Observational evaluation of outcomes and resource utilization from hemostatic matrices in spine surgery

Figures & data

Figure 1. Scanning electron microscopic images of (A) bovine-derived gelatin (Floseal) and (B) porcine-derived gelatin (Surgiflo). (Baxter data on file.)

Figure 2. Patient selection criteria.

Table 1. Listing of primary or secondary ICD-9 procedural codes for group assignment.

Major spine surgery group

81.62: Fusion/refusion vertebrae 2–3

03.4: Tumor resection

80.89: Tumor resection

Severe spine surgery group

81.63: Fusion/refusion vertebrae 4–8

81.64: Fusion/refusion vertebrae 9+

03.4 or 80.89 Tumor resection + 80.99: Corpectomy or 81.62–81.64 Fusion/refusion vertebrae 2–3, 4–8, 9+

03.53: Fracture stabilization + 81.62–81.64 Fusion/refusion vertebrae 2–3, 4–8, 9+

03.53: Fracture stabilization + 80.99: Corpectomy or 80.89: Osteotomy + 81.62–81.64 Fusion/refusion vertebrae 2–3, 4–8, 9+

Table 2. Selection patient and provider characteristics.^a

Patient characteristics	Group A		p Value^b	Group B		p Value^b
	FLOSEAL n (%)	SURGIFLO n (%)		FLOSEAL n (%)	SURGIFLO n (%)
Number of cases	12,783 (89%)	1531 (11%)		2837 (94%)	174 (6%)
Age: Mean (SD)	55.7 (13.4)	55.7 (12.6)	0.99	59.7 (15.3)	59.1 (14.8)	0.61
Gender			0.43			0.57
Female	6935 (54%)	847 (55%)		1481 (52%)	87 (50%)
Male	5848 (46%)	684 (45%)		1356 (48%)	87 (50%)
Race^c			<0.0001			0.05
White	9748 (76%)	827 (54%)		2219 (75%)	116 (67%)
Black	754 (6%)	70 (5%)		213 (8%)	17 (10%)
Other	2281 (18%)	634 (41%)		495 (17%)	41 (24%)
Patient on anti-platelet/coagulants			0.69			0.08
Yes	2365 (18%)	241 (16%)		995 (35%)	48 (28%)
No	10,418 (82%)	1290 (84%)		1842 (65%)	126 (72%)
CCI Score			<0.001			0.93
0	8205 (64%)	949 (62%)		1526 (54%)	91 (52%)
1	3081 (24%)	348 (23%)		747 (26%)	47 (27%)
2+	1497 (12%)	234 (15%)		564 (20%)	36 (21%)
Admission type			<0.0001			0.004
Elective	10,903 (85%)	1456 (95%)		2153 (76%)	150 (86%)
Emergent	962 (8%)	48 (3%)		426 (15%)	11 (6%)
Urgent	918 (7%)	27 (2%)		258 (9%)	13 (7%)
Hospital characteristics
Number of hospitals/physicians	154/12,783	34/1531		114/2837	28/174
Teaching hospital			<0.001			<0.0001
Yes	5008 (39%)	1159 (76%)		902 (32%)	106 (61%)
No	7775 (61%)	372 (24%)		1935 (68%)	68 (39%)
US region			<0.0001			<0.0001
East	2566 (20%)	557 (36%)		434 (15%)	61 (35%)
Central	3679 (29%)	285 (19%)		917 (32%)	60 (34%)
West	6538 (51%)	689 (45%)		1486 (52%)	53 (30%)
Bed size			<0.0001			<0.0001
0–199	988 (8%)	132 (9%)		206 (7%)	16 (9%)
200–299	2076 (16%)	189 (12%)		521 (18%)	30 (17%)
300–499	5397 (42%)	122 (8%)		1240 (44%)	27 (16%)
500+	4322 (34%)	1088 (71%)		870 (31%)	101 (58%)

^aAll data are n (%) unless otherwise stated and % may not total 100 due to rounding.

^bp Value from Chi-square test for categorical variables and student’s T-test for continuous variables.

^cRace categories: white/non-Hispanic, black/Hispanic, other.

CCI, Charlson Comorbidity Index; n, number; SD, standard deviation.

Table 3. Results of Group A.

Comparative outcomes	FLOSEAL only (reference group) compared to SURGIFLO only
	FLOSEAL (n = 12,783)	SURGIFLO (n = 1531)	Odds ratio (95% CI)^a/ Adjusted difference^b	p Value^d
Complications, n (%)^e
Blood loss related complications	928 (7.3)	80 (5.2)	1.10 (0.86–1.43)	0.44
Severe complications	200 (1.6)	19 (1.2)	0.74 (0.44–1.25)	0.26
Other complications	464 (3.6)	50 (3.3)	0.99 (0.72–1.35)	0.94
Transfusion, n (%)^e
Any transfusions	365 (2.9)	47 (3.1)	2.56 (1.79–3.65)	<0.0001
Day 1 transfusions	143 (1.1)	14 (0.9)	1.58 (0.87–2.89)	0.13
Day 2–4 transfusions	250 (2.0)	37 (2.4)	3.3 (2.2–4.98)	<0.0001
Any PRBC transfusions	346 (2.7)	43 (2.8)	2.54 (1.75–3.67)	<0.0001
Hospital LOS (days), Mean (95% CI)^b	2.8 (2.7–2.8)	2.7 (2.5–2.8)	−0.11 days	0.06
Surgery time (min), Mean (95% CI)^b	190 (187–193)	199 (194–203)	8.84 min	<0.0001
Amount product used (mL), Mean (95% CI)^b	7.6 (7.5–7.8)	11 (10.6–11.4)	3.35 mL	<0.001

^aOdds ratios from logistic regression for all binary outcome variables.

^bRatios and adjusted mean value for each group from GLM Negative binomial regression analyses.

^cRelative risk converted from adjusted odds ratio and percentage of event in each group.

^dp Value from logistic regressions or GLM.

^en (%) from unadjusted frequency tables.

CI, confidence interval; LOS, length of stay; min, minutes; n, number of cases; PRBC, Packed Red Blood Cells.

Table 4. Results of Group B.

Comparative outcomes	FLOSEAL only (reference group) compared to SURGIFLO only
	FLOSEAL (n = 2837)	SURGIFLO (n = 174)	Odds ratio (95% CI)^a/ Adjusted difference^b	p Value^d
Complications, n (%)^e
Blood loss related complications	527 (18.6)	21 (12.1)	0.81 (0.50–1.32)	0.40
Severe complications	196 (6.9)	7 (4.0)	0.62 (0.28–1.40)	0.25
Other complications	196 (6.9)	12 (6.9)	0.98 (0.52–1.84)	0.94
Transfusion, n (%)^e
Any transfusions	331 (11.7)	17 (9.8)	1.42 (0.82–2.46)	0.21
Day 1 transfusions	189 (6.7)	5 (2.9)	0.66 (0.26–1.67)	0.38
Day 2–4 transfusions	218 (7.7)	11 (6.3)	1.60 (0.82–3.12)	0.17
Any PRBC transfusions	320 (11.3)	15 (8.6)	1.28 (0.72–2.28)	0.41
Hospital LOS (days), Mean (95% CI)^b	4.4 (4.2–4.6)	4.3 (3.9–4.8)	−0.12 day	0.57
Surgery time (min), Mean (95% CI)^b	266 (258–273)	293 (276–311)	26.94 min	<0.001
Amount product used (mL), Mean (95% CI)^b	10.2 (9.7–10.7)	11.7 (10.5–13)	1.52 mL	0.008

^aOdds ratios from logistic regression for all binary outcome variables.

^bRatios and adjusted mean value for each group from GLM Negative binomial regression analyses.

^cRelative risk converted from adjusted odds ratio and percentage of event in each group.

^dp Value from logistic regressions or GLM.

^en (%) from unadjusted frequency tables.

CI, confidence interval; LOS, length of stay; min, minutes; n, number of cases; PRBC, Packed Red Blood Cells.