1. Background Results Conclusion
Safe and effective treatment of ethmoid sinusitis utilizing minimally invasive ethmoid punch (EP) sinusotomy in CRSsNP patients
Nathalia Velasquez MD; Andrew Thamboo MD; Waleed M. Abuzeid, MD, and Jayakar V. Nayak MD, PhD
Department of Otolaryngology – Head and Neck Surgery at Stanford University School of Medicine, Stanford, CA
Background
Current rhinologic practice lacks minimally invasive procedures to treat ethmoid sinusitis to improve ventilation and topical drug delivery.
We have presented data on use of a handheld spiral punch (Figure 1) to create minimally invasive ethmoid punch (EP) sinusotomies into both the ethmoid bulla and basal lamella. In cadaver models, this significantly increases irrigant delivery to the ethmoid sinuses.
The objective of this prospective study was to evaluate the minimally invasive EP sinusotomy approach in CRS without nasal polyps (CRSsNP) patients with active ethmoid disease following failed maximal medical therapy.
Results
30 of 40 possible ethmoid compartments (17/20 anterior, 13/20 posterior) underwent EP sinusotomy.
Primary outcomes:
SNOT-22 scores significantly improved with a mean reduction of 33.1 (49.6±7.5 pre-EP vs 16.5±7.7 post-EP, p=0.0001)
Ethmoid sinus cavities with pre-procedure LM scores of 1 or 2 universally improved to LM score of 0 following EP sinusotomy (n=32, 100%) (Table 1).
31/32 ethmoid compartments with baseline LM score of 1-2 improved to LM score of 0 (n=31, 96.8%) and those with baseline LM score of 0 showed no worsening at 24 weeks of follow up (n=8, 100%) (Figure 3).
Secondary outcomes:
Technical success was 100%, average opening achieved was 4.8mm.
No device-related/procedure-related complications or adverse events reported
29/30 EP sinusotomy sites remained patent (n=29, 96.6%)
9 punch sites became stenosed (n=9, 30%) with 1 completely closing off (n=1, 3.33%).
All patent punch sites had complete remucosalization (n=29, 100%) with no evidence of recirculation (n=29, 100%).
Protective sheath over
spiral cutter
Wheel to advance spiral
into tissue
Trigger for 4mm
circular punch
RELIEVA CIRCA™
Figure 1
Table 1. Primary outcomes: Mean SNOT-22 and Lund-Mackay scores for all patients at baseline and specific time points.
All subjects
Intrapatient change
SNOT-22
Time point
Mean (SD)
Change from baseline, mean p
Baseline
49.6 (7.5)
---
1 week
40.4 (14.5)
-9.2*
0.092
4 weeks
28.1 (7.4)
-21.5*
<0.0001
12 weeks
17.3 (8.1)
-31.5*
24 weeks
16.5 (7.7)
-33.1*
Lund-Mackay Score P 8
24 week
0.7
-7.3
Patients and Methods
Design:
Single arm, CRSsNP patients with at least maxillary and ethmoid disease who failed medical management and were surgical candidates
Consecutive patients meeting above criteria were offered the option of EP plus maxillary balloon sinuplasty in lieu of standard ESS (Figure 2)
Primary outcomes:
SNOT22: Baseline, 1, 4, 12 and 24 weeks POP
Lund-Mackay score: Baseline and 24 weeks POP
Secondary outcomes:
Technical success, safety, effectiveness, EP site characteristics (patency, remucosalization), complications (closure, recirculation) were assessed.
Analysis:
Student’s t-test was used to compare continuous variables, and p<0.05 was considered statistically significant.
SD= standard deviation; SNOT-22= 22-item Sino-Nasal Outcome test
* Clinically significant improvement (>-8.9) B A
Figure 3: Radiologic evidence of ethmoid disease improvement after EP sinusotomy. (A) Baseline (B) 24 weeks after procedure.
Figure 2 A B EB
Right Middle Meatus following EP sinusotomy U MT
Intra-op Right Middle Meatus
Conclusion
EP sinusotomy represents a promising evolution in the development of minimally invasive rhinologic procedures.
With EP sinusotomy, the surgeon can safely and effectively access both the anterior and posterior ethmoid sinuses in the office/OR with minimal disruption of local tissue integrity for the treatment of ethmoid sinusitis in CRSsNP patients refractory to medical therapy.
The EP appears to represent a compelling bridge technology between maximal medical therapy and ESS for ethmoid sinusitis, and an attractive addition to hybrid surgical platforms for both the office and OR.
References:
1. Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, Vital and health statistics. Series 10, Data from the National Health Survey. Jan 2012(252):1-207.
2.Rudmik L, Smith TL. Quality of life in patients with chronic rhinosinusitis. Current allergy and asthma reports. Jun 2011; 11(3):
3. Catalano PJ, Strouch M. The minimally invasive sinus technique: theory and practice. Otolaryngologic clinics of North America. Apr 2004; 37(2): , viii.
4. Stankiewicz J, Tami T, Truitt T, Atkins J, Liepert D, Winegar B. Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia. American journal of rhinology & allergy. May-Jun 2009; 23(3):
5. Chiu AG, Kennedy DW. Disadvantages of minimal techniques for surgical management of chronic rhinosinusitis. Current opinion in otolaryngology & head and neck surgery. Feb 2004; 12(1):38-42.
6. Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP.Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34: 447–454.