Introduction

Welcome to this discussion among spine surgeons treating spinal fracture and lumbar spinal stenosis. This discussion will cover kyphoplasty and X-STOP IPD. Panel Intelligence discussions are enhanced when you, as a panelist, not only respond to the posted questions, but also reply to comments made by our moderator and your fellow panelists. We look forward to a lively and interactive discussion. In your participation on this panel, Panel Intelligence expects and requires that you comply with the terms of the Consultant Confidentiality Agreement to which you previously agreed. If you have any questions about the terms of that agreement, please review them through the link provided on your Panel Intelligence home page after you've logged in.

Section 1: Kyphoplasty

The first half of this discussion will cover spinal fracture and the use of kyphoplasty.

Q1: Current treatment of spine fracture

How do you currently manage patients with spinal fracture? What are the treatment options you consider, and for what patient groups or circumstances?

Panelist 1: for simple compression fractures that are isolated and minimally compressed without ADL limiting pain--bracing/medication: if at least moderate compression and ADL limiting pain, offer option for bracing or Kyphoplasty: if fracture remains painful and/or progresses especially in a critical biomechanical area, then recommend kyphoplasty

Panelist 3: I agree

Panelist 2: isolated compression fractures w/ limited pain and effects on ADL --> bracing; 30-50% compression --> bracing vs kypoplasty progresssion or very painful --> kyphoplasty

Panelist 3: 1-2 months of limiting activities. If that is not working, kyphoplasty or vertebroplasty

Panelist 3: Elderly patients, I try conservative. If ineffective, I consider kypho or vertebroplasty

Panelist 6: Vast majority of patients with compression or burst fractures I will manage nonsurgically with bracing. If they have signficant pain with ADL's, I will often recommend vertebroplasty vs. kyphoplasty. Most importantly, however, I make sure that all patients with such fractures have a DEXA scan and have appropriate treatment for osteopenia/osteoporosis.

Panelist 5: I agree with Panelists 1 & 6. Most such fractures are treated 'medically'. Unreasonable pain, disruption of ADLs for more than a brief period of time, limitations requiring inpatient admission or neurologic deficits are reason for active intervention. If malalignement is not necessary, I vote for v'plasty. K'plasty is reserved for those who I believe need a reduction.

Panelist 7: Patients with spinal fracture first must be determined to have acute fractures. Obviously, we are much less concerned about chronic fracture. Treatment options include bracing and pain management, or kyphoplasty. Frequently, I will give them at least 10 days before we consider kyphoplasty.

Follow-up ALL: Kyphoplasty vs. vertebroplasty

Panelist 5 uses vertebroplasty if malalignement is not necessary and kyphoplasty for those who need a reduction. Do others use these criteria for selecting vertebroplasty versus kyphoplasty? Please explain when you select one procedure versus the other. Some of you do not mention vertebroplasty at all; do you use this procedure, and if so, when and why?

Panelist 6: I find that although kyphoplasty has the theoretical advantage of reducing a fracture, in practice I have not noticed a significant improvement in segmental kyphosis. I do think that kyphoplasty may be a little safer when the posterior vertebral body is fractured as it may lower the risk of cement extravasation.

Panelist 5: I agree with this point about posterior cortical wall violation.

Panelist 1: No. In all cases I like kyphoplasty with the development of a cavity to inject the cement--I feel there is less risk of extravasation with lower injection pressure as well although the current literature is not supportive of this.

Panelist 5: The Kyphon marketing folks and sponsored studies have hit their mark here. In qualified hands, treating osteopenic fractures, these procedures are equally safe and effective for most fractures. There are plenty of k'plasty disasters that are not reported. Someday we'll probably see a 'closed 'claims' analysis that will bear this out.

Panelist 3: I only use kypho if the vertebral body is extremely compressed. I do not believe the balloon in the kypho procedure restores height as much as the company states.

Panelist 2: I have had good experiences with kyphoplasty and use this almost exclusively.

Panelist 7: i dont use kyphoplasty

Panelist 7: sorry-that was an error-- i dont use vertebroplasty

Panelist 1: It depends on the fracture type, degree or stbility of the fracture, level of the fracture, the patient's pain level and control thereof, their body habitus in terms of bracing and comorbidities--options then range from analgesics, bracing and surgery. This is a very broad question.

Panelist 5: I still think that kyphoplasty, when patiently applied, does a better job of restoring alignment. But I remain selective about it's use. Routinely using just one procedure is not my habit.

Click here to review information on kyphoplasty (See Appendix A)

Q2: Vertebroplasty versus kyphoplasty

Please compare and contrast the two procedures: vertebroplasty and kyphoplasty. What are the strengths and weaknesses of each, and when and why would you recommend one versus the other?

Panelist 1: Would always recommend kyphoplasty as there should be less risk of cement extravasation with cavity formed and chance of restored height although an older fracture or significantly compressed one may only allow for a vertebroplasty but still would attempt with kyphoplasty technique

Panelist 2: almost exclusively kyphoplasty. less likely to extrvaasate cement

Panelist 3: kyphoplasty allows reduction of fracture. It is usually done as inpatient because of cost. Vertebroplasty is done as outpatient, and is less expensive. Both are effective for treating osteoporotic fractures.

Follow-up ALL: Cost and inpatient procedures

Panelist 3 reports that kyphoplasty is typically done as an inpatient procedure because of the cost. Do others agree, and how does cost factor into the decision to perform a procedure on an inpatient versus outpatient basis?

Panelist 6: In our hospital both kyphoplasty and vertebroplasty are done as outpatient procedures. Increased cost of kyphoplasty is definitely an issue.

Panelist 1: it doesn't--it depends on whether the pt was admitted with the fracture for pain control prior to consult from our service as to whether it is outpt or inpt rx

Panelist 3: The cost of kypho is too high, and hospitals will give you a problem with the procedure if the patient is done ambulatory.

Follow-up PANELIST 3

Please explain what you mean when you say, “… hospitals will give you problem with the procedure if the patient is done ambulatory.”

Panelist 3: the cost of the kypho kit is too expensive, and hospitals don't get reimbursed enough to for the procedure to be done ambulatory. Otherwise kyphos could be done ambulatory.

Panelist 2: No. We do it as an outpatient in our facility and practice.

Panelist 1: Cost doen't factor in for me-cases done as outpatient unless the patient is already an inpatient and our service was consulted for fracture treatment options.

Panelist 7: dont do vertebroplasty so this is not an issue

Panelist 6: I typically recommend vertebroplasty since it's so much less expensive. I tend to recommend kyphoplasty when there is a higher likelihood of cement extravasation (posterior vertebral body cortex disrupted).

Panelist 5: I side with panelists 3 & 6. At the risk of sounding like a smart ass, the responses of Panelists 1 & 2 are a credit to the Kyphon marketing department. In skilled hands, the procedures are equally safe. Disasters (paraplagia, strioke and death) have occurred with both due to cement extravasation. BUT cost is a very significant differentiating feature. Both are very effective for pain control in the right patients.

Panelist 7: I do not perform vertebroplasty as I do not think that it offers the safety margin that is offered by kyphoplasty. Kyphoplasty's potential negative is cost.

Follow-up ALL: Safety

There is disagreement with regard to the safety of using vertebroplasty versus kyphoplasty. A few of you believe kyphoplasty is safer because of less risk of cement extravasation, while others disagree and report kyphoplasty and vertebroplasty are equally safe. Please explain your position and include the sources of your information regarding safety.

Panelist 6: The risk of cement extravasation is likely lower with kyphoplasty than with vertebroplasty, however, I suspect that clinically significant cement extravasation is low with either procedure.

Panelist 1: I agree the literature does not support this but we have not had any incident of cement leakage with the kyphoplasty.

Panelist 3: Kyphoplasty is slightly safer because you create a space with the balloon and cement is injected under low pressure. In vertebroplasty, the cement is injected under higher pressure, and so you have to be very careful that cement doesn't leak.

Panelist 2: kyphoplasty, with good imaging, and ensuring that the trocar is in the body of the spine ensuresvery little cement extravaation.

Panelist 7: both are safe but recent data does suport a decreased risk of extravasation for kypho compared to vertebro

Follow-up ALL: Cost-benefit comparison

Based on what you know about kyphoplasty and vertebroplasty, please compare the cost-benefit situations for both of these procedures. Which procedure comes out as the winner when looking at the cost-benefit analysis, in your estimation?

Panelist 6: In my mind given the costs associated with kyphoplasty, vertebroplasty is the winner in the majority of cases, although in certain circumstances (posterior vertebral comminution), kyphoplasty is the clear winner.

Panelist 1: Again, I feel the kyphoplasty intuitively offers a better cost -benefit ratio when one considers the ability to restore alignment and prevent flatback symptoms or further compression fxs with better mechanical alignment.

Panelist 3: Vertebroplasty is the winner hands down.

Panelist 2: ky[hoplasty

Panelist 7: there is no doubt cost is more for kyphoplasty but i genuinely would not let one of my family members have a vertebroplasty so therefore only one procedure wins--kypho

Panelist 5: Cost matters to our hospitals and to our national Medicare budget. It's a zero-sum game. We need to be aware of when we can be thrifty. Ours are done as an inpatient, because the patients are usually having general anesthesia, and our outpatient facility does not have two C-arms.

Panelist 5: Aren't those Kyphon marketing guys good?

Panelist 5: A look at the fiscal reality of the two procedure clearly indicates v'plasty as the least expensive by quite a lot of dollars. If and when someone shows real data that supports the long term health and cost benefit of the improved spinal alignment assertion, I will side with k'plasty. Until then, on this point v'plasty wins easily.

Q3: Facilitators and barriers of kyphoplasty

Currently, what are the greatest facilitators for the use of kyphoplasty? What barriers limit the use of kyphoplasty?

Panelist 1: greatest facilitator is good imaging--no real barriers except lack of good quality imaging or significant medical comorbidities

Follow-up PANELIST 1: Comborbidities

Panelist 1, you mention significant medical comorbidities are a barrier limiting the use of kyphoplasty. Please provide more detail, explaining what comorbidities prevent the use of kyphoplasty and how frequent this occurs.

Panelist 1: Pts with mechanical heart valves and pts with brittle diabetes with PVD---both risky in terms of stopping anticougulation in the first place to limit risk of epidural bleed at the cost of TIA/CVA and risks of potential seeding for infection of these brittle diabetics with significant PVD and potential for skin breakdown with decreased mobility due to their neuropathies and fractuer pain pre procedure.

Panelist 3: In my opinion medical comorbidities are no more of a barrier for kypho than for other procedures.

Panelist 2: infrequentyl, neurologic symptoms

Panelist 2: need big suite for procedure. imaging is key. hospital acceptance and interventional radiology turf war is a barrier

Follow-up ALL: Interventional turf war

Panelist 2 lists interventional radiology turf war as a barrier to kyphoplasty. Do others agree, and if so, please explain what this means and how specifically this limits the use of kyphoplasty?

Panelist 6: In our hospital most vertebroplasties and kyphoplasties are done by interventional radiology. Most spine surgeons don't bother with procedure given the low reimbursement.

Follow-up ALL: IRs or Surgeons

Panelist 6 reports most vertebroplasties and kyphoplasties are done by interventional radiology. Is this the case in your institution? What is the approximate breakdown of the number of procedures IRs perform versus surgeons?

Panelist 1: IR does not do any in our institutions.

Panelist 2: probably 60% ortho, 40% IR

Panelist 3: no. it is about 50/50

Panelist 1: All cases done by surgeons, not IRs in our institutions

Panelist 7: our interventionalists are not doing kyphoplasty--they are only doing vertebroplasty

Panelist 5: I agree. We have recently seen a turf squabble between I.R. and I.N.R. ove this stuff. Go figure! Fighting over table scraps?

Panelist 1: This has never been an issue--one should be able to handle their own iatrogenic complications

Panelist 3: This is not a problem for me

Panelist 2: as above

Follow-up PANELIST 2

Please explain what the interventional radiology turf war is, is it between IRs and surgeons? What is the result of this conflict?

Panelist 2: The turf war is between IR and Ortho. The patient usually is treated by whomever sees them first.

Panelist 3: for me it is not an issue

Panelist 5: Strangely enough, we have actually had an aggressive battle in our institution between INR and general IR. Go figure? Fighting over table scraps? There are also procedures of both types done by spine surgeons and our spine non-op PM & R specialists.

Panelist 7: i am not sure what this is--ask panelist 2

Panelist 7: I am not certain what this means--ask panel #2

Panelist 3: cost is biggest problem.

Panelist 6: Costs involved with kyphoplasty.

Panelist 5: Kyphoplasty costs more, takes longer and generally requires more physician 'work' since we do these as inpatients. Thus the doc works for for the same revenue. V'plasty: >95% outpatient, cheaper, faster, less 'preop work'. But only passive reduction is possible.

Panelist 7: Cost is a potential barrier, although almost all carriers are now paying. Greatest facilitator for use is patients who have previously had procedure done, as nearly 95% are happy.

Follow-up ALL: Trends

What trends in the current facilitators and barriers do you expect in the next 1-3 years, and what new influencers do you anticipate will affect the number of kyphoplasties performed?

Panelist 6: Increased costs compared to vertebroplasty and decreasing reimbursements are the barriers to kyphoplasty.

Panelist 1: trends will continue up for a few yrs with better recognition of these treatment options for fxs but better rx of osteoporosis such as once yearly infusions may reduce fx rates even as the popuation ages

Panelist 3: more competition for kyphoplasty

Panelist 2: aas the technology beomces more pervasive nad more clinical evidence is presented, the technology and proced