| Literature DB >> 26604807 |
Derek Martyn1, Lisa M Meckley1, Gavin Miyasato1, Sangtaeck Lim2, Jerome B Riebman3, Richard Kocharian3, Jillian G Scaife1, Yajing Rao1, Mitra Corral2.
Abstract
BACKGROUND: Adjunctive hemostats are used to assist with the control of intraoperative bleeding. The most common types are flowables, gelatins, thrombins, and oxidized regenerated celluloses (ORCs). In the US, Surgicel(®) products are the only US Food and Drug Administration-approved ORCs.Entities:
Keywords: blood transfusion; health care costs; hemostatic techniques; hemostatics; surgical blood loss
Year: 2015 PMID: 26604807 PMCID: PMC4642806 DOI: 10.2147/CEOR.S88698
Source DB: PubMed Journal: Clinicoecon Outcomes Res ISSN: 1178-6981
Adjunctive hemostat products and classes
| Products and categories | Manufacturer |
|---|---|
| ORCs | |
| Surgicel® Original | Ethicon, Inc. (Somerville, NJ, USA) |
| Surgicel Nu-Knit® | Ethicon, Inc. |
| Surgicel SNoW™ | Ethicon, Inc. |
| Surgicel Fibrillar® | Ethicon, Inc. |
| Surgicel®, not otherwise specified | Ethicon, Inc. |
| Flowables | |
| Floseal® | Baxter Healthcare Corporation (Hayward, CA, USA) |
| Surgiflo® | Ethicon, Inc. |
| Vitasure® | Stryker Corporation (Malvern, PA, USA) |
| Flowables, not otherwise specified | Unspecified |
| Gelatin | |
| Gelfoam® | Pfizer, Inc. (New York, NY, USA) |
| Surgifoam® | Ethicon, Inc. |
| Gelatin powder | Multiple brands |
| Gelatin, not otherwise specified | Unspecified |
| Thrombin | |
| Evithrom® | Ethicon, Inc. |
| Recothrom® | ZymoGenetics, Inc. (Seattle, WA, USA) |
| Thrombi-Gel® | Pfizer, Inc. |
| Thrombi-Pad® | Pfizer, Inc. |
| Thrombin, not otherwise specified | Unspecified |
Abbreviation: ORCs, oxidized regenerated celluloses.
Figure 1Distribution of adjunctive hemostat use by type of surgical procedure.
Abbreviations: ORCs, oxidized regenerated celluloses; OAHs, other adjunctive hemostats; CABG, coronary artery bypass grafting; CEA, carotid endarterectomy; Cholecyst, cholecystectomy; Hyster, hysterectomy; Prostat, prostatectomy; AV, arteriovenous.
Baseline post-PSM cohort characteristics
| Cardiovascular
| Carotid endarterectomy
| Cholecystectomy
| Hysterectomy
| |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ORC | OAH | ORC | OAH | ORC | OAH | ORC | OAH | |||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | |
| Age (mean) | 65.5 | – | 64.2 | – | 70.7 | – | 70.7 | – | 59.3 | – | 59.9 | – | 49.5 | – | 49.5 | – |
| Male | 7,631 | 67% | 7,935 | 70% | 3,157 | 58% | 3,110 | 57% | 1,506 | 49% | 1,489 | 49% | 0 | 0% | 0 | 0% |
| Ethnicity | ||||||||||||||||
| Caucasian | 8,636 | 76% | 8,760 | 77% | 4,593 | 84% | 4,604 | 85% | 2,151 | 71% | 2,158 | 71% | 3,079 | 66% | 3,046 | 65% |
| African American | 1,351 | 12% | 1,294 | 11% | 269 | 5% | 268 | 5% | 258 | 8% | 263 | 9% | 840 | 18% | 851 | 18% |
| Hispanic | 43 | <1% | 40 | <1% | 18 | <1% | 15 | <1% | 49 | 2% | 45 | 1% | 68 | 1% | 79 | 2% |
| Other | 1,329 | 12% | 1,265 | 11% | 565 | 10% | 558 | 10% | 587 | 19% | 579 | 19% | 687 | 15% | 698 | 15% |
| Comorbidity | ||||||||||||||||
| Any malignancy | 539 | 5% | 523 | 5% | 248 | 5% | 232 | 4% | 347 | 11% | 375 | 12% | 987 | 21% | 938 | 20% |
| Metastatic solid tumor | 14 | <1% | 27 | <1% | 5 | <1% | 3 | <1% | 92 | 3% | 115 | 4% | 272 | 6% | 253 | 5% |
| Diabetes | 4,610 | 41% | 4,705 | 41% | 1,896 | 35% | 1,939 | 36% | 810 | 27% | 809 | 27% | 518 | 11% | 527 | 11% |
| Obesity | 2,317 | 20% | 2,345 | 21% | 553 | 10% | 527 | 10% | 650 | 21% | 649 | 21% | 843 | 18% | 839 | 18% |
| Cerebrovascular disease | 1,228 | 11% | 1,163 | 10% | 5,434 | 100% | 5,433 | 100% | 76 | 2% | 95 | 3% | 29 | 1% | 35 | 1% |
| Peripheral vascular | 4,275 | 38% | 4,133 | 36% | 1,290 | 24% | 1,365 | 25% | 233 | 8% | 205 | 7% | 27 | 1% | 22 | 0% |
| disease | ||||||||||||||||
| Renal disease | 2,725 | 24% | 2,704 | 24% | 642 | 12% | 713 | 13% | 602 | 20% | 617 | 20% | 139 | 3% | 127 | 3% |
| Hypertension | 9,023 | 79% | 9,048 | 80% | 4,562 | 84% | 4,541 | 83% | 1,809 | 59% | 1,748 | 57% | 1,545 | 33% | 1,555 | 33% |
| Congestive heart failure | 3,051 | 27% | 2,972 | 26% | 512 | 9% | 496 | 9% | 319 | 10% | 353 | 12% | 72 | 2% | 60 | 1% |
| Myocardial infarction | 3,394 | 30% | 3,516 | 31% | 744 | 14% | 683 | 13% | 187 | 6% | 214 | 7% | 55 | 1% | 48 | 1% |
| Chronic pulmonary disease | 3,453 | 30% | 3,248 | 29% | 1,347 | 25% | 1,384 | 25% | 566 | 19% | 556 | 18% | 488 | 10% | 483 | 10% |
| Pre-existing bleeding conditions | ||||||||||||||||
| 0 | 7,203 | 63% | 7,147 | 63% | 4,508 | 83% | 4,474 | 82% | 2,100 | 69% | 2,099 | 69% | 3,816 | 82% | 3,861 | 83% |
| 1 | 2,423 | 21% | 2,489 | 22% | 663 | 12% | 687 | 13% | 546 | 18% | 537 | 18% | 751 | 16% | 717 | 15% |
| 2 | 1,117 | 10% | 1,076 | 9% | 199 | 4% | 197 | 4% | 250 | 8% | 241 | 8% | 78 | 2% | 74 | 2% |
| 3+ | 616 | 5% | 647 | 6% | 75 | 1% | 87 | 2% | 149 | 5% | 168 | 6% | 29 | 1% | 22 | <1% |
| Census region | ||||||||||||||||
| Northeast | 2,335 | 21% | 2,013 | 18% | 561 | 10% | 494 | 9% | 433 | 14% | 405 | 13% | 824 | 18% | 844 | 18% |
| Midwest | 1,717 | 15% | 1,772 | 16% | 1,307 | 24% | 1,233 | 23% | 769 | 25% | 727 | 24% | 845 | 18% | 860 | 18% |
| South | 6,148 | 54% | 6,517 | 57% | 3,044 | 56% | 3,110 | 57% | 1,140 | 37% | 1,192 | 39% | 2,496 | 53% | 2,461 | 53% |
| West | 1,159 | 10% | 1,057 | 9% | 533 | 10% | 608 | 11% | 703 | 23% | 721 | 24% | 509 | 11% | 509 | 11% |
| Bed size | ||||||||||||||||
| <200 | 287 | 3% | 287 | 3% | 412 | 8% | 433 | 8% | 522 | 17% | 498 | 16% | 583 | 12% | 583 | 12% |
| 200–400 | 4,657 | 41% | 4,657 | 41% | 2,431 | 45% | 2,388 | 44% | 1,046 | 34% | 1,176 | 39% | 1,967 | 42% | 2,035 | 44% |
| >400 | 6,415 | 56% | 6,415 | 56% | 2,602 | 48% | 2,624 | 48% | 1,477 | 49% | 1,371 | 45% | 2,124 | 45% | 2,056 | 44% |
| Location | ||||||||||||||||
| Urban | 10,408 | 92% | 10,337 | 91% | 4,534 | 83% | 4,531 | 83% | 2,772 | 91% | 2,735 | 90% | 4,220 | 90% | 4,249 | 91% |
| Rural | 951 | 8% | 1,022 | 9% | 911 | 17% | 914 | 17% | 273 | 9% | 310 | 10% | 454 | 10% | 425 | 9% |
| Affiliation | ||||||||||||||||
| Teaching | 5,902 | 52% | 5,902 | 52% | 2,084 | 38% | 2,167 | 40% | 1,114 | 37% | 1,109 | 36% | 1,920 | 41% | 1,946 | 42% |
| Non-teaching | 5,457 | 48% | 5,457 | 48% | 3,361 | 62% | 3,278 | 60% | 1,931 | 63% | 1,936 | 64% | 2,754 | 59% | 2,728 | 58% |
Notes:
P-value <0.05. Presence of statistically significant differences for sex, individual comorbidities, location, and affiliation were determined by z-test; differences for ethnicity, pre-existing bleeding conditions, census region, and bed size were determined by chi-square test.
Abbreviations: ORCs, oxidized regenerated celluloses; OAHs, other adjunctive hemostats; PSM, propensity score matching; n, number of patients.
Figure 2Hemostat units/discharge and total hemostat cost.
Notes: All differences between OAHs and ORCs for mean units/discharge total hemostat costs (US$) were considered statistically significant at the P<0.001 level. Costs for hemostatic agent classes included all hemostats used.
Abbreviations: ORCs, oxidized regenerated celluloses; OAHs, other adjunctive hemostats.
LOS, total procedure cost (US$), transfusion rate, and 30-day readmissions: ORCs compared to OAHs
| Cardiovascular | Carotid endarterectomy | Cholecystectomy | Hysterectomy | |
|---|---|---|---|---|
| LOS | ||||
| OAHs | 9.3 | 3.0 | 8.1 | 3.1 |
| ORCs | 9.5 | 2.7 | 7.1 | 3.4 |
| | 0.948 | <0.001 | <0.001 | <0.001 |
| Total procedure cost | ||||
| OAH | $37,784 | $11,282 | $23,656 | $11,033 |
| ORCs | $39,019 | $10,580 | $20,309 | $10,898 |
| | 0.003 | <0.001 | <0.001 | 0.542 |
| Mortality | ||||
| OAHs | 2% | <1% | 3% | <1% |
| ORCs | 2% | <1% | 2% | <1% |
| | 0.467 | 0.654 | 0.137 | 0.297 |
| Transfusion rate during hospital stay | ||||
| OAHs | 43% | 5% | 19% | 14% |
| ORCs | 44% | 4% | 16% | 13% |
| | 0.124 | <0.001 | <0.001 | 0.303 |
Abbreviations: ORCs, oxidized regenerated celluloses; OAHs, other adjunctive hemostats; LOS, length of stay.