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

Forwith, Keith D.; Han, Joseph K.; Stolovitzky, J. Pablo; Yen, David M.; Chandra, Rakesh K.; Karanfilov, Boris; Matheny, Keith E.; Stambaugh, James W.; Gawlicka, Anna K.

doi:10.1002/alr.21741

Cited by 52 publications

(63 citation statements)

References 21 publications

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“…Implanted SESs included the Intersect ENT Propel Mini or Contour, an unnamed Intersect ENT‒provided steroid‐eluting stent, SinuBand fluticasone propionate, and the Relieva Stratus MicroFlow Spacer . The sites of local implantation and delivery were ethmoid sinus cavity and frontal sinus ostia . A summary of the analyzed studies with their respective primary and secondary outcome variables are presented in Table .…”

Section: Resultsmentioning

confidence: 99%

“…All included studies in the quantitative analyses were industry‐sponsored RCTs. All 7 studies utilized intrapatient controls (using different sinuses in the same patient), except Forwith et al (sham surgery). These 7 studies prescribed a 10‐ or 14‐day course of antibiotics postoperatively for all subjects, with the exception of Forwith et al, who prescribed daily doses of steroid nasal spray.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of steroid‐eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta‐analysis

Goshtasbi

Abouzari

Abiri

et al. 2019

Int Forum Allergy Rhinol

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Background:Recently, there has been mounting evidence suggesting the efficacy of steroid-eluting stents (SES) for management of chronic rhinosinusitis a er endoscopic sinus surgery (ESS). This meta-analysis serves to evaluate the efficacy of SES in improving postoperative outcomes a er ESS. Methods:A systematic literature search was performed of PubMed for articles published between 1985 and 2018. The outcome variables were reported at, on average, 30 days postintervention.Results: Seven of the 76 published studies, all of which were industry-sponsored, were included for a collective cohort of 444 SES and 444 control sinuses. In patients who received SES vs controls, collective odds ratios (ORs) for postoperative need for intervention, surgery, and oral steroid were 0.45 (95% confidence interval [CI], 0.33-0.62; p < 0.001), 0.30 (95% CI, 0.18-0.52; p < 0.001), and 0.58 (95% CI, 0.40-0.84; p = 0.004), respectively. In addition, collective ORs for frontal sinus ostia (FSO) patency, moderate-to-severe adhesion/scarring, and increase in polyp score were 2.53 (95% CI, 1.61-3.97; p < 0.001), 0.28 (95% CI, 0.13-0.59; p < 0.001), and 0.42 (95% CI, 0.25-0.74; p = 0.002), respectively. Collective mean differences for FSO/ethmoid inflammation and FSO diameter were −10.86 mm (p < 0.001) and +1.34 mm (p < 0.001), respectively. Conclusion:Aggregate evidence suggests that SES can improve ESS outcomes by reducing rates of postoperative intervention and recurrent polyposis and inflammation, while promoting FSO patency. All included and analyzed studies were industry-sponsored and ruling-out publication bias was not possible. Future independent and nonsponsored studies to further evaluate SES's long-term efficacy are warranted. C 2019 ARS-AAOA, LLC.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Efficacy of steroid‐eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta‐analysis

Goshtasbi

Abouzari

Abiri

et al. 2019

Int Forum Allergy Rhinol

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“…However, few studies have focused on patient-reported QOL outcomes with the use of this device, and the relative efficacy in the treatment of different phenotypes of CRS has not been analyzed in previous studies [6][7][8]12]. The goal of this study was to determine if a bioabsorbable steroid-eluting implant would have a differential effect on patient-reported QOL relative to the status of baseline eosinophilia.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies examining the utility of adjuvant use of a bioabsorbable steroid-eluting implant in ESS have demonstrated its safety and clinical effectiveness in CRS patients in general [6][7][8]12]. However, it is unclear which patient groups are most likely to benefit from this technology.…”

Section: Introductionmentioning

confidence: 99%

Eosinophilia and Quality of Life in Patients Receiving a Bioabsorbable Steroid-Eluting Implant during Endoscopic Sinus Surgery

Pou

Riley

Tipirneni³

et al. 2017

Sinusitis

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Abstract:Introduction: Bioabsorbable steroid-eluting implants are available as an adjunct for endoscopic sinus surgery (ESS) in the treatment of chronic rhinosinusitis (CRS). It is unclear which patients are most likely to benefit from this technology. We sought to determine if the severity of preoperative sinonasal inflammation influences the postoperative changes in patient-reported quality of life (QOL) and endoscopic appearance following ESS with implant placement; Methods: Consecutive adult patients undergoing ESS for CRS with ethmoidectomy and placement of a steroid-eluting implant over an 18-month period were prospectively included for study. Pre-operative sinus computed tomography (CT) opacification was evaluated using the Lund-Mackay score (LMS). Sinonasal Outcome Test (SNOT-22) scores and Lund-Kennedy endoscopic scores (LKES) for each patient were collected preoperatively and at three-and six-month intervals postoperatively. Serum eosinophilia (>6.0% on peripheral smear) and sinus tissue eosinophilia were recorded; Results: One hundred and thirty-six patients were included for analysis. Of these, 36.7% had polyposis, 15.4% had serum eosinophilia and 64.0% had tissue eosinophilia. The mean (standard deviation) SNOT-22 score was 45.5 (19.4) preoperatively, which improved postoperatively to 18.8 (14.1) at three months (p < 0.001) and 16.5 (14.0) at six months (p < 0.001). Similar results were found when stratified by the presence of polyposis, serum eosinophilia, tissue eosinophilia or high-grade CT findings (LMS > 6). Higher baseline LKES was observed for patients with eosinophilia or high-grade LMS, but these differences normalized at six months postoperatively; Conclusions: Patient-reported QOL and endoscopic appearance show improvement six months after placement of a steroid-eluting implant during ESS, irrespective of the presence of polyposis or eosinophilia.

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“…At 6 months, the treated patients had statistically significant improvement in Nasal Obstruction Symptom Evaluation score (p = 0.021) and greater than 2-fold improvement in mean nasal obstruction score (p = 0.124). 17 The treatment Han et al 16 RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid -eluting sinus implants for in office treatment of recurrent sinonasal polyposis.…”

Section: Sinuva Clinical Studiesmentioning

confidence: 99%

Topical therapies for management of chronic rhinosinusitis: steroid implants

Han

Kern

2019

Int Forum Allergy Rhinol

Self Cite

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Background: Chronic rhinosinusitis (CRS) causes severe symptoms that lead to poor quality of life. When optimal medical therapy does not improve CRS symptoms, then endoscopic sinus surgery (ESS) can be used in patients with persistent symptoms and radiographic evidence of CRS to improve patients' symptoms and quality of life. Despite appropriate and complete sinus surgery, there can be issues a er sinus surgery such as synechiae formation and recurrence of polyps in certain CRS patients that can decrease long-term outcomes. Corticosteroids are used to decrease postoperative scarring and edema as well as prevent recurrence of nasal polyp formation a er sinus surgery. However, the use of oral or systemic steroid can lead to serious shortterm and long-term complications. Therefore, a safer alternative would be the topical delivery of steroid via steroideluting sinus implants. Methods:A literature review was performed to identify clinical studies evaluating steroid-eluting implants. Two forms of steroid-eluting implants were identified, Propel family products and Sinuva. The research findings from clinical studies using various steroid-eluting sinus implants are reviewed and discussed. Results:Four prospective randomized clinical studies were identified for the Propel family products. Two prospective randomized clinical studies were identified for Sinuva. The results from the clinical studies showed that the use of the various steroid-eluting sinus implants can improve postoperative results a er ESS as well as treat the recurrence of nasal polyps a er sinus surgery without the need for additional sinus surgery. Conclusion:The novel steroid-eluting implants appear to be beneficial for CRS patients immediately postoperatively as well as for nasal polyps patients. Interestingly, these implants could be used as a substitute for the beneficial effect of systemic steroid use for CRS patients. C 2019 ARS-AAOA, LLC.

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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

Cited by 52 publications

References 21 publications

Efficacy of steroid‐eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta‐analysis

Efficacy of steroid‐eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta‐analysis

Eosinophilia and Quality of Life in Patients Receiving a Bioabsorbable Steroid-Eluting Implant during Endoscopic Sinus Surgery

Topical therapies for management of chronic rhinosinusitis: steroid implants

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