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 PresentationTRANSCRIPT
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
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
Similar Mortality in Hip Fracture and VCF Patients
Source: International Osteoporosis Foundation: Vertebral Fracture Initiative
BalancedForceConcentration
ForceTransmission
Biomechanics of Kyphosis: “Kyphosis begets Kyphosis”
VCFs Increase Risk of Subsequent Fragility Fracture
Source: International Osteoporosis Foundation: Vertebral Fracture Initiative
Consequences of Kyphosis
• Deformity
• Debilitation
• Disability
• Depression
• Death
Source: International Osteoporosis Foundation: Vertebral Fracture Initiative
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
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
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.
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.
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
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
Kiva in Action
Insert Kiva Animation
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
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
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.
Kiva Case from KAST
Sample Kiva Case
Courtesy of Wayne Olan, MD, Director of Interventional & Endovascular NeurosurgeryGeorge Washington University Medical Center
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
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.
Questions?