Application of the Caprini Risk Assessment Model for Evaluating Postoperative Deep Vein Thrombosis in Patients Undergoing Plastic and Reconstructive Surgery

Journal Pre-proof Application of the Caprini Risk Assessment Model for evaluating postoperative deep vein thrombosis in patients undergoing plastic and reconstructive surgery Hiroki Yago, Takashi Yamaki, Yumiko Sasaki, Kento Homma, Takatoshi Mizobuchi, Yuki Hasegawa, Atsuyoshi Osada, Hiroyuki Sakurai PII:

S0890-5096(19)30937-9

DOI:

https://doi.org/10.1016/j.avsg.2019.10.082

Reference:

AVSG 4744

To appear in:

Annals of Vascular Surgery

Received Date: 22 March 2018 Revised Date:

2 September 2019

Accepted Date: 22 October 2019

Please cite this article as: Yago H, Yamaki T, Sasaki Y, Homma K, Mizobuchi T, Hasegawa Y, Osada A, Sakurai H, Application of the Caprini Risk Assessment Model for evaluating postoperative deep vein thrombosis in patients undergoing plastic and reconstructive surgery, Annals of Vascular Surgery (2019), doi: https://doi.org/10.1016/j.avsg.2019.10.082. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc.

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Original Article

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Application of the Caprini Risk Assessment Model for evaluating postoperative deep vein thrombosis in patients undergoing plastic and reconstructive surgery

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Hiroki Yago, Takashi Yamaki, Yumiko Sasaki, Kento Homma, Takatoshi Mizobuchi,

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Yuki Hasegawa, Atsuyoshi Osada, Hiroyuki Sakurai

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Department of Plastic and Reconstructive Surgery, Tokyo Women’s Medical University,

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Tokyo, Japan

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Corresponding author:

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Hiroki Yago,

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Department of Plastic and Reconstructive Surgery, Tokyo Women’s Medical University,

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8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

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Tel: +81-3-3353-8111

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Fax: +81-3-3225-0940

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E-mail: [email protected]

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Declarations of interest: none.

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1

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Abbreviations

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Abstract

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Objective: The optimal approach for assessing the risk of venous thromboembolism

25

(VTE) in patients undergoing plastic surgery is yet to be established. This study aimed

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to determine the validity of the Caprini Risk Assessment Scale in identifying patients

27

undergoing plastic surgery who are at a high risk of developing VTE.

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Methods: Between December 2014 and November 2015, we enrolled 90 patients. Risk

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factors for VTE were assessed at baseline. The Caprini Risk Assessment Model was

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used to stratify patients into Caprini <4, Caprini 5–6, Caprini 7–8, and Caprini >8

31

groups before examination. We preoperatively screened for deep vein thrombosis

32

(DVT) using duplex ultrasound. During operation, surgical duration and blood loss

33

were recorded. Duplex ultrasound was repeated 2 and 7 days postoperatively to

34

evaluate for DVT. We used a univariate analysis to determine risk factors for

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postoperative VTE. Confounding predictors were finally tested using a multivariate

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logistic regression analysis.

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Results: One patient had preoperative DVT and was excluded from the study.

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Eighty-nine patients were included in the final analyses. Of the 89 patients, 7 (8%)

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developed postoperative DVT. Mean age, body mass index, Caprini score, and surgical

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duration were significantly higher in patients who developed postoperative DVT.

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Variables associated with increased risk of postoperative DVT using univariate

42

analysis were Caprini scores of 7–8 and >8. Multivariate logistic regression analysis

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finally identified Caprini scores 7–8 [odds ratio (OR) 13, 95% confidence interval (CI)

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1.67–101.98, P =.014] and >8 (OR 19.5, 95% CI 1.02–371.96, P =.048) to be

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independently associated with postoperative DVT.

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Conclusions: Although the incidence of postoperative DVT is relatively low among

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patients undergoing plastic surgery, Caprini scores can be used to predict postoperative

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VTE complications.

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1. Introduction

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Recently, venous thromboembolism (VTE) has garnered much attention because of its

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potential to cause death during surgery. However, VTE in the field of plastic and

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reconstructive surgery has not been well examined. Therefore, we urge plastic surgeons

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worldwide to discuss the risk of VTE in their patients. It is difficult to stratify patients

56

as the risk varies relative to heterogeneous operation methods and surgical blood loss.

57

There are several reports of preoperative VTE risk assessment using the Caprini Risk

58

Assessment Model (RAM) in plastic and reconstructive surgery.1-3 (Table I)The

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American College of Chest Physicians (ACCP) guidelines for preventing VTE have

60

long been the gold standard for stratifying surgical patients into low-, moderate-, and

61

high-risk groups. Recent additions to the guidelines recommend using the Caprini

62

RAM for individual patients undergoing surgery.4 Using the Caprini RAM, Pannucci et

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al.2 found that the risk of developing VTE was 0.61% in patients with a Caprini score of

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3–4, 1.27% in those with a Caprini score of 5–6, 2.69% in those with a Caprini score of

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7–8, and 11.3% in those with a Caprini score of >8 60 d postoperatively. They

66

concluded that Caprini scores could predict the risk of postoperative VTE. However,

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because the clinical study involved a retrospective review of electronic charts and only

68

collected data on symptomatic patients, accurate predictors of deep vein thrombosis

69

(DVT) after plastic surgery remain uncertain. As even an isolated, asymptomatic calf

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VTE can cause severe pulmonary thromboembolisms5, identification of patients with

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asymptomatic DVT is critically important. Therefore, this study aimed to determine the

5

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validity of the Caprini RAM for identifying patients undergoing plastic surgery who are

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at a high risk of developing VTE.

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2. Materials and Methods

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For this prospective, single-centered study, we enrolled 90 patients between December

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2014 and November 2015. Patients’ preoperative characteristics, including age, sex,

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body mass index (BMI, kg/m2), and presence of active cancer, congestive heart disease,

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hormone replacement therapy, inflammatory bowel disease, central venous catheter

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placement, previous history of DVT, and renal failure were all evaluated. The Caprini

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RAM was used to classify patients into Caprini <4, Caprini 5–6, Caprini 7–8, and

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Caprini >8 groups before operation. The presence of DVT was preoperatively screened

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using duplex ultrasound.

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All patients used graduated thigh-high compression stockings, and a

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pneumatic compression device was intermittently applied during the operation. In this

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study, all patients used graduated compression stockings, and pneumatic compression

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devices were applied intermittently while patients were confined to bed. Although

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patients were encouraged to walk on postoperative day 1. They wore class II thigh-high

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stockings.Surgical duration and blood loss volume were recorded. Repeat duplex

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ultrasound examinations were performed 2 and 7 days postoperatively to evaluate for

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DVT. In this study, no patients were on prior anticoagulants or received prophylactic

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anticoagulants. The study protocol and informed consent form were approved by the

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local institutional review boards of the respective clinics.

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2. 1. Venous duplex ultrasound

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Compression ultrasound was used to detect the presence of DVT. A color duplex

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scanner (LOGIQ 7 PRO, GE Yokogawa Medical Systems, Tokyo, Japan) with a 5- to

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10-MHz transducer was used. Initially, each patient was in the reverse Trendelenburg

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position at 15°. Examinations were initiated at the external iliac vein, common femoral

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vein, and then moved to the femoral vein at the adductor canal. The anterior and

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posterior tibial veins were also examined. Subsequently, the patient was placed prone

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with the knee flexed at 30°, and the popliteal, peroneal, gastrocnemius, and soleal veins

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(SV) were examined. The diagnosis of DVT was based on both noncompressibility of

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the vein in B-mode and lack of spontaneous flow on color Doppler imaging. A

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diagnosis of iliofemoral DVT was established if the proximal veins showed venous

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thrombus extending proximally to the external iliac vein. A diagnosis of

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femoropopliteal DVT was established if the proximal veins showed thrombus without

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iliac involvement. Finally, a diagnosis of calf vein thrombosis was established if a

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thrombus was detected only in the calf veins.All venous duplex ultrasound

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examinations were performed by experienced clinical vascular technologists.

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The primary endpoint of this study was the development of DVT in the first seven days,

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as identified by compression ultrasound of the lower extremities, 2 and 7 days

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postoperatively. The secondary endpoint was the predictor of DVT.

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2.2. Statistical analysis

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All data were analyzed using the JMP Pro (Version 12.1, SAS Institute, Cary, North

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Carolina, USA). We made between-group comparisons using Student’s t test and used a

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Χ2 test to evaluate differences. Univariate analysis and multivariate logistic regression

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analysis were used to determine possible risk factors for postoperative VTE.

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Continuous data were expressed as mean ± standard deviation. Statistical significance

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was defined as P <.05.

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3. Results

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Ninety patients were enrolled. One patient was excluded, leaving 89 patients

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(49 males and 40 females) with a mean age of 58 years (range, 16–85 years), who were

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eligible for the study (Fig.1). All cases were performed under hospitalization.

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The average length of a hospital stay for study patients was 5 days.Among the 89

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patients surgical procedures included surgical funnel chest correction using pectus bar

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(n = 30), surgical flaps (n = 17; 15 free flaps and 2 pedicled flaps), stripping (n = 7),

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scar revision (n = 7), benign tumor removal (n = 6), lymphaticovenous anastomosis for

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lymphedema (n = 5), tissue expander insertion (n = 3), breast implant insertion (n = 3),

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skin grafting (n = 3), facial bone fixation (n = 2), and “other” operations (n = 6). We

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were doing stripping operations for patients with primary varicose veins for 3-day

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admission. Now, less invasive endovenous laser ablations are performed for these

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patients on an ambulatory basis. Seven (7.9%) patients had postoperative DVT. The

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distribution of postoperative DVT is shown in Table II. DVT was detected in five

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patients 2 days postoperatively, and isolated SV thrombosis was detected in two

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patients 7 days postoperatively. Table III shows that the procedures performed on the 7

8

141

patients who suffered a DVT.
In this study, 12 patients who underwent free flap

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transfer had cancer resection.

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No patient developed symptomatic DVT, and no further VTE-related complications

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were encountered during the follow-up period.

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Table IV shows the baseline results grouped according to the presence or

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absence of postoperative DVT. There were no significant differences in mean age, BMI,

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or sex distribution between patients with DVT and without. Regarding risk factors for

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DVT, significant differences in mean age (P =.01), BMI (P =.04), Caprini risk

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assessment score (P =.01), or surgical duration (P = 0.03) were observed in patients

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who developed DVT.

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Table V shows the relationship between Caprini score and the presence or

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absence of DVT. To analyze this relationship, patients were stratified into Caprini ≤4

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(low risk), Caprini 5–6 (moderate risk), Caprini 7–8 (high risk), and Caprini >8 (highest

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risk) groups. Eighty-seven percent of patients were classified as Caprini ≤4, and none

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of these patients developed DVT. DVT was detected only in patients with a Caprini

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score of >5.

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To identify risk factors for postoperative DVT, we transformed continuous data

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elements including age, BMI, sex, surgical duration, and Caprini score into categorical

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data. Age was categorized into <40, 40–59, and ≥60 years. BMI was categorized into

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<18.5, 18.5–24.9, 25.0–29.9, and ≥30 kg/m2. Surgical duration was categorized into

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<60, 60–119, and ≥120 min. Caprini scores were categorized into 2, 3–4, 5–6, 7–8, and

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>8 points. Initial risk factors were tested by univariate analysis (Table VI ). Variables

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associated with the greater risk factors for postoperative DVT were Caprini scores of

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164 165 166

7–8 (P =.006) and >8 (P =.025). Multivariate logistic regression analysis finally revealed that Caprini scores of 7–8 [odds ratio (OR) 13, 95% confidence interval (CI) 1.67–101.98, P =.014] and >8

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(OR 19.5, 95% CI 1.02–371.96, P =.048) were independently associated with

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postoperative DVT (Table VII).

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4. Discussion

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At first we select the Caprini score because of its usefulness in patients who underwent

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plastic and reconstructive surgery. It is difficult to stratify patients as the risk varies

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relative to heterogeneous operation methods in plastic and reconstructive surgery. There

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are several reports of preoperative VTE risk assessment using the Caprini Risk

175

Assessment Model (RAM) in plastic and reconstructive surgery. The American College

176

of Chest Physicians (ACCP) guidelines for preventing VTE have long been the gold

177

standard for stratifying surgical patients into low-, moderate-, and high-risk groups.

178

Recent additions to the guidelines recommend using the Caprini RAM for individual

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patients undergoing surgery.We think caprini score is very easy to use by anyone in

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plastic and reconstructive surgery. We need some laboratory data if we use Roger's

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score . But we don't need it to use caprini score.In addition because we cover lots of

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ground of surgery, It is not usefull to stratify patients by operation type in Roger's score.

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This study investigated the relationship between preoperative variables and the

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development of DVT after plastic and reconstructive surgery. Although there was no

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statistical significance, patients who underwent lengthy free-flap operations tended to

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develop DVT. However, postoperative DVT was also detected among patients who

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underwent short-duration surgeries, including skin grafting and facial bone fixation. In

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this study, Caprini scores of ≥7 were significantly associated with higher DVT

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incidence. Other risk factors, such as age, sex, BMI, or surgical duration, were not

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independently associated with postoperative DVT.

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ACCP guidelines propose group VTE prophylaxis with “risk of symptomatic

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VTE” and “risk and consequences of major bleeding complications” (i.e., “average

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risk” and “high risk or severe consequences,” respectively). Risk of symptomatic VTE

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is classified as “very low,” “low,” “moderate,” and “high-risk” in these guidelines.4,6 As

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per these guidelines, the majority of patients undergoing plastic and reconstructive

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surgeries are considered to have an average risk of bleeding complications. The Caprini

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RAM calculates an individualized risk assessment score on the basis of the presence or

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absence of VTE risk factors. In addition, this model’s ability to predict VTE risk has

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been validated for patients undergoing general, urologic, and vascular surgery.7-9

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Pannucci et al. used the Caprini RAM to determine the risk of developing

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postoperative VTE in patients undergoing plastic and reconstructive surgery.2 They

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reported that a Caprini score of >8 was associated with increased risk of VTE compared

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with patients with a Caprini score of 3–4 (OR 20.9, P <.001), 5–6 (OR 9.9, P <.001) or

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7–8 (OR 4.6, P =.015).

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VTE prophylactic measures include mechanical and chemical methods that are

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assigned from risk stratification.10-19 The risk of wound hematoma on

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chemoprophylaxis ranges from 0.5% to 1.8% in patients undergoing plastic and

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reconstructive surgeries.4,20-23 A meta-analysis of bleeding complications in general

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surgery patients showed that hematoma requiring a second operation occurred in only

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210 211

1% of patients.24 Pannucci et al.2 completed a retrospective study of 1,126 plastic and

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reconstructive patients. Inclusion criteria were a Caprini score of ≥ 3, surgery under

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general anesthesia, and postoperative hospital admission. Patients who received

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chemoprophylaxis were excluded. Dependent variables included symptomatic DVT or

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pulmonary embolism (PE) within the first 60 days postoperatively and time to DVT or

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PE. Overall DVT incidence was 1.26% and overall PE incidence was 0.89%. Patients

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with both DVT and PE comprised 0.44% of the total number of patients. VTE incidence

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increased dramatically with increased Caprini score. Approximately one in nine (11.3%)

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patients with a Caprini score of >8 had a VTE event. Patients with Caprini score >8

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were significantly more likely to develop VTE when compared to patients with Caprini

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score of 3-4 (OR 20.9, p<0.001), 5-6 (OR 9.9, p<0.001), or 7-8 (OR 4.6, p=0.015).

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Additionally, patients with Caprini score 7-8 were significantly more likely to develop

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VTE when compared to patients with Caprini score 3-4 (OR 4.5, p=0.04)

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Pannucci et al.6 also investigated postoperative enoxaparin for preventing

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symptomatic VTE in plastic surgery patients, based on Caprini RAM. In that study,

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patients with a Caprini score of ≥3 received postoperative enoxaparin prophylaxis

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starting 6–8 hours after surgery and continued chemophylaxis for the duration of their

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inpatient stay. Control patients who underwent surgery between 2006 and 2008 did not

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receive chemoprophylaxis for 60 d after the surgery. The primary study outcome was

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symptomatic 60-day VTE in 3,334 (1,876 controls and 1,458 enoxaparin patients)

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patients. Notable risk reduction was observed in patients with Caprini scores of >8

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(8.54% vs. 4.07%, P =.182) and 7–8 (2.55% vs. 1.15%, P =.230) who received

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233 234 235

postoperative enoxaparin. Logistic regression was limited to the highest-risk patients (Caprini ≥ 7) and demonstrated that a length of stay (LOS) of ≥4 days (adjusted OR 4.63, P =.007) and Caprini score of >8 (OR 2.71, P =.027) were independent predictors

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of VTE. In high-risk plastic surgery patients, postoperative enoxaparin prophylaxis is

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protective and LOS of ≥4 days is also an independent risk factor for VTE.3

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The Caprini RAM was developed more than a decade ago, and several

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modifications of the model have been validated in surgical patients. Because of the

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unavailability or high cost associated with the original Caprini scoring paradigm, Bilgi

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et al.25 excluded expensive lab parameters including factor V Leiden, serum

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homocysteine, anti-cardiolipin antibodies, prothrombin 20210A, and

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lupus-anticoagulant, only including the clinical criteria. Using this adapted Caprini

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score, they found that the risk of developing VTE was significantly higher among

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patients undergoing elective or emergency surgery, those under regional or general

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anesthesia, and those with a Caprini score of >8. They concluded that the adapted

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Caprini score was an economical, practical, and effective tool for assessing

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perioperative VTE risk in surgical patients.25

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Because previous studies only included data concerning symptomatic patients,

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we included asymptomatic DVT patients who underwent plastic and reconstructive

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surgery. In the present study, patients with a Caprini score of ≥7 were more likely to

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develop VTE than those with a Caprini score of <7. Although there was no statistical

253

significance (P =.627), DVT was found in three patients with a Caprini score of 5–6.

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DVT was also found in patients undergoing skin graft or facial bone fixation,

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previously considered low-risk patients.

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Similarly, Konoeda et al.26 reported that chemoprophylaxis should be

256 257

considered in patients undergoing breast reconstruction with a Caprini score of >5,

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regardless of operative procedures, as VTE complications were not noted in patients

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undergoing breast construction with a Caprini score of <4. Pannucci et al.5 reported that among high-risk plastic surgery patients with a

260 261

Caprini score of ≥7, postoperative enoxaparin prophylaxis protects against a 60-day

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VTE risk. Patients with a Caprini score of >11 can be identified as a subgroup of

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patients at extremely high risk. These patients need a more effective prophylactic

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regimen.27 At this moment, few investigators have found the usefulness of the

265 266

intraoperative venous ultrasound in the prediction of postoperative DVT. Melnyk et al

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report as a case report that intraoperative venous ultrasound is low-cost and rapid

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assessment tool and played a crucial role in both making a rapid diagnosis and altering

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patient management. 28More investigations are needed to validate a use of intraoperative

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venous ultrasound for DVT detection. This study was limited by its small sample size, which may have introduced a

271 272

potential for type II statistical error. Future studies should include a larger cohort of

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surgical patients. Additionally, our follow-up period was relatively short. Recent studies

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have demonstrated that VTE risk may remain substantially elevated for at least 90 days

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after surgery.29 Despite these limitations, we believe that our findings have important

276

implications for perioperative VTE prophylaxis in the field of plastic and reconstructive

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surgery.

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Although the incidence of postoperative DVT is relatively low among patients

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undergoing plastic and reconstructive surgery, Caprini scores can be used to predict

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possible postoperative thromboembolic complications. Because most plastic and

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reconstructive surgery patients are at average risk for bleeding complications during

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chemoprophylaxis, it should be considered in patients with a Caprini score of ≥7.

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5. Conclusions

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Our results indicate that the Caprini RAM effectively risk-stratifies patients with plastic

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and reconstructive surgeries for postoperative DVT risk.

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6. Acknowledgments

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7. Funding

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This research did not receive any specific grant from funding agencies in the public,

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commercial, or not-for-profit sectors.

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Legends Figure 1. Study flow diagram Ninety patients were enrolled and 89 patients were eligible for inclusion in the study. Of the 89 patients evaluated, 7 (7.9%) had postoperative DVT. DVT was detected in five patients 2 d postoperatively, and isolated soleus venous thrombosis was detected in two patients 7 d postoperatively.

Tables Table I. Caprini Risk Assessment Model

Table II. Distribution of postoperative DVT Distribution of DVT

Postoperative day 2

Postoperative day 7

n = 5 patients

n = 5 patients

Iliofemoral DVT

0

0

Femoropopliteal DVT

0

0

PV+SV

0

0

PTV alone

0

0

SV alone

5

2

Calf DVT

DVT; deep vein thrombosis, PTV; posterior tibial vein, PV; peroneal vein, SV; soleal vein

Table III. The procedures performed on the 7 patients who suffered a DVT.

Case

Diagnosis

Surgical procedure

Caprini score

Postoperative DVT POD 2

POD 7

1

breast cancer

Deep inferior epigastric perforator flap

5

Positive

Negative

2

decubitus

Split thickness skin graft

11

Positive

Positive

3

cancer of the maxillary sinuses

Vascularized scapular osteocutaneous flap with subscapular vessels

7

Positive

Positive

4

breast cancer

Deep inferior epigastric perforator flap

7

Positive

Positive

5

zigomatic bone fracture

Open reduction and internal fixation

7

Positive

Positive

6

breast cancer

Latissimus dorsi musculocutaneous flap

5

Negative Positive

7

breast cancer

Free perforator flap

5

Negative Positive

DVT; deep vein thrombosis

Table IV.Baseline characteristics grouped by presence or absence of postoperative DVT

DVT
 


No DVT
 


n = 7 patients

n = 82 patients

p value

Demographic data Mean age (years)

58.38 ± 14.75

40.07 ± 19.39

0.01

BMI (kg/m2)

23.20 ± 2.63

21.31± 3.88

0.04

6.75 ± 1.98

3.0 ± 1.8

0.01

Surgical duration

7.46 ± 4.93

2.89 ± 2.96

0.03

Blood loss

147.6 ± 160.3

47.6 ± 107.29

0.24

Caprini risk assessment score Risk factors for DVT associated with operation

DVT; deep vein thrombosis; BMI, body mass index

Table V. The relationship between Caprini score and the presence or absence of DVT Low score

Moderate

High score

Highest

(≤4)

score (5–6)

(7–8)

score (≤8)

DVT (−)

71(86.6%)

16(19.5%)

2(2.4%)

1(1.2%)

82

DVT (+)

0

3(43%)

2(28.5%)

2(28.5%)

7

DVT; deep vein thrombosis;

total

Table VI. The relationship between patient characteristics and the presence or absence of DVT p value DVT
 No DVT
 
 
 n = 7 patients

n = 82 patients

<40

2

41

0.276

40–59

3

24

0.453

≤60

2

18

0.687

<18.5

2

19

0.747

18.5–24.9

3

49

0384

25–29.9

2

12

0.331

≤30

0

2

0.676

4

45

0.908

<60 min

1

9

0.790

60–119 min

2

31

0.627

≤120 min

4

42

0.763

<2

2

40

0.304

3–4

0

21

0.126

5–6

2

17

0.627

7–8

2

3

0.006

>8

1

1

0.025

BMI

Male sex Surgical duration

Caprini score

BMI, body mass index

Table VII. The result of a multivariate logistic regression analysis. Caprini

Wald

Odds ratio

95% CI

P-value

7–8

6.002

13

1.67–101.98

0.014

>8

3.899

19.5

1.02–371.96

0.048

score

CI, confidence interval

90 patients were enrolled

Preoperative DVT (+)

Preoperative DVT (−)

1 patient

89 patients

Postoperative day 2 Postoperative day 2 DVT (−) 84 patients DVT (+) 5 patients

Postoperative day 7

Postoperative day 7

DVT (+)

DVT (−)

2 patients

82 patients

Fig.1 Study flow diagram