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Important Safety Information

Functional Inferior Turbinoplasty (FIT)

This section offers information regarding the clinical efficacy of powered functional inferior turbinoplasty (FIT) using the Medtronic ENT Inferior Turbinate Blade (catalog numbers: 18-82040HR, 18-82040, 18-82940HR, and 18-82940). It will also compare and contrast inferior turbinoplasty using the Inferior Turbinate Blade and several other methods of addressing inferior turbinate hypertrophy. 

Clinical Application, Safety and Efficacy 
The use of the microdebrider in inferior turbinoplasty has been widely described in clinical literature . The functional mucosa-sparing technique for the use of the Medtronic ENT Inferior Turbinate Blade was described, with minor variations, by Sacks et al (2005), O'Halloran (2005), and Friedman (2005). The three studies found inferior turbinoplasty performed with the Medtronic ENT blade to be a safe and effective method of addressing inferior turbinate hypertrophy. In addition, Sacks compared powered submucosal inferior turbinoplasty with the use of the Medtronic ENT Inferior Turbinate Blade to turbinoplasty with the use of electrocautery and to submucosal resection (inferior portion of the turbinate bone removed).

Powered submucosal turbinoplasty vs. electrocautery
Result longevity
In a prospective, randomized, double-blinded study, Sacks examined the objective and subjective outcomes between three different techniques:

• Powered submucosal turbinoplasty with the use of the Medtronic ENT Inferior Turbinate Blade (coded as SPT),
• Submucosal electrocautery (SEC), and
• Submucosal resection with the removal of the inferior portion of the turbinate bone (mucosal flap used to avoid leaving denuded bone surfaces) ("modified endoscopic turbinoplasty," MET).

Patients served as their own controls. The clinical team examined the patients enrolled in Sacks' study 1, 4 and 12 months after the surgery. Study participants were scored postoperatively on a four-point objective scale:

1. Marked congestion – posterior choana not visible with 0 degree endoscope
2. Posterior choana visible with endoscope but with the need for decongestion
3. Posterior choana visible with endoscope without decongestion
4. Posterior choana visible with Lumiview headlight (Welch-Allyn)

While the objective results after one month were comparable across techniques, the results after 4 and 12 months favored MET and SPT, and showed that 56% of sides treated with SEC re-hypertrophied after 12 months (defined as scores of either 1 or 2). For comparison, scores of 1 or 2 at the 12-month follow-up were seen in 12% of the patients treated with MET and 16% patients treated with SPT. Of the two mucosa-sparing techniques, functional inferior turbinoplasty (SPT) was by far superior (p = 0.001) to electrocautery (SEC) at 4 and 12 months.

Most of Sacks' patients perceived subjective improvement, regardless of technique, and the differences in the subjective scores between SEC and SPT did not reach statistical significance. Based on subjective scores, MET was statistically superior. Subjective scales are suspect, however, as illustrated by Nease and Krempl (2004) in a study comparing the effects of electrocautery inferior turbinoplasty (SEC) in treatment and placebo groups. In their study, placebo effect accounted for significant proportions of improvement in all of the measured categories.

Complications
A number of authors have described complications involved in inferior turbinoplasty with different techniques, including Sacks, O'Halloran (functional inferior turbinoplasty, FIT, equivalent to Sacks' SPT), Friedman, and Bhattacharyya.

• Crusting: Postoperative crusting was observed in 56% of the sides treated with the energy-dependent technique, SEC (Sacks). That number is significantly higher than the 2% observed with SPT in the Sacks study and the 5% observed by O'Halloran with FIT (equivalent of Sacks' SPT).

• Pain: 22% of the SEC patients reported pain, compared to 9% of SPT patients as reported by Sacks.

• Bleeding: Sacks reported no bleeding with SEC, and 7% with SPT. None of the subjects required nasal packing or any further intervention. O'Halloran reported bleeding in 1% of his patients treated with powered submucosal turbinoplasty with the use of the Medtronic ENT Inferior Turbinate Blade, and Friedman observed bleeding in 1.6%. In the case of a technique related to SEC, inferior turbinoplasty with the use of a Coblation wand, bleeding complications were reported in two studies by Bhattacharyya (2002 and 2003), and were at 3% and 8.3%, respectively.

Conclusion
Clinical evidence indicates that functional inferior turbinoplasty performed with the Medtronic ENT Inferior Turbinate Blade is a safe and effective method of addressing inferior turbinate hypertrophy.

• FIT offers significantly longer-lasting objective improvement than energy-dependent techniques, such as electrocautery.

• The rates of postoperative bleeding are comparable to other techniques, and the technique has delivered significant benefits by decreasing incidence of postoperative pain and crusting compared to electrocautery.

Please contact your local Medtronic ENT representative if we can assist you in evaluating the Functional Inferior Turbinoplasty technique utilizing the Inferior Turbinate Blade.