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Update on Sinus Balloon Surgery
This new procedure could dramatically ease the recovery period for sinusitis sufferers.
, Jeffrey Paffrath, David Nicely
Publish Date: October 27, 2008   |  Tags:   ENT

It's tough to pick the most compelling reason for adding sinus balloon surgery. For one thing, more than 37 million Americans suffer from sinusitis, and at least one-quarter of those sufferers are candidates for this procedure, so there's no lack of patients. For another, it's not just minimally invasive, it's minimally damaging: Many patients don't need any pain meds and almost all can return to work the very next day. Finally, there's more financial upside to the sinus balloon treatment than to traditional sinusitis procedures.

Sound good? Well, there are drawbacks:

  • While you may already have some of the capital equipment needed for the procedure in your ORs, you do have to buy the sinus balloon system and disposables.
  • Physicians have to be specially trained to perform the procedure.
  • No large-scale study proving the safety and efficacy of balloon sinuplasty has been done.

When we at StoneCrest Medical Center considered all the factors, we decided the advantages made it worthwhile, and became the first hospital in Tennessee to use balloon technology to treat chronic sinusitis. Here's what you need to know if you're thinking about adding sinus balloon procedures.

Back to school
Before you buy anything, you need to get your surgeons certified to use the balloon technology. The balloon sinuplasty manufacturer holds several courses a year. This training consists of a couple days of hands-on work in a lab, using all the devices on cadavers. It's a three-step procedure:

  • The surgeon introduces a catheter to the sinus using endoscopic visualization. He then gently advances a flexible guide wire through the catheter and into the target sinus using fluoroscopic guidance.
  • The surgeon then tracks a catheter with the sinus balloon over the guide wire, using fluoroscopy to determine its position in the blocked opening. A nurse inflates the balloon, which restructures the ostium by gradually opening it. (No worries about over-inflation: The balloon is calibrated, so the surgeon can pick the pressure he wants it to stop at.)
  • Finally, the surgeon removes the balloon, guide wire and catheter.

Getting a feel for the technique is fairly easy, though it's rare that the wire goes right in; the surgeon has to have a little finesse to adjust to differences in patient anatomy. The learning curve is mostly in the equipment, though. The catheter and balloon devices aren't something ENT surgeons are used to using - they're more similar to the types of equipment used by cardiac surgeons performing angioplasties. In addition, fluoroscopy guidance will be new to your surgeons, who are used to visualizing the sinuses using a telescope. When working with the one-dimensional fluoroscopic images, surgeons have to use landmarks to help them assess position. Plus, the fluoroscopy unit is a bulky machine that takes a little time to learn to work around.

After training, company reps will join each ENT surgeon in the OR and proctor his first 10 procedures to observe, train staff on the device and answer questions that arise.

For optimal outcomes
This technique won't replace standard endoscopic sinus surgery in most cases: Isolated maxillary sinus and phenoidal sinus obstructions require surgeons to go 7cm to 9cm into the nose, and it's difficult to gain the proper access with the balloon. However, it's a helpful tool for at least 25 percent of cases - ethmoidal and maxillosinal patients can benefit - and more than that, if you consider there will be cases where both traditional and balloon techniques can be used, letting you perform more than one procedure per patient.

The Problem Behind the Procedure

  • Sinusitis occurs when the sinuses become obstructed or inflamed, causing them to swell and block proper drainage. Sufferers experience headaches, post-nasal drip, congestion, fatigue, thick green and yellow mucus, and facial pain.
  • The number of chronic sufferers is estimated to be 16 percent of adults - or 37 million people - in the United States.
  • Chronic sinusitis alone results in an estimated 18 to 22 million physician office visits a year.
  • Direct healthcare expenditures due to sinusitis cost are well over $6 billion each year.
  • Total restricted activity days due to sinusitis are well over 73 million per year.

We use general anesthesia, though you could probably perform some of the procedures under sedation. Operative time is about the same, though doing a combination procedure in the frontal sinuses is very efficient. Instead of 30 or 45 minutes per side, depending on how delicate the sinus structures are, it's now about five minutes on each side. And staffing is the same as for traditional sinus surgery.

Because balloon sinuplasty maintains the integrity of the sinus lining and doesn't involve removing bone, packing the sinuses and potential scarring (as conventional sinus surgery does), patients recover faster and with less pain and bleeding. In fact, many of the maxillosinal patients don't require pain medications, which means they're recovered and discharged faster, freeing up your PACU. Further, most sinus balloon patients return to normal activity within 24 hours of surgery - compared to about one week for conventional sinus surgery - and don't have to undergo post-op cleanings at the physician's office.

Financial figures
It's still early, but our average supply costs, including medication, run about $4,000 per procedure; the necessary disposables alone cost about $1,200. That's a bit more than for the traditional procedure, but we're still in the ramp-up phase, and we expect to lower our supply costs once we're doing more of the balloon procedures. The best indication is that CMS assigned a reimbursement code for the devices last summer: HCPCS device code C1726 (catheter, balloon dilatation, non-vascular). Although billing for most device C-codes, including C1726, may not generate immediate additional Medicare payment, it can affect future payment levels as new device costs are identified and included in data used to establish these rates.

Like any new procedure, the techniques, equipment and margins will get better over time for balloon sinuplasty. Large-scale clinical trials are under way, and we expect they will bear out what we've already learned: that the procedure is efficient and effective and that patient satisfaction is high.