Cost-consequence analysis of different active flowable hemostatic matrices in cardiac surgical procedures

Figures & data

Table 1. Clinical inputs.

Clinical outcomes	FLOSEAL	SURGIFLO	Risk Ratio/Adjusted Ratio	p-value	Data source
Average surgery time per surgery (min)^b	375	439	1.2^b	<.001^c	Tackett et al.^2 Table 2
Average volume per surgery (mL)	9.0	9.7	1.9	.008	Supplemental analysis of dataset
Major complications (%)^a	4.5%	9.1%	2.0^a	.001^c	Adjusted % from supplemental analysis;
Stroke	18.3%	18.3%	—		RR from Tackett et al.^2 Table 2
Shock	25.4%	25.4%	—
Sepsis	4.8%	4.8%	—
Myocardial Infarction	32.5%	32.5%	—
Combination of ≥2	19.0%	19.0%	—
Minor complications (%)^a	23.2%	35.7%	1.5^a	<.001^c	Adjusted % from supplemental analysis;
Renal Failure	28.5%	28.5%	—		RR from Tackett et al.^2 Table 2
Respiratory Insufficiency	33.3%	33.3%	—
Inotropic support lasting >24 h	13.5%	13.5%	—
Combination of ≥2	24.7%	24.7%	—
Surgical revision (%)^a	3.9%	7.5%	1.9^a	.042^c
Blood product transfusions (%)^a	52.0%	84.3%	1.6^a	<.001^c

^a Risk ratios were derived from odds ratios from logistic regressions for binary outcomes.

^b Adjusted ratio and means were derived from GLM-negative binomial distribution with log link.

^c Indicates a significant difference between the groups (p < .05).

Table 2. Cost inputs—surgery-related costs.

Surgery-related costs	Cost	ICD-9-CM procedure code or secondary diagnosis code	Source
Product cost for average surgical case			Ave mL from Tackett et al.^2, FLOSEAL WAC,
Using FLOSEAL	$381	—	SURGIFLO ASP.
Using SURGIFLO	$183	—
Cost of operating room time for average case			Ave mins from Tackett et al.^2, OR cost/min
Using FLOSEAL	$9,000	—	from Chatterjee et al.^19
Using SURGIFLO	$10,536	—
Cost of cardiac surgery (CABG, valve surgery, thoracic aortic surgery, no complication)	$38,486	36.10–36.19, 35.1–35.28, 35.31, 35.32, 35.33, 35.39, 38.45	2012 NIS^18 dataset
With blood product transfusion (without complication,  without revision)	$43,117	99.00, 99.02-99.05
With revision (without complication, without blood product transfusion)	$57,332	34.03
Cost of cardiac surgery with major complications^a			2012 NIS^18 dataset
With stroke	$58,351	434–434.99, 436, 433.x1, 997.00, 997.01, 997.02, 997.09
With shock	$50,472	785.50, 785.59, 998.0, 998.00.998.01. 998.02. 998.09
With sepsis	$67,449	995.91, 995.92, 38.0, 38.01, 38.1, 38.19. 38.2, 38.4, 38.41, 38.42, 38.43, 38.44, 38.49. 38.8, 38.9
With myocardial infarction (MI)	$46,580	410.x0, 410.x1
With ≥2 combined major complications	$71,871	—
Cost of cardiac surgery with minor complications^a			2012 NIS^18 dataset
With renal failure	$48,618	586, 584–584.9, 399.5
With respiratory insufficiency	$46,119	786.09, 518.81, 518.82, 518.5
With inotropic support (>24 h)	$47,038	428.0, 428.1, 428.2, 428.20, 428.21, 428.22, 428.23, 428.9 (low output syndrome)
With ≥2 combined minor complications	$61,281	—

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

^a Costs reported for major and minor complications assume cardiac surgery base cost without blood product transfusion or surgery revision.

Figure 1. Estimated net cost impact of using FLOSEAL vs SURGIFLO in an average US hospital performing 245 cardiac surgical procedures per year.

Figure 2. One-way sensitivity analysis results.

Figure 3. PSA for net cost savings.

Table A1. Probability distributions for clinical inputs.

Parameter	Base estimate	Probability distribution
Average number of cardiac surgical procedures per year	245	Fixed
Surgery time for FLOSEAL (min)	375	Log normal
Surgery time ratio, FLOSEAL v. SURGIFLO	1.17	Log normal
Major complications
% Major complications, FLOSEAL	0.0453	Logistic normal
Major complications ratio, FLOSEAL v. SURGIFLO	2.01	Log normal
Stroke rate, FLOSEAL	0.183	Dirichlet*
Shock rate, FLOSEAL	0.254
Sepsis rate, FLOSEAL	0.048
MI rate, FLOSEAL	0.325
Combined major complications, FLOSEAL	0.190
Stroke rate, SURGIFLO	0.183	Dirichlet*
Shock rate, SURGIFLO	0.254
Sepsis rate, SURGIFLO	0.048
MI rate, SURGIFLO	0.325
Combined major complications, SURGIFLO	0.190
Minor complications
% Minor complications, FLOSEAL	0.232	Logistic normal
Minor complications ratio, FLOSEAL v. SURGIFLO	1.54	Log normal
Renal failure, FLOSEAL	0.285	Dirichlet*
Respiratory insufficiency, FLOSEAL	0.333
Inotropic support, FLOSEAL	0.135
Combined minor complications, FLOSEAL	0.247
Renal failure, SURGIFLO	0.285	Dirichlet*
Respiratory insufficiency, SURGIFLO	0.333
Inotropic support, SURGIFLO	0.135
Combined minor complications, SURGIFLO	0.247
Surgical revisions
% Cardiac surgery cases requiring surgical revision, FLOSEAL	0.0388	Logistic normal
Ratio of cardiac cases requiring surgical revision, FLOSEAL vs SURGIFLO	1.94	Log normal
Blood product transfusions
% Cardiac surgery cases requiring blood product transfusions, FLOSEAL	0.5203	Logistic normal
Ratio of cardiac cases requiring blood product transfusions, FLOSEAL vs SURGIFLO	1.62	Log normal

* Specific major and minor complication rates always totaled 100% and were simulated together using Dirichlet distribution.

Table A2. Probability distributions for cost inputs.

Parameter	Base estimate	Probability distribution
FLOSEAL average volume per surgery	8.955	Log normal
Ratio of volume per surgery (SURGIFLO/FLOSEAL)	1.084	Log normal
FLOSEAL cost per mL	42.58	Normal
SURGIFLO cost per mL	18.88	Normal
Cost of cardiac surgery, without complication, without revision, without blood product transfusion	38,486	Gamma
Cost of cardiac surgery, without complication, with revision, without blood product transfusion	57,332	Normal for incremental cost
Cost of major complications
Cost of surgery with stroke	58,351	Normal for incremental cost
Cost of surgery with shock	50,472	Normal for incremental cost
Cost of surgery with sepsis	67,449	Normal for incremental cost
Cost of surgery with MI	46,580	Normal for incremental cost
Cost of surgery with combined major complications	71,871	Normal for incremental cost
Cost of minor complications
Cost of cardiac surgery with renal failure	48,618	Normal for incremental cost
Cost of cardiac surgery with respiratory insufficiency	46,119	Normal for incremental cost
Cost of cardiac surgery with inotropic support (> 24 h)	47,038	Normal for incremental cost
Cost of cardiac surgery with combined minor complications	61,281	Normal for incremental cost
Cost of cardiac surgery with blood product transfusion, without complication, without revision	43,117	Normal for incremental cost
Cost of OR time (per 15 min)	462	Normal

Figure A1. PSA—clinical outcomes.

Tackett S, Calcaterra D, Magee G, et al. Real world outcomes of hemostatic matrices in cardiac surgery. J Cardiothorac Vasc Anesth 2014;28:1558-65

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Chatterjee A, Payette MJ, Demas CP, et al. Opportunity cost: a systematic application to surgery. Surgery 2009;146:18-22

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2012 Healthcare Cost and Utilization Project’s (HCUP’s) National Inpatient Sample (NIS) Database. https://www.hcup-us.ahrq.gov/databases.jsp. Accessed February 10, 2016

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