Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery

Figures & data

Table 1. Demographic characteristics by cohorts.

	Implant		Non-implant
	N = 1983		N = 1983
	N/Mean	%/SD	N/Mean	%/SD
Age (Mean, SD)	46.9	14.2	47.3	15.2
Sex (N, %)
Female	1069	53.9%	1017	51.3%
Male	914	46.1%	966	48.7%
Race (N, %)^a
N reported patients	585		551
Caucasian	493	84.3%	472	85.7%
African American	79	13.5%	59	10.7%
Asian	11	1.9%	13	2.4%
Other	2	0.3%	7	1.3%
Insurance type (N, %)^a
N reported patients	1482		1572
Commercial	1318	88.9%	1280	81.4%
Medicaid or Medicare	47	3.1%	131	8.3%
Other	117	7.9%	161	10.2%

Abbreviations: SD, standard deviation.

^aPercentages were calculated using the N reported patients as the denominator.

Table 2. Characterization of the index sinus surgery by cohort.

	Implant	Non-implant
	N = 1983	N = 1983
	N (%)	N (%)
Number of sinuses treated
Multiple	1879 (94.8%)	1687 (85.1%)
One	104 (5.2%)	296 (14.9%)
Type of sinuses treated^a
Maxillary	1800 (90.8%)	1768 (89.2%)
Ethmoid	1513 (76.3%)	1187 (59.9%)
Frontal	1468 (74.0%)	1051 (53.0%)
Sphenoid	1048 (52.8%)	763 (38.5%)
Unknown	11 (0.6%)	87 (4.4%)
Facility type
Outpatient^b	1967 (99.2%)	1960 (98.8%)
Inpatient	16 (0.8%)	21 (1.1%)
Unknown	0 (0.0%)	2 (0.1%)
Year of index surgery
2014	74 (3.7%)	73 (3.7%)
2015	349 (17.6%)	402 (20.3%)
2016	585 (29.5%)	544 (27.4%)
2017	451 (22.7%)	448 (22.6%)
2018	415 (20.9%)	410 (20.7%)
2019	109 (5.5%)	106 (5.3%)
Number of prior sinus surgeries
0	1694 (85.4%)	1694 (85.4%)
1	248 (12.5%)	248 (12.5%)
2 or more	41 (2.1%)	41 (2.1%)

^aThe OM1 Real-World Data Cloud provides data on the type of sinuses treated, but not on the specific sinus location of implant placement or the type of implant used. None of the studied implants are approved for placement in sphenoid.

^bOutpatient facility included day surgery and ambulatory services.

Table 3. Baseline characteristics by cohort.

	Implant		Non-implant
	N = 1983		N = 1983
	Mean/N	SD/%	Mean/N	SD/%
CRS (N, %)
CRSsNP	995	50.2%	995	50.2%
CRSwNP	988	49.8%	988	49.8%
Deyo-Charlson comorbidity index (Mean, SD)^a	0.9	1.3	0.8	1.2
Comorbid condition of interest (N, %)
Allergic rhinitis	1239	62.5%	1232	62.1%
Asthma	662	33.4%	710	35.8%
Sleep disorders^b	514	25.9%	558	28.1%
COPD	325	16.4%	322	16.2%
Eustachian tube dysfunction	253	12.8%	256	12.9%
Immunodeficiency disorders	57	2.9%	46	2.3%
Sensitivity/allergy to aspirin or NSAIDs	50	2.5%	50	2.5%
Allergic fungal rhinosinusitis	4	0.2%	3	0.2%

Abbreviations: COPD, chronic obstructive pulmonary disease; CRS, chronic rhinosinusitis; CRSsNP, CRS without nasal polyps; CRSwNP, CRS with nasal polyps; NSAIDs, nonsteroidal anti-inflammatory drugs; SD, standard deviation.

^aThe Deyo-Charlson comorbidity index or CCI is a weighted score that is calculated based on the presence of a range of comorbidities recorded in administrative data. The CCI is used to measure burden of disease, with higher scores indicating a more severe level of comorbidity, and consequently a worse prognosis. [20].

^bIncludes sleep apnea, nighttime awakening due to congestion, and snoring.

Table 4. Characterization of repeat sinus surgery during 18 months following the index surgery in the matched cohorts.

	0 to 6 months		>6 to 12 months		>12 to 18 months		Overall (0 to 18 months)
	Implant	Non-implant	Implant	Non-implant	Implant	Non-implant	Implant	Non-implant
	N = 1983	N = 1983	N = 1983	N = 1983	N = 1983	N = 1983	N = 1983	N = 1983
	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)
Repeat surgery	40 (2.0%)	40 (2.0%)	30 (1.5%)	40 (2.0%)	28 (1.4%)	35 (1.8%)	91 (4.6%)	106 (5.3%)
Characteristics (% among patients with repeat surgery)
Implant^a	15 (37.5%)	0	8 (26.7%)	0	5 (17.9%)	0	28 (30.8%)	0
Type of sinus
Maxillary	23 (57.5%)	31 (77.5%)	25 (83.3%)	33 (82.5%)	17 (60.7%)	30 (85.7%)	62 (68.1%)	88 (83.0%)
Sphenoid	12 (30.0%)	6 (15.0%)	18 (60.0%)	15 (37.5%)	14 (50.0%)	10 (28.6%)	40 (44.0%)	31 (29.2%)
Frontal	2 (5.0%)	1 (2.5%)	0	1 (2.5%)	0	0	2 (2.2%)	2 (1.9%)
Ethmoid	1 (2.5%)	0	0	0	0	0	1 (1.1%)	0
Characteristics (% among the total number of patients)
Implant^a	15 (0.8%)	0	8 (0.4%)	0	5 (0.3%)	0	28 (1.4%)	0
Type of sinus
Maxillary	23 (1.2%)	31 (1.6%)	25 (1.3%)	33 (1.7%)	17 (0.9%)	30 (1.5%)	62 (3.1%)	88 (4.4%)
Sphenoid	12 (0.6%)	6 (0.3%)	18 (0.9%)	15 (0.8%)	14 (0.7%)	10 (0.5%)	40 (2.0%)	31 (1.6%)
Frontal	2 (0.1%)	1 (0.1%)	0	1 (0.1%)	0	0	2 (0.1%)	2 (0.1%)
Ethmoid	1 (0.1%)	0	0	0	0	0	1 (0.1%)	0

^aRepresents patients who underwent a repeat sinus surgery with steroid-eluting sinus implants. Data on specific sinus location of implant placement and the type of implant used were not available in the OM1 Real-World Data Cloud. None of the studied implants are approved for placement in sphenoid.

Table 5. Healthcare visits and procedures during 18 months following the index sinus surgery in the matched cohorts^a.

	Overall (0 to 18 months)
	Implant	Non-implant	p-value
	N = 198)	N = 1983
	N (%)	N (%)
Healthcare visits (N, %)
All-cause outpatient	1869 (94.3%)	1915 (96.6%)	<.001
All-cause otolaryngologist	938 (47.3%)	1182 (59.6%)	<.001
All-cause ER/urgent care	182 (9.2%)	234 (11.8%)	.007
Sinus procedures performed (N, %)
Endoscopy	775 (39.1%)	868 (43.8%)	.003
Debridement	384 (19.4%)	361 (18.2%)	.350
Polypectomy	4 (0.2%)	1 (0.1%)	.179
Sinus-related imaging (N, %)
CT	201 (10.1%)	172 (8.7%)	.115
MRI	32 (1.6%)	19 (1.0%)	.067
X-ray	16 (0.8%)	18 (0.9%)	.730

Abbreviations: CT, computed tomography scans; ER, emergency room; MRI, magnetic resonance imaging.

^aValues represent counts and percentages of patients with at least one visit (or procedure) during the specified time frame. Patients with multiple types of visits (or procedures) are counted under each type.

Table 6. Healthcare visits and procedures during each 6-month interval following the index sinus surgery in the matched cohorts^a.

	0 to 6 months			>6 to 12 months			>12 to 18 months
	Implant	Non-Implant	p-value	Implant	Non-Implant	p-value	Implant	Non-Implant	p-value
	N = 1983	N = 1983		N = 1983	N = 1983		N = 1983	N = 1983
	N (%)	N (%)		N (%)	N (%)		N (%)	N (%)
Healthcare visits (N, %)
All-cause outpatient	1712 (86.3%)	1820 (91.8%)	<0.001	1507 (76.0%)	1549 (78.1%)	0.113	1430 (72.1%)	1449 (73.1%)	.499
All-cause otolaryngologist	885 (44.6%)	1117 (56.3%)	<0.001	378 (19.1%)	486 (24.5%)	<0.001	273 (13.8%)	383 (19.3%)	<.001
All-cause ER/urgent care	68 (3.4%)	100 (5.0%)	0.012	83 (4.2%)	109 (5.5%)	0.054	90 (4.5%)	108 (5.4%)	.189
Procedures performed
Endoscopy	643 (32.4%)	734 (37.1%)	0.002	329 (16.6%)	356 (18.0%)	0.257	234 (11.8%)	259 (13.1%)	.229
Sinus debridement	348 (17.5%)	321 (16.2%)	0.252	60 (3.0%)	53 (2.7%)	0.504	36 (1.8%)	33 (1.7%)	.716
Polypectomy	3 (0.2%)	0	0.083	0	0	−	1 (0.1%)	1 (0.1%)	1.000
Sinus-related imaging (N, %)
CT	95 (4.8%)	71 (3.6%)	0.057	74 (3.7%)	74 (3.7%)	1.000	60 (3.0%)	48 (2.4%)	.242
MRI	16 (0.8%)	11 (0.6%)	0.334	8 (0.4%)	4 (0.2%)	0.247	9 (0.5%)	5 (0.3%)	.284
X-rays	5 (0.3%)	9 (0.5%)	0.284	6 (0.3%)	6 (0.3%)	1.000	6 (0.3%)	5 (0.3%)	.763

Abbreviations: CT, computed tomography scans; ER, emergency room; MRI, magnetic resonance imaging.

^aValues represent counts and percentages of patients with at least one visit (or procedure) during the specified time frame. Patients with multiple types of visits (or procedures) are counted under each type.

Javanbakht M, Saleh H, Hemami MR, et al. A corticosteroid-eluting sinus implant following endoscopic sinus surgery for chronic rhinosinusitis: a UK-based cost-effectiveness analysis. Pharmacoecon Open. 2020;4(4):679–686.

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