lower cement volume with Kiva VAS,

ODI, and SF-36 were similar

Comparison of Balloon Kyphoplasty with the New Kiva VCF System for the Treatment of Vertebral Compression Fractures

Pain Physician Journal Sept./Oct. 2013

52 patients

• Significantly lower rate of new fractures following treatment with Kiva

• Pain improvement was significantly better with Kiva at 6 months

• Mean cement used was less than half with Kiva

Page 17: Painful VCFs: How and When to Treat Them?

Additional Implications of KAST

Patients in both the Kiva and kyphoplasty group showed substantial improvements over baseline Although Kiva showed distinct advantages

●Patients treated as early as 2 weeks post onset of pain demonstrated marked improvement by 7 days post intervention. 

Page 18: Painful VCFs: How and When to Treat Them?

Kiva Case from KAST

Page 19: Painful VCFs: How and When to Treat Them?

Sample Kiva Case

Courtesy of Wayne Olan, MD, Director of Interventional & Endovascular NeurosurgeryGeorge Washington University Medical Center

Page 20: Painful VCFs: How and When to Treat Them?

Summary: Vertebral Fractures…

Are the most common osteoporotic fractures

Increase the risk of subsequent VCFs by 5-fold and the risk of other fragility fractures (including hip) by 2- to 4-fold

Multiple VCFs: Have similar mortality to hip fractures and so we need

to be vigilant in diagnosis and treatment

Are associated with significant morbidity, even if they do not come to clinical attention

Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Page 21: Painful VCFs: How and When to Treat Them?

Three Takeaways

1. FREE study showed benefits of vertebral augmentation over non-surgical care.

2. New clinically proven, implant-based approach to vertebral augmentation meets or exceeds the performance of BKP.

3. There is clinical evidence showing the benefits of treating acute VCF patients earlier than 6 weeks with vertebral augmentation.

Page 22: Painful VCFs: How and When to Treat Them?

Questions?