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Implantable Sinus Stents and Drug-Eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease

Policy Number: MP-501

Latest Review Date: March 2019

Category:  Medical/Surgical 

Policy Grade:  A

Description of Procedure or Service:

Steroid-eluting sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS) or for treatment of recurrent sinonasal polyposis following ESS. These devices maintain patency of the sinus openings in the postoperative period, and/or serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery and/or reduce the need for additional surgery.

Chronic Rhinosinusitis

Chronic rhinosinusitis is an inflammatory sinus condition that has prevalence between 1% and 5% in the U.S. population.

Treatment

Endoscopic sinus surgery (ESS) is typically performed in patients with chronic rhinosinusitis unresponsive to conservative treatment. The surgery is associated with improvements in symptoms in up to 90% of more appropriately selected patients. However, there are no high-quality RCTS comparing functional ESS to continued medical management or alternative treatment approaches. Because of the high success rates and minimally invasive approach, these procedures have rapidly increased in frequency, with an estimated 250,000 procedures performed annually in the U.S. They can be done either in the physician’s office under local anesthesia or in the hospital setting under general anesthesia.

ESS involves the removal of small pieces of bone, polyps, and debridement of tissue within the sinus cavities. There are a number of variations on the specific approach, depending on the disorders that are being treated and the preferences of the treating surgeon. For all procedures, there is a substantial amount of postoperative inflammation and swelling, and postoperative care is therefore a crucial component of ESS.

There are a number of postoperative treatment regimens, and the optimal regimen is not certain. Options include saline irrigation, nasal packs, topical steroids, systemic steroids, topical decongestants, oral antibiotics, and/or sinus cavity debridement. There have been a number of randomized controlled trials (RCTs) that have evaluated various treatment options, but all different strategies have not been rigorously evaluated. A systematic review evaluated the evidence for these therapies. The authors of this review concluded that the evidence was not strong for any of these treatments but that some clinical trial evidence supported improvements in outcomes. The strongest evidence supported use of nasal saline irrigation, topical nasal steroid spray, and sinus cavity debridement.

Some form of sinus packing is generally performed postoperatively. Simple dressings moistened with saline can be inserted manually following surgery. Foam dressings are polysaccharide substances that form a gel when hydrated and can be used as nasal packs for a variety of indications. Middle meatal spacers are splint-like devices that prop open the sinus cavities post-ESS, but are not designed for drug delivery. There is some RCT evidence that middle meatal spacers may reduce the formation of synechiae following ESS, although the available studies have significant heterogeneity in this outcome.

Implantable Sinus Stents

Implantable sinus stents are another option for postoperative management following ESS. These implants are intended to stabilize the sinus openings and the turbinates, reduce edema, and/or prevent obstruction by adhesions. They also have the capability of being infused with medication that can be delivered topically over an extended period of time, and this local delivery of medications may be superior to topical application in the postoperative setting.

Sinus stents are defined as implantable devices that are specifically designed to improve patency and/or deliver local medication. These devices are inserted under endoscopic guidance and are distinguished from sinus packing and variations on packing devices that are routinely employed post sinus surgery.

Foam dressings, such as SinuFoam™, are used as nasal packs for a variety of conditions, including nosebleeds, and have also been used post-ESS. These are considered different types of nasal packing.

Middle meatal spacers are related but separate devices that are intended to maintain sinus patency post-ESS. They are splint-like devices that are inserted directly rather than under endoscopic guidance, and they do not have the capability of delivering local medication.

SINUVA

Placed during a routine physician office visit, Sinuva (mometasone furoate) expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days. Sinuva may be an alternative to surgery and other treatment options for adults who have already had ethmoid sinus surgery. Sinuva is marketed to shrink nasal polyps and reduce nasal obstruction and congestion.

Policy:

The use of implantable nasal/sinus stents or drug-eluting implants are considered not medically necessary and investigational for the following, including, but not limited to:

  • postoperative treatment following endoscopic sinus surgery;

  • for treatment of recurrent sinonasal polyposis.

Key Points:

The most recent literature search was performed through December 04, 2018. The following is a summary of the key findings to date.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Randomized controlled trials (RCTs) are important in the evaluation of sinus implants as an adjunct to endoscopic sinus surgery to adequately compare implantable stents to alternative treatment regimens and to minimize the effects of confounders on outcomes. Case series and trials without control groups offer little in the way of relevant evidence, as improvement in symptoms is expected after endoscopic sinus surgery (ESS) and because there are multiple clinical and treatment variables which may confound outcomes.

Steroid-Eluting Stents as an Adjunct to Endoscopic Sinus Surgery

Clinical Context and Therapy Purpose

The purpose of a steroid-eluting sinus stent in patients who have chronic rhinosinusitis who have endoscopic sinus surgery is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: does the adjunctive use of a steroid-eluting sinus stent improve the net health outcome in patients who have endoscopic sinus surgery?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population(s) of interest are patients who have endoscopic sinus surgery for chronic rhinosinusitis.

Interventions

The therapy being considered is a bioabsorbable steroid-eluting sinus stent (e.g., PROPEL Sinus Stent, PROPEL mini Sinus Stent, PROPEL Countour Sinus Stent) for post-operative care following ESS.

Comparators

The most relevant comparison for sinus stents is unclear because there is no standardized optimal postoperative treatment regimen. Ideally, the “standard care” comparison group should include some form of packing, intranasal steroids, and irrigation. An important consideration in evaluating controlled trials is that the control arm may not be treated with optimal intensity, thereby leading to a bias in favor of the device. For example, a study design that compares a steroid-eluting stent with a non-steroid-eluting stent will primarily evaluate the efficacy of steroids when delivered by the device, but will not evaluate the efficacy of a stent itself. If the control group does not receive topical or oral steroids postoperatively, then this might constitute under treatment in the control group and result in a bias favoring the treatment group. Another concern is comparison of the efficacy of a drug with the efficacy of a drug delivery system. For example, if a steroid-eluting spacer is compared with a control of saline irrigation alone, it will be difficult to separate the efficacy of the drug itself (steroids) from the drug delivery system (stent).

Outcomes

The Perioperative Sinus Endoscopy score sums the combined scores determined from middle turbinate position, middle meatal status, ethmoid cavity appearance, as well as secondary sinus blockage (frontal and sphenoid). Each category is scored from 0-2, with 0 being not present, 1 as partially present, and 2 being fully present. The highest total score is 16, with scores ranging from 18-20 when the frontal and sphenoid sinuses are also included. The higher the score, the worse the status of the nasal cavity.

Post-ESS synechiae formation, the Sino-Nasal Outcome Test (SNOT-22) Questionnaire and the Rhinosinusitis Disability Index may also be used to evaluate perioperative outcomes.

A beneficial outcome would be an improvement in symptoms.

A harmful outcome would be adverse events from the implantable stents.

Timing

The PROPEL series of sinus stents are bioabsorbable and elute steroids for 30 days. Therefore, outcomes should be assessed within 30 days.

Setting

The setting is treatment by an otolaryngologist in a surgical center.

Review of Evidence

The literature consists of randomized trials, single-arm case series, and systematic reviews of these studies. The following is a summary of the key findings to date.

Systematic Reviews

A 2015 Cochrane review addressed steroid-eluting sinus stents for improving chronic rhinosinusitis symptoms in individuals undergoing ESS. Study eligibility criteria were RCTs that studied the effects of steroid-eluting sinus stents compared with non-steroid-eluting sinus stents, nasal packing, or no treatment in adults with chronic rhinosinusitis who underwent ESS. After an initial search, 21 RCTs were identified, including the RCTs reported by Murr et al (2011) and Marple et al (2012) described above. None of the studies met the authors’ inclusion criteria. The authors conclude that there is no evidence from high quality RCTs to demonstrate the benefits of steroid-eluting stents.

Randomized Controlled Trials

RCTs are shown in Tables 1 and 2. There are 4 RCTs of the PROPEL, PROPEL mini, and PROPEL Contour steroid-eluting sinus stents, all sponsored by the device manufacturer (Intersect ENT).These trials used an intrapatient control design, with each patient receiving a drug-eluting stent on 1 side and a non-drug-eluting stent or medical treatment on the other via random assignment.

The two trials of PROPEL for the ethmoid sinus had similar designs. Both compared an implant that is steroid-eluting with an identical non-steroid-eluting implant. Thus these trials tested the value of drug delivery via a stent, but did not test the value of a stent itself vs treatment without a stent. The primary efficacy outcome in Murr et al was degree of inflammation rated by the treating physician. In Marple et al the primary outcome was reduction in the need for postoperative interventions at day 30 post procedure. A panel of 3 independent experts, blinded to treatment assignment and clinical information, viewed the endoscopic results and determined whether an intervention was indicated. The need for postoperative intervention by expert judgment was found in 33.3% of patients in the steroid-eluting arm and in 46.9% in the non-steroid-eluting arm (p=0.028). The reduction in interventions was primarily driven by a 52% reduction in lysis of adhesions (p=0.005). The primary safety hypothesis was met, because there were no cases of clinically significant increases in ocular pressure recorded over the 90-day period post procedure.

The RCTs by Smith et al (2016) and Luong et al (2017), implanted either a PROPEL Mini Sinus Implant or a PROPEL Contour Sinus Implant in the frontal sinus with a control of surgery alone on the contralateral side. The primary outcome was the need for post-operative intervention (e.g., surgery or steroids) determined by an independent blinded physician. Both trials showed a reduction in the need for additional surgical intervention by approximately 22%, with no adverse effects of treatment. The number needed to treat was 4.7 to prevent 1 patient from undergoing postoperative intervention. No stent-related adverse events were noted.

Table 1. Summary of Key RCT Characteristics

Study; Trial

Countries

Sites

Dates

Participants

Interventions

Active

Comparator

Murr et al (2011).

38 patients with refractory CRS

Unilateral PROPEL steroid-eluting stent in the ethmoid sinus

Non-drug-eluting stent on the other contralateral side

Marple et al (2012)(ADVANCE II)

105 patients with refractory CRS

Unilateral PROPEL steroid-eluting stent in the ethmoid sinus

Non-drug-eluting stent on the contralateral side

Smith et al (2016)

US

11

80 patients with CRS who were scheduled to undergo primary or revision bilateral frontal sinusotomy

Unilateral PROPEL Mini Sinus Implant in the frontal sinus

Surgery alone on the contralateral side

Luong et al (2017)

US

12

80 patients with CRS who were scheduled to undergo primary or revision bilateral frontal sinusotomy

Unilateral PROPEL Contour Sinus Implant in the frontal sinus

Surgery alone on the contralateral side

CRS: chronic rhinosinusitis; RCT: randomized controlled trial.

Table 2. Summary of Key RCT Results

Study

Primary Outcome Measure

Polypoid Changes

Adhesions/scarring

Implant-Related Adverse Events

Murr et al (2011).

Degree of Inflammation at 21 Days Post-Procedure (100 mm VAS)

N

37

37

PROPEL steroid-eluting Stent

18.4%

5.3%

Non-steroid-eluting stent

36.8%

21.1%

Diff

18 points

p-value

NR

0.039

0.03

Marple et al (2012)

Need for Post-Operative Intervention Determined by 3 Independent Reviewers

N

91

PROPEL steroid-eluting Stent

33.3%

Non-steroid-eluting stent

46.9%

Diff

13.6%

p-value

0.028

Smith et al (2016)

Need for Post-Operative Intervention at 30 Days (Independent Reviewer) n (%)

Need for Post-Operative Intervention at 90 Days

Occlusion/ Restenosis Rate at Day 30

N

67 (adequate video for independent review)

79

PROPEL mini-sinus steroid-eluting stent

26 (38.8%)

16 (21.1%)

none

SOC without a stent

42 (62.7%)

35 (46.1%)

p-value

0.007

0.013

0.023

<0.001

Luong et al (2017)

Need for Post-Operative Intervention at 30 Days (Independent Reviewer) n (%)

Need for Surgical Intervention at 30 Days (Independent Reviewer) n (%)

Occlusion/ Restenosis Rate at Day 90

N

61

58

69

PROPEL Contour steroid-eluting stent

7 (11.5)

4 (6.9)

16 (23.2)

SOC without a stent

20 (32.8)

15 (25.9)

28 (40.6)

Diff (95% CI)

21.3% (35.1% to 7.6%)

19.0% (32.8% to 5.1%)

−17.4% (−28.6% to −6.1%)

NNT

4.7

Summary

Range 13.6% to 23.9%

CI: confidence interval; HR: hazard ratio; NNT: number needed to treat; NR: not reported; RCT: randomized controlled trial; SOC: standard of care.

Gaps in relevance and in design and conduct are shown in Tables 3 and 4. The primary gap for the Studies by Murr et al (2011) and Marple et al (2012) on the PROPEL implant in the ethmoid sinus was whether the comparator had received the optimal treatment in terms of packing, intranasal steroids, and irrigation. For the studies by Smith et al (2016) and Luong et al (2017), there was a high percentage of patients who were not able to be evaluated due to video quality.

Table 3. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

Follow-Upe

Murr et al (2011).

3. The comparator may not have received the optimal treatment (some form of packing, intranasal steroids, and irrigation)

Marple et al (2012)

3. The comparator may not have received the optimal treatment (some form of packing, intranasal steroids, and irrigation)

Smith et al (2016)

Luong et al (2017)

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. the intervention of interest.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 4. Study Design and Conduct Gaps

Study

Allocationa

Blindingb

Selective Reportingc

Data Completenessd

Powere

Statisticalf

Murr et al (2011)

3. Outcome assessed by treating physician

Marple et al (2012)

Smith et al (2016)

2. Incomplete reporting of secondary outcomes

1. 12 (17%) patients did not have independent review at 30 days due to suboptimal video quality.

Luong et al (2017)

1. 19 (24%) patients did not have independent review at 30 days due to suboptimal video quality.

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Nonrandomized Comparative Studies

The largest nonrandomized study identified was reported by Xu et al in 2015, which evaluated post-ESS synechiae formation among 146 patients (252 nasal cavities) treated with a steroid-eluting absorbable spacer and 128 patients (233 nasal cavities) treated with a nonabsorbable spacer. Eligible patients included those who underwent ESS (at minimum, maxillary antrostomy and anterior ethmoidectomy) for chronic rhinosinusitis with or without nasal polyps and were treated with a sinus spacer. Synechiae related outcomes were unavailable for 10 subjects in the absorbable spacer group (6.8%) and nine subjects in the nonabsorbable spacer group (7.0%) due to lack of 1-month follow up. Rates of synechiae formation at 1-month postoperatively did not differ significantly between groups (5 [2.0%] nasal cavities in the absorbable stent group vs 13 [5.6%] nasal cavities in the nonabsorbable spacer group).

Section Summary: Steroid-Eluting Stents as an Adjunct to Endoscopic Sinus Surgery

The most direct evidence relating to use of steroid-eluting nasal stents as an adjunct to ESS comes from 4 RCTs comparing steroid-eluting stents with either a non-steroid-eluting stent or medical management. The need for post-operative intervention at 30 days was reduced by 14% to 24%, translating to a number needed to treat of 4.7 or more. Three trials used blinded assessors to evaluate post implantation sinus changes, an important strength, but the trials had potentials for bias. To most accurately evaluate the benefit from PROPEL devices it is important to ensure that the comparison group is not undertreated (i.e., receives some form of packing, intranasal steroids, and irrigation).

Steroid-Eluting Stents for Recurrent Polyposis

Clinical Context and Therapy Purpose

The purpose of steroid-eluting stents in patients who have recurrent polyposis is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: does the use of steroid-eluting stents improve the net health outcome in patients with recurrent polyposis?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest are patients with recurrent polyposis after ESS.

Interventions

The therapy being considered is steroid-eluting stent (e.g., SINUVA).

This stent is bioresorbable and softens over time, but needs to be removed by 90 days.

Comparators

A sham treatment may be used to determine whether active treatment reduces the need for ESS.

Outcomes

The general outcomes of interest are symptoms, anatomic outcomes, and need for additional ESS. These outcomes may be measured by the nasal obstruction/congestion score change (scale 0–3), polyp grade change (scale 0 to 8), ethmoid sinus obstruction change (scale 0–100), and the percentage of patients still indicated for repeat sinus surgery.

A beneficial outcome would be an improvement in symptoms and reduction in repeat ESS.

A harmful outcome would be adverse events from the implantable stents.

Timing

The steroid-eluting stents are kept in place for up to 90 days. Relevant outcomes would be measured at 90 days to evaluate the short-term effects of the treatment and at one or two years to evaluate the durability of this treatment.

Setting

The setting is outpatient care by an otolaryngologist.

Review of Evidence

Two sham-controlled RCTs (RESOLVE and RESOLVE II) with a total of 400 patients have addressed outcomes after placement of steroid-eluting absorbable sinus stents in the office setting due to recurrent or persistent nasal polyposis after ESS (see Tables 5 and 6).

In RESOLVE, For endoscopically measured outcomes, at 90 days of follow-up, the treatment group had a greater reduction in polyp grade than the control group (-1.0 vs -0.1; p=0.016) and a greater reduction in percent ethmoid obstruction on a 100-mm VAS (-21.5 mm vs 1.3 mm; p=0.001), both respectively. For patient-reported outcomes, there were no significant differences in change in nasal obstruction/congestion scores between groups. In RESOLVE II the implant group showed significant reductions in nasal congestion, polyp grade, and ethmoid obstruction at 90 days compared to sham controls. Out of 200 patients treated with the implant, 39% were indicated for sinus surgery at 3 months compared to 63.3% of controls (p<0.001)

Table 5. Summary of Key RCT Characteristics

Study; Trial

Countries

Sites

Dates

Participants

Interventions

Active

Comparator

Han et al (2014); RESOLVE

100 patients with recurrent nasal polyposis after ESS who had chronic rhinosinusitis, had undergone prior bilateral total ethmoidectomy more than 3 months earlier, had endoscopically confirmed recurrent bilateral ethmoid sinus obstruction due to polyposis that was refractory to medical therapy, and were considered candidates for repeat surgery based on the judgment of the surgeon and patient.

53 patients who received office-based placement of a mometasone-eluting nasal stent

47 patients who received sham treatment

Kern et al (2018),; RESOLVE II

US

34

2014-2016

bilateral ethmoid sinus obstruction due to polyposis.
of nasal obstruction/congestion ; and (4) have endoscopic evidence of
1 year; (3) continue to have moderate-to-severe symptoms
refused such therapy due to side effects within the past
patient had to: (1) be using intranasal corticosteroid daily ; (2) receive at least 1 course of high-dose steroid therapy or
300 adults with refractory chronic rhinosinusitis with nasal polyps who were candidates for repeat surgery. To be indicated for repeat ESS, a

201 patients who received a SINUVA(TM) mometasone-eluting bioabsorbable nasal stent

99 patients who received sham treatment consisting of insertion and removal of implants

ESS: endoscopic sinus surgery; RCT: randomized controlled trial.

Table 6. Summary of Key RCT Results

Study

Nasal obstruction/congestion score change (scale 0–3)

Change in Polyp Grade at 90 Days (scale 0 to 8)

Reduction in Ethmoid Obstruction (scale 100) at 90 Days

Patients Indicated for Sinus Surgery at 3 months n (%)

Han et al (2014); RESOLVE

Drug-eluting nasal stent

-1.0

-21.5 mm

47%

Sham

-0.1

1.3 mm

77%

P-value

0.016

0.001

NR

Kern et al (2018); RESOLVE II

Drug-eluting nasal stent mean (SD)

−0.80 (0.73)

−0.56 (1.06)

−11.3 (18.1)

78/200 (39.0%)

Sham mean (SD)

−0.56 (0.62)

−0.15 (0.91)

−1.9 (14.4)

62/98 (63.3%)

Diff or OR (95% CI)

−0.23 (−0.39 to −0.06)

−0.35 (−0.60 to −0.09)

−7.96 (−12.10 to −3.83)

2.69 (1.63 to 4.44)

P-value

0.007

0.007

<0.001

<0.001

CI: confidence interval; NR: not reported; OR: odds ratio; RCT: randomized controlled trial.

Gaps in relevance and design and conduct are shown in Tables 7 and 8. A major limitation of the trials was the short duration of follow-up to determine the durability of the treatment. In addition, there is a potential for bias since outcomes were evaluated by the treating physician.

Table 7. Relevance Gaps

Study

aPopulation

bIntervention

cComparator

dOutcomes

eFollow-Up

Han et al (2014); RESOLVE

1. The 90 day follow-up is insufficient to evaluate the durability of this treatment.

Kern et al (2018); RESOLVE II

1. The 90 day follow-up is insufficient to evaluate the durability of this treatment.

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. the intervention of interest.c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 8. Study Design and Conduct Gaps

Study

aAllocation

bBlinding

cSelective Reporting

dData Completeness

ePower

fStatistical

Han et al (2014); RESOLVE

3. Outcomes were assessed by the treating physician

3. Statistics were not reported for some outcome measures.

Kern et al (2018); RESOLVE II

3. Polyp grade and sinus obstruction were assessed by the treating physician

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Steroid-Eluting Stents for Recurrent Polyposis

One RCT was identified evaluating the use of steroid-eluting nasal stents for recurrent/persistent nasal polyposis after ESS, which demonstrated improvements in polyp grade and ethmoid obstruction. Strengths of this trial include the use of a sham control and adequate power for its primary outcome. However, the trial is at high risk of bias due to unblinded outcome assessment. Although avoidance of repeat ESS and oral steroids may be a relevant outcome for this indication, it would be important for decisions about repeat ESS or other treatments to be standardized and prespecified or be made by a clinician blinded to treatment group. Sinus stents may prove to have a role in nasal polyposis; however, additional positive results from well-designed RCTs are needed to confirm the results of the single available RCT.

Summary of Evidence

For individuals who have chronic rhinosinusitis who have undergone ESS who receive implantable steroid-eluting sinus stents, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. The most direct evidence relating to use of steroid-eluting nasal stents as an adjunct to ESS comes from 4 RCTs comparing steroid-eluting stents with either a non-steroid-eluting stent or medical management. The need for post-operative intervention at 30 days was reduced by 14% to 24%, translating to a number needed to treat of 4.7 or more. Three trials used blinded assessors to evaluate post implantation sinus changes, an important strength, but the trials had potentials for bias. To most accurately evaluate the benefit from PROPEL devices it is important to ensure that the comparison group is not undertreated (i.e., receives some form of packing, intranasal steroids, and irrigation). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have recurrent sinonasal polyposis who have undergone endoscopic sinus surgery who receive implantable steroid-eluting sinus stents, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity. Two RCTs were identified evaluating the use of steroid-eluting nasal stents for recurrent or persistent nasal polyposis after ESS, which demonstrated improvements in polyp grade and ethmoid obstruction. Strengths of these trials included use of a sham control and adequate power for its primary outcome. However, the trials had a high risk of bias due to unblinded outcome assessment. Although avoidance of repeat ESS and oral steroids may be relevant outcomes for this indication, it would be more important if decisions about repeat ESS or other treatments were standardized and, in the trial setting, if decisions were prespecified or made by a clinician blinded to treatment group. Sinus stents may prove to have a role in nasal polyposis; however, further follow-up is needed to evaluate the durability of the results.. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Key Words:

Implantable sinus stents, implantable sinus spacers, PROPEL™, Relieva Stratus™ MicroFlow spacer, Mometasone furoate sinus implant, Sinuva (mometasone furoate), Sinu-Foam spacer

Approved by Governing Bodies:

Intraoperative Steroid-Eluting Sinus Stents

In 2011, the PROPEL(R) system (Intersect ENT, Menlo Park, CA) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (P100044). This device is a self-expanding, bioabsorbable, steroid-eluting stent intended for use in the ethmoid sinus. It is placed via endoscopic guidance using a plunger included with the device. Steroids (mometasone furoate) are released over an approximate duration of 30 days. The device dissolves over several weeks, and therefore does not require removal. In 2012, a smaller version of the PROPEL(R) device, the PROPEL(R) mini Sinus Implant, was approved for use in patients older than age 18 years following ethmoid sinus surgery. In 2017, the PROPEL Contour was approved through a PMA supplement. The PROPEL(R) Contour Sinus Implant is an adaptable implant that is designed to maximize drug delivery to the frontal and maxillary sinus.

Postoperative Steroid-Eluting Sinus Stents

SINUVA(TM) Sinus Implant (Intersect ENT, Inc., Menlo Park, CA) was initially approved in 1987. In 2017, the SINUVA(TM) Sinus Implant was approved with a new dose (1350 μg mometasone furoate) under a New Drug Application (NDA 209310). The corticosteroid is released over 90 days and the bioabsorbable polymers soften over this time. The implant is removed at Day 90 or earlier using standard surgical instruments. The SINUVA™ Sinus Implant is indicated for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery.

Sinu-Foam™ is a Food and Drug Administration (FDA)-approved mixture, which is commonly mixed with saline and gently placed in the ethmoid cavity following FESS. A dexamethasone Sinu-Foam spacer has been studied to examine if it could promote wound healing of the nasal and sinus mucosa by reducing the inflammation associated with CRS. However, its clinical utility remains a debate since it does not improve endoscopic outcomes in the early post-operative period following FESS.

Benefit Application:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

Current Coding:

CPT Codes:

30999                     Unlisted procedure, Nose

  31237                      Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure)

  31299                      Unlisted procedure, accessory sinuses

HCPCS Codes:

J3490                     Unclassified Drugs

  J7401                      Mometasone furoate sinus implant, 10 microgram (Effective 10/1/19)

Previous Coding:

  0406T                    Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; (Deleted 12/31/18)

                                   0407T                    ; with biopsy, polypectomy or debridement (Deleted 12/31/18)

             S1090                    Mometasone furoate sinus implant, 370 micrograms (Deleted 9/30/19)

References:

  1. Berlucchi M, Castelnuovo P, Vincenzi A et al. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study. Eur Arch Otorhinolaryngol 2009; 266(6):839-45.
  2. Catalona PJ TM, Weiss R, Rimash T. The MicroFlow Spacer: a drug-eluting stent for the ethmoid sinus. Indian J Otolaryngol Head Neck Surg 2011; 63(3):258.
  3. Cote DW, Wright ED. Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. Laryngoscope 2010; 120(6):1269-73.
  4. Forwith KD, Chandra RK, Yun PT et al. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope 2011; 121(11):2473-80.
  5. Forwith KD, Han JK, Stolovitzky JP, et al. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016; 6: 573-581.
  6. Food & Drug Administration, Office of Criminal Investigations. July 22, 2016: Medical Device Manufacturer Acclarent Inc. to Pay $18 Million to Settle False Claims Act Allegations. 2016; https://www.fda.gov/iceci/criminalinvestigations/ucm512838.htm. Accessed January 18, 2018.
  7. Freeman SR, Sivayoham ES, Jepson K et al. A preliminary randomised controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery. Clin Otolaryngol 2008; 33(5):462-5.
  8. Han J, Forwith K, Brown W, et al. A Randomized, Controlled, Blinded, Multi-Center Study with Bioabsorbable Steroid-Eluting Sinus Implant for In-Office Treatment of Recurrent Sinonasal Polyposis: 3-Month Safety and Efficacy American Rhinologic Society (ARS at AAO) -- 60th Annual Meeting; September 20, 2014. 2014; Orlando, Florida.
  9. Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. Nov 2014; 4(11):861-870.
  10. Han JK, Marple BF, Smith TL. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol 2012; 2(4):271-9.
  11. https://www.sinuva.com/. Accessed February 09, 2018.
  12. Huang Z, Hwang P, Sun Y, et al. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015; 6:CD010436.
  13. https://www.sinuva.com
  14. www.spiroxmed.com/latera/
  15. Kern, RR, Stolovitzky, JJ, Silvers, SS, Singh, AA, Lee, JJ, Yen, DD, Iloreta, AA, Langford, FF, Karanfilov, BB, Matheny, KK, Stambaugh, JJ, Gawlicka, AA. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol, 2018 Jan 20;8(4).
  16. Lavigne F, Miller SK, Gould AR, et al. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. May 2014; 4(5):381-389.
  17. Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol 2012; 2(6): 477-486.
  18. Luong, AA, Ow, RR, Singh, AA, Weiss, RR, Han, JJ, Gerencer, RR, Stolovitzky, JJ, Stambaugh, JJ, Raman, AA. Safety and Effectiveness of a Bioabsorbable Steroid-Releasing Implant for the Paranasal Sinus Ostia: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg, 2017 Nov 4.
  19. Marple BF, Smith TL, Han JK et al. Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngol. Head Neck Surg. 2012; 146(6):1004-11.
  20. Matheny KE, Carter KB, Jr., Tseng EY, et al. Safety, feasibility, and efficacy of placement of steroid-eluting bioabsorbable sinus implants in the office setting: a prospective case series. Int Forum Allergy Rhinol. Sep 15 2014.
  21. Murr AH, Smith TL, Hwang PH et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol 2011; 1(1):23-32.
  22. Ow R, Groppo E, Clutter D, et al.
  23. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. Int Forum Allergy Rhinol. Sep 25 2014.
  24. Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-Foam™ middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. 2012; 2(3):248-251.
  25. Rotenberg BW, Zhang I, Arra I et al. Postoperative care for Samter's triad patients undergoing endoscopic sinus surgery: a double-blinded, randomized controlled trial. Laryngoscope 2011; 121(12):2702-5.
  26. Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-FoamTM middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. Jan 17 2012;2(3):248-251.
  27. Rudmik L MJ, Mechor B. Effect of a dexamethasone SinuFoam middle meatal spacer on endoscopic sinus surgery outcomes: A randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. 2012 May-Jun; 2(3):248-51.
  28. Rudmik L, Soler ZM, Orlandi RR et al. Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations. Int Forum Allergy Rhinol 2011; 1(6):417-30.
  29. Sedaghat AR. Chronic rhinosinusitis. Am Fam Physician. Oct 15 2017; 96(8):500-506.
  30. Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stamaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016; 126:2659-2664.
  31. Xu JJ, Busato GM, McKnight C, et al. Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. Ann Otol Rhinol Laryngol. Sep 21 2015.
  32. Xu JJ, Busato GM, McKnight C, et al. Absorbable steroid-impregnated spacer after endoscopic sinus surgery to reduce synechiae formation. Ann Otol Rhinol Laryngol. Mar 2016;125(3):195-198.

Policy History:

Medical Policy Panel, July 2012

Medical Policy Group, July 2012 (2) New policy

Medical Policy Administration Committee, July 2012

Available for comment July 26 through September 4, 2012

Medical Policy Panel, November 2013

Medical Policy Group, January 2014 (2): No change to policy statement.  “Spacer” removed from title and body of policy. Key Points, Approved by Governing Bodies, Key Words, References updated with results of literature search through September 2013. 

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (5): Updates to Description, Key Points and References. No Policy change.

Medical Policy Group, November 2015: 2016 Annual Coding Update. Added CPT codes 0406T and0407T to Current Coding; also added a Previous Coding section.

Medical Policy Panel, February 2016

Medical Policy Group, February 2016 (2): 2016 Updates to Title, Description, Key Points, and References; policy statement updated to include “and for treatment of recurrent sinonasal polyposis- no change in coverage- policy remains investigational.

Medical Policy Panel, February 2017

Medical Policy Group, March 2017 (6): Updates to Key Points. No change to policy statement.

Medical Policy Group, February 2018 (6): Updated Governing Bodies, Key Words and References to include Sinuva. No change to policy intent.

Medical Policy Group, February 2018 (6): Clarified policy title and statement to include “drug- eluting implants”. Updated policy with Sinu-Foam™ to Key Points, Coding and Governing Bodies. No change to policy intent.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (6): Updates to Description, Key Points and References.

Medical Policy Group, May 2018 (6): Updates to Description, Governing Bodies, Coding and References to include Sinuva and LATERA; added “nasal” to policy statement, Latera already investigational per DORS.

Medical Policy Group, October 2018 (6): Information for Latera moved to MP #721 Absorbable Nasal Implant for Treatment of Nasal Valve Collapse.

Medical Policy Group, December 2018: 2019 Annual Coding Update. Moved CPT codes from Current coding section to Previous coding. Updated Previous coding section to include codes 0406T and 0407T.

Medical Policy Panel February 2019

Medical Policy Group, March 2019 (6): Updates to Description, Key Points, Governing Bodies, Coding (added 31237/ 31299) and References.

Medical Policy Group, September 2019: October 2019 quarterly coding update.  Added new CPT code J7401 to Current Coding.  Moved deleted code S1090 to Previous Coding section.


This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.