Surgical Management of Sinusitis (What About Balloons?) Relative Indications for Sinus Surgery in Children

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Surgical Management of Sinusitis (What About Balloons?) Andrew N. Goldberg M.D. Andrew H. Murr M.D. Michael J. Cunningham, M.D. Department of Otolaryngology and Communication Enhancement Children s Hospital Boston Definitive Indications for Sinus Surgery in Children Acute or chronic rhinosinusitis with periorbital or intracranial complications Symptomatic mucoceles of the sphenoethmoid sinuses Systemic co-morbid disease with CT confirmed rhinosinusitis exacerbations Asthma / Cystic fibrosis / Immunodeficiency / Severe allergy / Ciliary dyskinesia Relative Indications for Sinus Surgery in Children Chronic headache and sinus pressure manifestations with CT documentation of sinonasal disease Recurrent sinusitis with CT confirmation of both sinus disease and an anatomic predisposition Chronic recurrent sinusitis of greater than 6 months duration refractory to comprehensive medical therapy without an anatomic predisposition 1

Surgical Management Options Adenoidectomy alone Maxillary sinus lavage Endoscopic sinus surgery Balloon catheter sinuplasty Chronic Recurrent Rhinosinusitis Adenoid hypertrophy or infection (adenoiditis) may adversely affect sinonasal pathology Obstruction (stasis) Interference with mucociliary transport Adenoidectomy Reservoir of bacterial infection (biofilms) Adenoidectomy Removal of nasopharyngeal obstruction No established relationship to adenoid size (Bercin et al. Ann Otol Rhinol Laryngol 2007) Removal of a bacterial reservoir Sinonasal symptoms correlate with quantity of adenoid bacterial colonization (Lee and Rosenfeld. OHNS 1997 / Shin et al. Int J Ped ORL 2008) Adenoid cultures and lateral nasal wall cultures grow identical pathogens (Bernstein et al. OHNS 2001) Adenoid in children with CRS biofilm-covered in contrast to those with OAH (Coticchia et al. OHNS 2007) 2

Adenoidectomy + Maxillary Lavage Adenoidectomy alone has a clinically significant benefit in 60-70% of children with rhinosinusitis (SE Brietzke, MT Brigger. IJPO 2008) (HH Ramadan. JL Cost. Laryngoscope 2008) When combined with maxillary sinus lavage, the incidence of symptomatic improvement approximates 90% (HH Ramadan, JL Cost. Laryngoscope 2008) Chronic Recurrent Rhinosinusitis Maxillary sinus aspiration and irrigation (with or without adenoidectomy) Allows culture-directed oral or intravenous antibiotic therapy Surgical approaches: Maxillary Sinus Lavage Inferior nasal floor (classic sinus tap) Middle meatus via endoscopic antrotomy Middle meatus via balloon catheter sinuplasty Pediatric Conceptual Rationale The osteomeatal complex region is the key to chronic recurrent paranasal sinus disease Improving paranasal sinus ventilation and drainage by the most minimally invasive technique is the surgical goal Extent of Surgery is Disease Dependent Middle meatal antrostomy and limited anterior ethmoidectomy (mini FESS) Complete anteroposterior ethmoidectomy Sphenoidotomy (sphenoethmoidectomy)* Frontoethmoidectomy* Planned periorbital or intracranial extension* 3

Extent of Surgery Perioperative Decisions Need for intraoperative imaging guidance* Need for concurrent septoplasty or turbinate reduction surgery Need for powered instrumentation or balloon sinuplasty equipment Availability of ophthalmologic or neurosurgical intraoperative consultation Preoperative consultation with adult rhinology colleagues General anesthesia with cuffed tube (leak 15-18 mm H 2 0) Nasopharyngeal / oropharyngeal pack Eye ointment Patient positioning Coronal and axial CT scans available Intraoperative image guidance if revision, for complication, or sphenoid/frontal Topical decongestant/vasoconstrictor on neurosurgical cottonoids Oxymetazoline 0.05% Cocaine 4% (3-4 mg/kg maximum) Local injection with 0.5% lidocaine (3mg/kg max dose) with 1/200,000 epinephrine into uncinate region, root of middle turbinate and polyps if present 2.7 mm endoscope used for diagnostic exam if need be 4.0 mm endoscope used for operative intervention if possible Most work done with 0 degree endoscope 30 degree endoscope used for maxillary antrum and frontal recess regions 4

Standard instrumentation need pediatric appropriate sizes Powered instrumentation ideal for extensive mucosal hypertrophy and polyp disease Balloon dilation instrumentation a potential option in specific clinical scenarios Adjuvant Procedures Concurrent adenoidectomy if not previously performed? Upper age limit? Concurrent endoscopic septoplasty if need be for access? Lower age limit? Turbinate hypertrophy management? Middle turbinate reduction / resection Inferior turbinate mucosal & submucosal reduction and ablation techniques Perioperative systemic antibiotics Cleocin T Gel or Bactroban topically into osteomeatal cavities at completion Lidex (0.05% fluocinonide) gel if polyposis or granulation tissue Perioperative systemic steroids (1 mg/kg/day prednisone) if polyposis, cystic fibrosis or severe atopy Rolled Gelfilm between middle turbinate and lateral nasal wall into ethmoid cavity Absorbable hemostatic agent alternatives Surgi-flo/thrombin Fibrin glue Hyaluronic acid Rarely intranasal packing that needs to be removed 5

Is there an adverse effect on facial skeletal maturation? Relevant histopathology Cartilage and woven bone / Lamellar bone Role of periosteal disruption Clinical assessment Prospective randomized animal studies CT analysis and facial photography in unilateral endoscopic surgery patients* 10 year follow-up of 46 children s/p ESS vs. age-matched control group of non-operated children with chronic RS** *B Senior et al. Laryngoscope 2000 **M Bothwell et al. OHNS 2002 Clinical Outcomes ESS results in a clinically significant decrease in: Cough Nasal obstruction Rhinorrhea Headache Visits to doctor s office Overall quality of life* Successful reduction of symptoms without need for further surgery 80-90% Major complication rate < 1% DL Walner et al. Am J Rhinology 2002 RL Hebert and JP Bent. Laryngoscope 1998 Cunningham et al. Arch Otolaryn Head Neck Surg 2000 Limitation of ESS in younger children Decreased efficacy in reducing symptoms of younger children (HH Ramadan. Arch OHNS 2003) Not efficacious in children < 3yrs old 73% efficacy in children < 6yrs old 89% efficacy in children > 6yrs old Increased risk of adhesions and recurrence in younger children (AA El Sharkawy et al. Eur Arch Otorhinolaryngol 2011) Adhesions 57% incidence children < 5yrs old < 15% incidence in children > 5yrs old Recurrence 28% recurrence in children < 5yrs old 10% in children > 5yrs old Balloon Catheter Sinuplasty (BCS) An alternative modality for enlarging the natural sinus ostia via balloon dilation Proposed advantages Theoretically spares the natural mucosa as no tissue removal is required Preservation of normal ciliary function Prevention of postoperative scarring Potential disadvantages Limited to use in the maxillary, sphenoid and frontal sinuses Additional cost of balloon and requisite equipment Its long term effectiveness remains to be determined 6

Balloon Catheter Sinuplasty Endoscopic placement of a guide wire through the natural sinus ostium External illumination confirms guide wire positioning within the maxillary and frontal sinuses Balloon Catheter Sinuplasty Deflated balloon is passed over guide wire, positioned across the natural ostium, and inflated to 5-7mm atmospheric pressure Following dilation, the sinus may be irrigated through a subsequently passed catheter Such confirmation is not possible in the sphenoid sinus Pediatric Balloon Catheter Sinuplasty Evidence No direct comparative studies of BCS versus ESS in children (only one adult study fulfilled Cochrane review RCT criteria)* *Otolaryngol Head Neck Surg 145: 371-374, 2011 One cohort of children retrospectively studied for safety, feasibility and efficacy but confounded by several variables: Concurrent use of adjuvant procedures ESS or adenoidectomy No randomization when different techniques compared Pediatric Balloon Catheter Sinuplasty Safety and Feasibility Safety Illuminated guide wires have eliminated need for fluoroscopy No major complications reported in the pediatric literature to date Feasibility* 30 children 4 16 years of age Over 90% (51/60) of sinuses were cannulated [48 maxillary / 6 sphenoid / 2 frontal] Limited feasibility in hypoplastic maxillary sinuses (6/10) *HH Ramadan Ann Otol Rhinol Laryng 2009 7

Pediatric Balloon Catheter Sinuplasty Efficacy In a cohort of 32 children [2-11 years of age]* 87% experienced a significant decrease in sinonasal symptoms (SN-5 questionnaire at 52 weeks) Confounding factor: 15 of these children also had an adenoidectomy or endoscopic ethmoidectomy Compared to adenoidectomy** Non-randomized 80% reduction of symptoms for BCS + adenoidectomy versus 53% for adenoidectomy alone (60-70% in other studies) 80% efficacy of BCS + adenoidectomy similar to that previously reported for adenoidectomy + maxillary sinus lavage (90%)^ *HH Ramadan et al. Am J Rhinol Allergy 2010 **HH Ramadan, AM Terrell. Ann Otol Rhinol Laryngol 2010 ^HH Ramadan, JL Cost. Laryngoscope 2008 Pediatric Balloon Catheter Sinuplasty Summary Safe and feasible Over 90% of sinuses can be cannulated Limited feasibility in hypoplastic sinuses (60%) No complications reported in the pediatric literature to date ( principally maxillary sinus data) Effective as an adjunctive tool 80 to 87% success in reducing sinonasal symptoms in conjunction with other sinus surgical intervention Caveat: all studies to date from the same investigator with the same patient cohort A Sedaghat & M Cunningham. Laryngoscope Oct 2011 Pediatric Balloon Catheter Sinuplasty Potential Roles of BCS Isolated maxillary sinus disease Isolated sphenoid sinus disease Isolated or concurrent frontal sinus disease Alternative means of maxillary sinus access for sinus lavage with or without adenoidectomy (?) Hard to justify cost effectiveness when endoscopic ethmoid sinus surgery also needed Severe maxillary sinus hypoplasia Antrochoanal polyp Frontal sinus pathology Refractory RS despite previous endoscopic surgery Problematic Patients 8

Inferior Turbinate Reduction Goal is to improve nasal airflow and maintain humidification function via destruction of erectile venous sinusoids but preservation of respiratory mucosa* Common techniques Monopolar electrosurgical reduction Microdebrider mucosal / submucosal resection Radiofrequency submucosal volumetric tissue reduction with bipolar (Coblation / Celeon) or monopolar (Somnoplasty) devices Submucosal resection of turbinate bone *K Kakarala et al. Laryngoscope 2012 Perioperative Management To stent or not to stent? Doubtful role for any non-absorbable stent in children Debatable role for absorbable stents Alternative measures to limit scarring (e.g. mitomycin C) Is a second look nasal endoscopy necessary? Second anesthetic and cost concerns No effect on subsequent revision surgery rates Perhaps indicated in special populations such as very young children? Postoperative Management Oral antibiotic (short term) / nasal steroid spray and nasal saline irrigations (long term) Systemic steroids in severely atopic or CF patients Office examination ideally within 14 21 days Continue systemic allergy / asthma / CF management Follow-up 6 weeks / 6 months / 1 year thereafter Outcomes Objective Criteria Symptom resolution Improvement in CT findings Decreased medication requirements No need for revision surgery Disease free Subjective Criteria Surgery met or exceeded expectations Patient / family satisfaction Improvement in quality of life Cured 9

Is There a Role for the Balloon in Pediatric Sinus Surgery? 1. Ahmad RS, Cunningham, MJ. Does balloon catheter sinuplasty have a role in the surgical management of pediatric sinus disease? Laryngoscope 2011. 2. Batra PS, Ryan MW, Sindwani R, Marple BF. Balloon catheter technology in rhinology: Reviewing the evidence. Laryngoscope 2011; 121: 226-232. 3. Stewart AE, Vaughan WC. Balloon sinuplasty versus surgical management of chronic rhinosinusitis. Curr Allergy Asthma Rep 2010; 10: 181-187. 4. Ramadan HH. Safety and feasibility of balloon sinuplasty for treatment of chronic rhinosinusitis in children. Ann Otol Rhinol Laryngol 2009; 118: 161-165. 5. Ramadan HH, McLaughlin K, Josephson G, Rimell F, Bent J, Parikh SR. Balloon catheter sinuplasty in young children. Am J Rhinol Allergy 2010; 24: e54-56. 6. Ramadan HH, Terrell AM. Balloon catheter sinuplasty and adenoidectomy in children with chronic rhinosinusitis. Ann Otol Rhinol Laryngol 2010; 119: 578-582. 7. Ramadan HH, Cost JL. Outcome of adenoidectomy versus adenoidectomy with maxillary sinus wash for chronic rhinosinusitis in children. Laryngoscope 2008; 118: 871-873.