Hospital economic impact from hemostatic matrix usage in cardiac surgery

Figures & data

Table 1. Study end-points and results among patients with intra-operative bleeding10.

Clinical outcomes	FLOSEAL group (n = 110)	Comparator group^a (n = 104)	p value
Hemostasis Time (min), M (SD)^b	32.1 ± 5.4	56.3 ± 8	<0.001^c
Major complications^d	13 (11.8%)	18 (17.3%)	0.34
Stroke	15.4%	11.1%
Shock	23.0%	22.2%
Sepsis	23.1%	22.2%
Myocardial infarction	23.1%	27.8%
Combined (2 or more)	15.4%	16.7%
Minor complications^d	23 (20.9%)	35 (33.6%)	0.04^c
Renal failure	21.7%	22.9%
Respiratory insufficiency	30.4%	31.4%
Inotropic support, less than 24 h	34.8%	34.3%
Combined (2 or more)	13.1%	11.4%
Revision for bleeding	5 (4.5%)	14 (13.5%)	0.04^c
Transfusion of blood products	28.2%	60.6%	<0.001^c

^aComparator group was composed of 60.2% SURGICEL Nu-Knit and 39.8% GELFOAM.

^bHemostasis time is defined as the operative time from decannulation to closure of the sternum.

^cIndicates a significant difference among groups (p < 0.05).

^dClinical outcomes by group for individual major and minor complications were recorded in the study and provided by personal communication with study investigators.

SD, Standard deviation.

Table 2. Model cost inputs.

Surgery-related costs (including cost of surgery)	Cost	ICD-9-CM procedure code or secondary diagnosis code
CABG, valve surgery, thoracic aortic surgery, no complication	$43,176	36.10, 35.1–35.28, 35.31, 35.32, 35.33, 35.39, 38.45
With revision, no complication	$67,703	34.03, 39.41
With stroke	$60,026	434–434.99, 436, 433.x1
With shock	$63,062	785.50, 785.59
With sepsis	$106,774	995.91, 995.92
With MI	$54,962	410.x0, 410.x1
With combined major complications (2 or more)	$97,600	–
With renal failure	$61,348	586, 584–584.9
With respiratory insufficiency	$60,916	786.09, 518.81, 518.82, 518.5
With inotropic support >24 h	$53,193	428.9 (low output syndrome)
With combined minor complications (2 or more)	$100,889	–

CABG, coronary artery bypass grafting; h, hour; ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; MI, myocardial infarction; USD, US dollars.

Table 3. Annualized clinical and economic consequences for a single hospital with 600 cardiac surgeries per year.

Consequences	Clinical outcomes (number avoided)	Economic outcomes (cost savings)
Major complications*	33 events	$1.07M
Minor complications	76 events	$1.43M
Surgical revisions for bleeding	54 events	$1.32M
Blood transfusions	194 events	$1.21M
Operating room time	242 hours	$0.35M

*Difference in rate of major complications between FLOSEAL group and comparator group was not found to be statistically significant in the trial outcomes.

Figure 1. Sensitivity analysis results.

Table 4. Model variant scenario analyses, presenting varying case loads, regional adjustments, and clinical outcomes, on the resultant cost consequence.

Variant #	Annual case load	Geographic location	Variable inputs	Resultant cost consequence
1	600	National average	–	$5.38M
2	600	New York City, NY	–	$6.69M
3	375	Minneapolis, MN	Excluding major complications	$2.86M
4	100	Lafayette, LA	Reduction of 75% of surgical revisions, and excluding major complications	$0.58M

Nasso G, Piancone F, Bonifazi R, et al. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg 2009;88:1520-6

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