Abdominoplasty is one of the most popular esthetic procedures performed in
Brazil. A serious and potentially fatal complication of abdominoplasty is venous
thromboembolism (VTE). A systematic review by Hatef et al.1 demonstrated that the rate of VTE was 0.34% for
abdominoplasty-only patients, 0.67% for patients undergoing abdominoplasty with
a concomitant plastic surgery procedure, and 3.4% for patients undergoing
circumferential abdominoplasty. In a single institutional series, VTE was 5.0%
in abdominoplasty patients and 7.7% in circumferential abdominoplasty
Despite the relative frequency of this serious complication, opinion regarding
the preferred methods to prevent a VTE in abdominoplasty patients, including
chemoprophylaxis, remain controversial². The reasons for not incorporating
chemoprophylaxis may be the low rate of VTE when patients are properly selected,
limited depth and duration of anesthesia, properly positioning of patients,
mechanical prophylaxis, and early postoperative ambulation of patients ³.
Additionally, because VTE prophylaxis agents block portions of the coagulation
cascade to inhibit blood clot formation, the risk of bleeding complications is
theoretically increased. Prophylaxis for venous thromboembolism is recommended
for at least 10 days after high-risk surgeries. An inconvenience associated with
the use of low-molecular-weight heparin, is the need for continuous daily
injections up to 2 weeks, usually when the patient is recovering at home.
New oral regimens (rivaroxaban) could enable shorter hospital stays, with the
added benefit of more reliable prophylaxis4. Rivaroxaban (Xarelto) is an oral Factor Xa inhibitor. The
medication gained United States Food and Drug Administration (FDA) approval in
2011 for VTE prevention for patients undergoing hip or knee replacement surgery
and in 2013 in Brazil4.
At the standard prophylactic doses (10 mg once daily), measuring drug levels is
not necessary, and adjustments for weight or creatinine clearance are not
required. We present a retrospective experience of 1 single plastic surgeon on
the use of rivaroxaban for routine VTE prophylaxis in patients undergoing
abdominoplasty after massive weight loss.
A retrospective chart review was conducted on 396 patients who received
postoperative rivaroxaban (Xarelto) after having undergone an abdominoplasty.
All patients had previously undergone bariatric surgery. All procedures were
performed under general anesthesia. A dose of 10 mg of rivaroxaban was initiated
24 hours postoperatively. Since this drug was administered in abdominoplasty
patients, it was technically an off-label use as the Food and Drug
Administration (FDA) has approved rivaroxaban for VTE prophylaxis in hip and
knee replacement patients.
As the drug was approved for a related (but not identical) indication, a specific
formal written consent regarding its use following abdominoplasty was not
obtained. During routine consultation and consent for surgery, the patients were
informed regarding the risks and benefits associated with rivaroxaban, and were
notified about its off-label use. The study conformed to the World Medical
Association Declaration of Helsinki5.
All clinical and operative notes and laboratory data were utilized for data
collection. Data on demographics, comorbidities, body mass index (BMI), surgery
performed, length of anesthetic use, and postoperative complications were
recorded. Patients were included in the analysis if there was a follow-up of at
least 90 days.
In the present study, rivaroxaban was routinely administered to all
abdominoplasty patients as they were considered high risk based on the procedure
type as cited in the American Society of Plastic Surgeons (ASPS) VTE task force
recommendations (which utilized the 2005 Caprini scale), and was prescribed for
30 days6. The first dose was given 24
hours post-procedure. Four hours after the procedure, all patients received 40
mg of subcutaneous enoxaparina. We used enoxaparina because nausea and vomiting
are common complications after surgery and may compromise absorption of
rivaroxaban. Additional standard practices included prophylaxis using
perioperative sequential compression devices, early ambulation, and maintaining
Postoperative pain was managed with 400 mg of celecoxib (12/12 h for 7 days) and
30 mg of codeine (8/8 h for 5 days). Follow-up was done from the time of surgery
till 90 days post-operative. Patients smoking at preoperative visits (typically
within 4 weeks of surgery) were classified as smokers and were classified as
non-smokers if they reported a negative smoking history. Patients on
contraceptive medications or hormone replacement therapies in any form (pill,
cream, ring, intrauterine device, injection) at the preoperative visit were
classified as positive for contraceptive medications and were encouraged to
The chart review included 396 patients who underwent abdominoplasty from July
2015 to July 2018.. All patients had previously undergone a Roux-en-Y gastric
bypass (338 laparoscopic and 58 open approach). Gender distribution was uneven
with a predominance of females: 356 were female and 40 were male.
The ages of the patients ranged from 20 to 62 years. The mean age was 39.1 years.
The mean weight at the time of plastic surgery was 71.5 kg (48-145 kg). The mean
body mass index (BMI) prior to the weight loss surgery was 43.8 kg/m2 (range, 37.3-61.9 kg/m2) with a mean BMI of 27.2 kg/m2 (20.4-38.3 kg/m2) at the time of the abdominoplasty.
The mean dose of albumin for the patients was 4.0 mg/dl (3.1-4.5 mg/dl). The mean
hemoglobin was 12.7 g/dl and the GV was 38.6%. Among the comorbidities,
hypothyroidism was the most prevalent, present in 13 patients. Only 2 patients
had hypertension and none had diabetes mellitus. The mean dry abdominal flap
weight was 2.53 kg (0.9-14.0 kg). The mean surgical time was 134 minutes
(105-180) (Table 1).
Table 1 - Demographic Data.
|Mean age (years)
|Abdominal flap weight
Table 1 - Demographic Data.
There were other surgeries associated with the abdominoplasty in this series.
There were 260 (65.6%) conventional abdominoplasties and 136 (34.4%) anchor
abdominoplasties. Patients were discharged on the first postoperative day in
100% of the cases. Complications occurred in 29 (7.3%) patients: 13 patients had
hematomas (3.2%), the most frequent complication. Additional complications
included seroma formation with needle aspiration (n = 4.1%), 2 local infections
(infected seroma and cellulitis) and 6 cases of tissue necrosis of small
All cases of hematoma were operated in an outpatient setting without
hospitalization. Two patients who were allowed oral diet developed intestinal
obstruction between the second and third week. One case was clinically reversed,
while the other required laparotomy with flange release of the
whole-anastomosis. Both patients had uneventful sequelae.. There was no case of
deep vein thrombosis (VTE). One patient had a severe bronchospasm 24 hours after
surgery, but pulmonary thrombo-embolism (PTE) was discarded.
Out of the 396 patients who received postoperative rivaroxaban, 1 patient (0.25%)
had a PTE (Table 2). The patient was a
47-year-old woman with a BMI of 28, who had undergone a conventional
abdominoplasty. An ultrasound did not reveal a VTE but the CT scan revealed a
moderate-large clot burden affecting left pulmonary trunk and confirmed a PTE.
She was prescribed a therapeutic dose of enoxaparin, which was substituted with
a therapeutic dose of rivaroxaban (20 mg daily) for PTE treatment. She had an
Table 2 - Complications (POD).
|Hematoma with operative evacuation
|Seroma with needle aspiration
|Infections (including cellulitis)
Table 2 - Complications (POD).
The prevention of VTE is a high priority in esthetic surgery and has occupied an
increasingly large space in all medical specialties; countless protocols can be
found in literature. Although abdominoplasty is the most common esthetic
procedure associated with VTE, the mechanisms for the development of VTE
associated with this procedure are unclear7.
The term “venous thromboembolism” refers to a spectrum of diseases that include
deep venous thrombosis and pulmonary embolism. Pulmonary embolism is considered
to be a preventable cause of hospital death. Development of thromboembolism
involves the following stages: (1) venous stasis, (2) damage to vascular
endothelium, and (3) hypercoagulability. During surgery, all these stages are
exaggerated. The intraoperative immobilization and the precoagulant state after
surgical vascular injury toward the block of the surgical bleeding also act to
decrease fibrinolytic activity.
Grazer & Goldwyn8 reported a 1.1%
incidence of deep venous thrombosis and a 0.8% incidence of pulmonary embolism
in abdominoplasty. Similarly, Hester et al. found that when abdominoplasty was
combined with other surgical procedures, the incidence of pulmonary embolism was
A thorough patient history is essential to detect and determine risk. In our
casuistic, we have the risk factors of oral contraceptive use, hormone
replacement therapy, and a large number of previously obese (post bariatric
Ideally, chemoprophylaxis should be (1) effective at preventing VTE, (2)
associated with a low risk of adverse events such as hematoma formation, (3)
inexpensive, (4) without the need for monitoring levels or adjusting doses based
on weight or creatinine, (5) easily administered and tolerated by the patient,
and (6) administered as part of patient protocol without consulting a
Rivaroxaban is an orally bioavailable factor Xa inhibitor that selectively blocks
the active site of factor Xa and does not require a cofactor (such as Anti-
thrombin III) for activity. Rivaroxaban was approved for use in several
countries, by the European Medicine Agency in 2008, and by the FDA Therapeutics
and Clinical Risk Management in 20159.
Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic
pathways plays a central role in the cascade of blood. The maximum
concentrations of rivaroxaban appear 2 to 4 hours after tablet intake. The
pharmacokinetics of rivaroxaban were not affected by drugs which alter gastric
Administration of rivaroxaban via a method that could deposit drug directly into
the proximal small intestine (e.g., feeding tube) should be avoided as it can
result in reduced absorption and drug-related exposure. The effect lasts 8 to 12
hours; however, factor Xa activity does not return to normal within 24 hours, so
once- daily dosing is possible10.
Rivaroxaban has been demonstrated to be effective for VTE prophylaxis in patients
undergoing hip and knee replacement (initial FDA indications), and bleeding
rates were found to be similar to those with enoxaparin. The standard duration
of therapy is 14 days after knee replacement or 35 days after hip
replacement11,12. Rivaroxaban demonstrated cost saving in
patients with total hip and total knee replacements when compared to
The purpose of this article was to demonstrate that rivaroxaban is a safe
medication for thromboprophylaxis in patients undergoing abdominoplasty after
massive weight loss. After addition of rivaroxaban, all patients used elastic
compression stockings after surgery continuously for 1 month and were ambulatory
on the first day after surgery.
In this paper, the abdominoplasty patients included had an average age of were
39.1 years, average BMI was 27.2, and average operative time was 134 minutes.
This is not the first published study on rivaroxaban in abdominoplasty patients.
Dini et al.14 evaluated rivaroxaban for
postoperative VTE prophylaxis in abdominoplasty patients. In a prospective,
randomized, double-blinded, placebo controlled study, 40 patients considered
high risk were randomized to receive either rivaroxaban 10 mg or placebo daily
for 10 days. The drug was first administered 8 hours after surgery. After 27
surgeries, the study was stopped due to a high complication rate; it was noted
that all 8 hematomas up to that point had occurred in the study (rivaroxaban)
group. It is possible that early initiation of rivaroxaban could have been the
In our study, rivaroxaban was initiated 24 hours after surgery. We preferred to
use the subcutaneous enoxaparina 40 mg 4 hours after surgery, instead of
rivaroxaban 10 mg, because nausea and vomiting are common after the surgery and
may compromise the absorption of rivaroxaban.
No patient developed a VTE and 1 patient who developed a PTE (0.25%) in this
study was consistent with the incidence in literature. Plastic surgeons could be
interested in the fact that the patient developed symptoms of PTE 16 days after
surgery, and surgeons used prophylaxis at most 14 days. Hunstad et al.15 published that 1 patient developed VTE
(0.24%) in a multicenter study with 132 patients who underwent abdominoplasty
and received rivaroxaban postoperatively, similar to our study. Hustand et al.
administrated 10 mg of rivaroxaban for 7 days, which is not sufficient in our
opinion as most VTE events occur 10 days after surgery.
Regarding hematomas, Stewart et al.16
published their experience of 278 abdominoplasty patients and reported a 3%
hematoma rate. Out of 396 patients in this study, hematoma formation requiring
operative evacuation in 13 patients (3.2%) is acceptable, with all hematomas at
the abdominal site. When compared to reoperative hematoma rates in the plastic
surgery population, our use of rivaroxaban is consistent with previously
Studying 3681 patients who underwent a wide variety of surgical procedures,
Pannucci et al.17 reported an overall
reoperative hematoma rate of 2.65% when enoxaparin was not administered and
3.38% when enoxaparin was administered (not significant) in a study of 1567
patients at moderate to high risk for VTE events according to the 2005 Caprini
scale and 2114 matched historical control patients.
Regarding the 2 patients who developed intestinal obstruction (0.5%) between the
second and third week of oral diet, we believe that the higher intra-abdominal
pressure (owing the rectus muscle plication), associated with constipation could
be an explanation. Champion & Williams18,in 2003, demonstrated an overall incidence of intestinal
obstruction of 1.8% in a large series of laparoscopic gastric bypass
A potential limitation of our study is that since this study reports on a patient
series without a comparison group, we cannot make conclusions regarding
superiority or inferiority of rivaroxaban use for abdominoplasty patients with
respect to VTE prevention or complication rates.
The strength of this study is our inclusion of all consecutive patients during
our study period who took rivaroxaban with adequate follow-up for relevant
hematologic and surgical complications. In our experience, rivaroxaban has a low
rate of adverse events such as hematoma formation and is well tolerated by
patients without a large burden of cost.
The absence of symptomatic deep vein thrombosis and only one case of pulmonary
embolism do not allow any effective conclusion since the statistical sample was
small. However, this should open a fresh perspective for future studies in the
national and worldwide plastic surgery societies where large samples can be
obtained to prove the safety (or not) of rivaroxaban in deep vein thrombosis
prophylaxis for patients undergoing abdominoplasty after massive weight
Routine chemoprophylaxis with rivaroxaban for abdominoplasty after massive weight
loss patients has a low rate of VTE events. This oral medication is well
tolerated and has an acceptable complication profile.
Analysis and/or data interpretation, conception and design study,
data curation, final manuscript approval, formal analysis,
methodology, project administration, realization of operations
and/or trials, supervision, visualization, writing - review &
Final manuscript approval, formal analysis, writing - review &
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1. Medicina Privada, Curitiba, PR,
2. Universidade Federal do Paraná, Curitiba, PR,
Corresponding author: Guilherme Berto Roça, Rua
Emiliano Perneta 390, 7º ANDAR, CJ 707, Centro, Curitib, PR, Brazil. Zip Code
80420-080 . E-mail: email@example.com
Article received: October 29, 2018.
Article accepted: February 10, 2019.
Conflicts of interest: none.