Floseal only versus in combination in spine surgery: a comparative, retrospective hospital database evaluation of clinical and healthcare resource outcomes

Figures & data

Table 1. Percentages of patients with specific complication events, by surgical subgroup.

Complication	Cardiac	Vascular	Non-cardiac Thoracic	Solid organ	General	Reproductive organ	Knee/hip replacement	Spinal
Total number of patients	103,829	216,199	142,562	45,687	362,512	384,132	246,815	107,187
Bleeding event only (%)	0.90	1.90	0.70	1.00	0.50	0.80	0.50	0.50%
Re-operation to control bleeding only (%)	0.40	0.40	4.70	0.60	1.90	0.20	0.00	0.20%
Blood product transfusion only (%)	40.90	25.20	22.70	22.80	19.90	5.70	28.60	13.60%
Bleeding event and blood product transfusion (%)	2.50	2.40	1.20	1.80	0.70	0.50	0.70	0.60%
Bleeding event and re-operation to control bleeding (%)	0.30	0.10	0.40	0.10	0.10	0.10	0.00	0.00%
Re-operation to control bleeding and blood product transfusion (%)	1.00	1.10	3.30	1.50	4.10	0.10	0.00	0.10%
Bleeding event re-operation to control bleeding and blood product transfusion (%)	1.40	0.40	1.30	0.70	0.30	0.10	0.00	0.00%
Any bleeding-related consequences (%)	47.40	31.50	34.30	28.50	27.50	7.50	29.80	15.00%

Source: Own elaboration with data obtained from Stokes E, Ye X, Shah M, et al. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011;11:135. Doi: 10.1186/1472–6963-11-135. © 2011 Stokes et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Figure 1. Estimated net cost impact of using Floseal versus Surgiflo in an average US hospital performing 245 cardiac surgical procedures per year.

Source: Own elaboration with data obtained from Makhija D, Rock M, Xiong Y, et al. Cost-consequence analysis of different active flowable hemostatic matrices in cardiac surgical procedures, Journal of Medical Economics. 2017;20(6):565–573, DOI: 10.1080/13,696,998.2017.1284079 homepage: http://www.tandfonline.com/loi/ijme20.

Table 2. Group assignment by primary or secondary ICD-9 procedural codes.

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+
Minor spine surgery group	81.02, 81.03: initial cervical fusion 81.32, 81.33: repeat cervical fusion 81.04, 81.05, 81.06, 81.07, 81.08: initial lumbar fusion 81.34, 81.35, 81.36, 81.37, 81.38: repeat lumbar fusion 81.00: initial fusion 81.30: repeat fusion

Table 3. Patient and provider characteristics after propensity score matching.

	Floseal only (N = 15,105)	Floseal + gelatin/thrombin (N = 15,105)	p-Value
Age (years)			0.4453
Mean (SD)	57.4 (13.6)	57.5 (13.5)
Min, median, max	89, 18, 58	89, 18, 58
Gender, n (%)			0.6783
Male	7153 (47.4%)	7189 (47.6%)
Female	7952 (52.6%)	7916 (52.4%)
Race, n (%)			< 0.0001
White	11,651 (77.1%)	12,093 (80.1%)
Black	1242 (8.2%)	1188 (7.9%)
Other	2212 (14.6%)	1824 (12.1%)
CCI score, n (%)			0.3711
0	8567 (56.7%)	8684 (57.5%)
1	4398 (29.1%)	4300 (28.5%)
2+	2140 (14.2%)	2121 (14.0%)
Anticoagulant/antiplatelet use, n (%)			0.0003
Yes	2255 (14.9%)	2485 (16.5%)
No	12,850 (85.1%)	12,620 (83.5%)
Admission type, n (%)			0.0214
Emergency	1527 (10.1%)	1405 (9.3%)
Urgent	1394 (9.2%)	1335 (8.8%)
Elective	12,184 (80.7%)	12,365 (81.9%)
Surgery type, n (%)			0.1938
Primary	14,427 (95.5%)	14,473 (95.8%)
Secondary	678 (4.5%)	632 (4.2%)
Surgery severity, n (%)			0.2339
Severe	166 (1.1%)	173 (1.1%)
Major	755 (5.0%)	693 (4.6%)
Minor	14,184 (93.9%)	14,239 (94.3%)
Teaching facility, n (%)			0.0405
Yes	7478 (49.5%)	7656 (50.7%)
No	7627 (50.5%)	7449 (49.3%)
Location, n (%)			<0.0001
Urban	14,143 (93.6%)	13,902 (92.0%)
Rural	962 (6.4%)	1203 (8.0%)
US geographic region, n (%)			0.5169
East	6884 (45.6%)	6970 (46.1%)
Central	5043 (33.4%)	5026 (33.3%)
West	3178 (21.0%)	3109 (20.6%)
Number of beds, n (%)			<0.0001
0–199	1641 (10.9%)	1549 (10.3%)
200–299	2414 (16.0%)	1843 (12.2%)
300–499	4560 (30.2%)	5090 (33.7%)
500 plus	6490 (43.0%)	6623 (43.8%)

Table 4. Results of clinical outcomes on propensity matched pairs (Floseal only vs. Floseal + gelatin/thrombin).

	Number of discordant pairs				McNemar statistic		p-Value
Cohort		FO = Yes F + G/T = No	FO = No F + G/T = Yes
Number of matched pairs		15,105	15,105
Intraoperative transfusions		209 (1.4%)	378 (2.5%)	48.66			<0.0001
Perioperative transfusions		238 (1.6%)	420 (2.8%)	50.34			<0.0001
Postoperative transfusions		248 (1.6%)	455 (3.0%)	60.95			<0.0001
Pure-blood/pRBC transfusions		353 (2.3%)	652 (4.3%)	88.96			<0.0001
Blood loss complications only		73 (0.5%)	115 (0.8%)	9.38			0.0022
Severe complications		89 (0.6%)	105 (0.7%)	1.32			0.2507
Other complications		54 (0.4%)	68 (0.5%)	1.61			0.2050

FO = Floseal Only; F + G/T = Floseal + Gelatin/Thrombin; pRBC = packed red blood cells.

Table 5. Results of healthcare resource utilization outcomes on propensity matched pairs (Floseal only vs. Floseal + gelatin/thrombin).

	Number of matched pairs	Mean difference (FO minus F + G/T)	95% Confidence interval	p-Value
Hospital length of stay (days)	15,105	−0.446	(−0.546, −0.347)	<0.0001
Surgery time (minutes)	14,927	−39.028	(−42.240, −35.815)	<0.0001
Hemostat volume (mL)	10,770	−12.514	(−12.985, −12.044)	<0.0001

FO = Floseal only; F + G/T = Floseal + gelatin/thrombin.