At Plastic Surgery 2015 The Meeting, over 500 surgeons were present for the panel entitled “Thunderdome: VTE Prophylaxis and Body Contouring. What is the Evidence?” This panel was held in the main session, and the stellar attendance hints at plastic surgeons’ interest in venous thromboembolism risk stratification and prevention. This topic has been an explicit research priority for organized plastic surgery, including the American Society of Plastic Surgeons, the American Association of Plastic Surgeons, and the Plastic Surgery Foundation since 2008, when the American Society of Plastic Surgeons convened their “Partners in Quality Leadership Summit: Assessing the Impacts of DVT and the Surgeon General’s Call to Action in Plastic Surgery” in Chicago. This article attempts to summarize the current literature surrounding the risks and benefits of venous thromboembolism risk stratification and prophylaxis, and to incorporate existing guidelines and consensus statements from the American Society of Plastic Surgeons and the American Association of Plastic Surgeons and current research.
SCOPE OF THE PROBLEM
Venous thromboembolism is estimated to kill over 100,000 people in the United States each year. To put this number in better context, venous thromboembolism kills more people annually than the combination of motor vehicle crashes and breast cancer combined.1,2 Venous thromboembolism is frightening because it can strike quickly and be rapidly fatal. In fact, among patients who present with symptomatic pulmonary embolus, 10 percent will be dead within 60 minutes. Approximately 5 percent of patients with pulmonary embolus ultimately develop cardiac dysfunction in the form of right heart strain, in some cases proceeding to right heart failure.3,4
Patients with deep vein thrombosis without pulmonary embolus may still have lifelong ramifications. Vessel wall inflammation that accompanies acute deep vein thrombosis can terminally damage the wall and the venous valves, predisposing patients to chronic venous reflux and the postthrombotic syndrome. Postthrombotic syndrome is known to be an independent predictor of poor quality of life after deep vein thrombosis5 and, like post–pulmonary embolus cardiac dysfunction, can be a lifelong condition. Finally, patients diagnosed with venous thromboembolism have a risk of venous thromboembolism recurrence of 3 percent per year for the rest of their life.6 They are also labeled as “high risk” for any surgical procedure moving forward, and may in some surgeons’ eyes no longer be candidates for elective operations.
Venous thromboembolism is a clear threat to the safety of plastic surgery patients.7–11 The rate of venous thromboembolism in the overall inpatient population is 1.2 percent. However, some patients have 60-day venous thromboembolism risks of over 8.5 percent.11 The rate of postoperative death in over 1 million office-based plastic surgery patients is low (0.002 percent). However, in that series, pulmonary embolus was the cause of death in over 50 percent of patients who died, and was most commonly associated with abdominoplasty.8 Arnold and colleagues note that “given that DVT is often clinically silent and pulmonary embolus may be rapidly fatal, prevention is the most effective strategy to reduce the burden of VTE.”12 The U.S. Surgeon General, the Joint Commission, and the American College of Chest Physicians agree that venous thromboembolism prevention is the key to minimizing morbidity and mortality from venous thromboembolism.13–16 This CME article provides plastic surgeons with an evidence-based approach to venous thromboembolism risk stratification and prevention.
VENOUS THROMBOEMBOLISM IN PLASTIC SURGERY
The Plastic Surgery Foundation identified venous thromboembolism as a research priority in 2009 and subsequently funded the multicenter Venous Thromboembolism Prevention Study. The American Society of Plastic Surgeons convened its Venous Thromboembolism Task Force in 2009 and published its official guidelines in 20129 (Level of Evidence: Therapeutic, V). More recently, the American Association of Plastic Surgeons performed a systematic review and meta-analysis of venous thromboembolism risk stratification and the risks and benefits of chemoprophylaxis specific to the plastic surgery population10 (Level of Evidence: Therapeutic, V).
Recent literature has addressed the misconception that plastic surgery patients are all at low risk for perioperative venous thromboembolism events. In fact, an 18-fold variation in venous thromboembolism risk exists among the overall plastic and reconstructive surgery population. Existing literature in plastic surgery often presents patient groups in aggregate, without considering individual levels of risk. As the majority of plastic surgery patients are at low risk, this practice floods the denominator and masks a distinct, high-risk subgroup of patients11,17–21 (Reference 11 Level of Evidence: Therapeutic, III). Factors such as anesthetic type, surgical procedure, and the patient’s baseline risk for venous thromboembolism (including a personal or family history of venous thromboembolism) are all known to alter venous thromboembolism risk.10,17 Individual risk stratification allows surgeons to consider these risk factors at the patient level.
2005 Caprini Risk Assessment Model
The most recent American College of Chest Physicians guidelines22 support individualized risk stratification, where a patient’s personal characteristics (e.g., age, body mass index, and personal or family history of venous thromboembolism) are used to conceptualize and quantify their venous thromboembolism risk. Several individualized risk-stratification tools have been developed for both inpatient23–26 and outpatient21 surgical populations.
The 2005 Caprini score23 is the most widely used and well-validated individualized risk-stratification tool. The 2005 Caprini score has face validity among surgical patients in general, having been validated to predict risk in general/vascular/urology,27 gynecology oncology,28 otolaryngology–head and neck surgery,29 thoracic surgery,30 spine surgery,31 and patients in the surgical intensive care unit.32 The Caprini score has been validated in international surgical populations as well.31,33,34 The 2005 Caprini score has been studied in multiple plastic surgery articles11,17,35–37 and identifies an 18-fold variation in venous thromboembolism among the overall patient population.17 The 2010 Caprini score, which disproportionately weights operative time and body mass index, has been shown to inflate a patient’s perceived risk scores, which results in less rigorous risk stratification.36 Thus, current American Society of Plastic Surgeons and American Association of Plastic Surgeons recommendations are explicitly for the 2005 version of the Caprini Risk Assessment Model9,10 (Fig. 1).
Risk factors and protective factors that may be relevant but are not included in a 2005 Caprini score include recent air or car travel (including plastic surgery tourism), rectus plication, anesthetic type, timing and extent of early ambulation, and inpatient versus outpatient surgery. Length of follow-up for venous thromboembolism has not been standardized between studies. Although venous thromboembolism outcomes at 30 or 60 days are typically provided, the United Kingdom Million Women Study showed that venous thromboembolism risk remains elevated for at least 12 weeks and possibly up to 1 year after inpatient or outpatient surgery.38
Risk stratification using a 2005 Caprini score predicts 60-day venous thromboembolism risk among plastic and reconstructive surgery inpatients,17 and completion of a 2005 Caprini score is recommended by the 2012 American Society of Plastic Surgeons Task Force guidelines to conceptualize and quantify venous thromboembolism risk. However, risk stratification should be used in concert with, not instead of, clinical judgment. For example, a 39-year-old woman with a body mass index of 24 who presents for abdominoplasty consultation and has four first-degree relatives with venous thromboembolism would have a 2005 Caprini score of 5 (three points for family history and two for planned operative time >45 minutes). Given her notable family history, this score may underestimate her risk.
Inpatient versus Outpatient Surgery
The United Kingdom Million Women Study (which included data for 947,454 women) clearly demonstrated that both inpatient surgery and outpatient surgery increase venous thromboembolism risk. Venous thromboembolism incidence was higher among inpatient surgery compared with outpatient surgery. Relative risk for venous thromboembolism rose sharply after surgery and peaked at 3 weeks. Relative risk for venous thromboembolism at 3 weeks was 110-fold over baseline for inpatients, and 10-fold over baseline for outpatients. For both inpatient and outpatient surgery, risk remained increased for at least 12 weeks after surgery.38
The majority of data on venous thromboembolism risk stratification and prophylaxis are from the inpatient population. However, breast cancer reconstructive operations, postbariatric body contouring, complex upper extremity and hand, and aesthetic operations are routinely performed in ambulatory surgery centers; high-risk patients certainly exist among the overall outpatient surgery population.18,19,35,37 A prior study of 173,501 surgical patients from the National Surgical Quality Improvement Program database demonstrated a 19-fold variation in venous thromboembolism risk among the overall outpatient surgery population. It is worth noting that the highest risk cohort had a 30-day venous thromboembolism risk of 1.18 percent, and the lowest risk cohort had a 0.06 percent 30-day venous thromboembolism risk.21 Ultimately, the majority of data presented in this article are derived from the inpatient plastic surgery population. However, all patients (including those having inpatient and outpatient surgery) would benefit from individualized risk stratification to better conceptualize their venous thromboembolism risk, with risk modification and risk reduction being performed at the surgeon’s discretion.
The 2005 Caprini score has not previously been validated among the outpatient surgery population, although there is no conceptual reason why it would predict risk differently between these two populations. As such, the 2012 American Society of Plastic Surgeons Venous Thromboembolism Task Force recommends that surgeons “should consider completing” a 2005 Caprini score or a similar risk model to conceptualize and quantify venous thromboembolism risk among outpatient surgery patients, as opposed to a “should complete” recommendation for inpatient surgery patients.9
Procedure-Specific Risks, Including Abdominoplasty
Although many authors submit that abdominoplasty is the surgical procedure that places patients at highest venous thromboembolism risk, this is not supported by the literature. Using a procedure-specific designation, 0.3 to 0.6 percent of abdominoplasty patients have a postoperative venous thromboembolism.18,39–41 In contrast, patients having free flap breast reconstruction have a venous thromboembolism rate as high as 3.4 percent,42 and head and neck cancer patients who require reconstruction have a venous thromboembolism rate as high as 26 percent.43 A recent systematic review and meta-analysis did not demonstrate that procedure type predicted venous thromboembolism risk or response to chemoprophylaxis.9
The 2005 Caprini score should be used as a “jumping-off” point to conceptualize and quantify venous thromboembolism risk. Procedure-specific risk factors do exist, and have been incorporated into procedure-specific venous thromboembolism risk-assessment models.18,44 Many of these procedure-specific risks are not incorporated into a 2005 Caprini score. Risk factors specific to individual operative procedures are beyond the scope of this CME article. However, one example worth discussing is procedure-specific risk factors for the abdominoplasty population. Several studies have shown that abdominal wall plication in abdominoplasty45,46 and transverse rectus abdominis musculocutaneous flap breast reconstruction47,48 can increase intraabdominal pressure. Increased intraabdominal pressure is known to create lower extremity venous stasis and venous dilation,49,50 which in turn can create intimal microtears that provide a nidus for clot formation.51 In addition to plication, bed flexion to facilitate Scarpa fascia and skin closure may provide an additional increase in intraabdominal pressure.46,52 Postoperative abdominal binders may further increase intraabdominal pressure,46,52 and unmodified compression garments and binders52,53 can create a tourniquet effect on the upper thighs, further decreasing lower extremity venous outflow.
A concerted effort to incorporate individual risk stratification into everyday clinical practice is essential: only by asking the questions can we truly elucidate risk. Caprini notes that family history of venous thromboembolism is the most commonly missed risk factor,23,54 likely because surgeons fail to discuss it explicitly. Similarly, estrogen-based contraceptives, particularly the discrete vaginal contraceptive rings, may not be mentioned by patients.55
Prior work in plastic surgery and other specialties has demonstrated that an increased 2005 Caprini score predicts perioperative venous thromboembolism risk. Thus, reduction in Caprini score through risk modification may decrease the risk for venous thromboembolism. This concept of risk modification applies to elective surgery patients whose operation can safely be delayed while risk factors are addressed. It also applies to the surgeon’s decision-making process in terms of what procedures to perform, and which concurrent procedures can be performed safely. It does not apply to urgent operative procedures that cannot safely be delayed.
A careful examination of the 2005 Caprini score (Fig. 1) shows that the surgeon can potentially modify many of the 40 risk factors before surgery. These risk factors include obesity, oral contraceptive use, recent (<30 days) operative procedure, central venous line (such as chemotherapy ports for breast cancer patients), and others. When these risk factors are identified, surgeons can delay elective operative procedures to optimize (lower) the patient’s risk for venous thromboembolism. For example, estrogen-based contraceptives, including vaginal rings, can be stopped 4 weeks before surgery and restarted 4 weeks after surgery to reduce Caprini score and decrease venous thromboembolism risk. However, for patients already at low risk for venous thromboembolism based on a Caprini score, a slight reduction in Caprini score (e.g., from 4 to 3, or from 6 to 5) may not substantially decrease their venous thromboembolism risk.
Combined procedures increase venous thromboembolism risk,19,39,40,56,57 although whether this is from increased operative time (also a known risk factor)13,58 or more extensive surgical injury remains to be determined. Well-designed studies using 1.4 million cases from the National Surgical Quality Improvement Program database have shown a clear relation between increased operative time and venous thromboembolism risk.13 Similarly, anesthesia type represents a modifiable risk factor for venous thromboembolism. General anesthesia, and particularly paralysis, may predispose patients to lower extremity venous stasis by removing the beneficial action of the calf muscle pump.59–62 The American Association of Plastic Surgeons Consensus Statement explicitly recommended that surgeons consider nongeneral anesthesia, as a pooled analysis showed that nongeneral anesthesia significantly reduced venous thromboembolism risk.10 At present, there are no controlled studies that identify the optimal type of nongeneral anesthetic for venous thromboembolism risk reduction.63
Hypercoagulable Workup and Hematology Consultation
The plastic surgery literature10,11 supports sequential compression devices and chemoprophylaxis for high-risk patients, as stratified by the 2005 Caprini score. However, some patients have an incredibly strong family history of venous thromboembolism or recognized personal hypercoagulable states not completely characterized by a 2005 Caprini score. When high-risk patients are identified, surgeons may choose to refer these patients preoperatively for hematology consultation. Among a large cohort of free flap reconstruction patients with hypercoagulability, preoperative referral to hematology showed a trend toward improved flap outcomes,64 although whether this could similarly decrease venous thromboembolism rates has not been studied.
For patients at particularly high risk, surgeons may obtain preoperative hematology consultation to better understand their perioperative venous thromboembolism risk. Hematologists can be invaluable for hypercoagulability workups and assistance with perioperative venous thromboembolism risk modification and chemoprophylaxis.65 The results of standard hypercoagulability workup are often uninterpretable in the setting of recent surgery and receipt of chemoprophylaxis. Thus, preoperative, as opposed to postoperative, hematology consultation is ideal. Ultimately, the surgeon may also decide that a patient’s venous thromboembolism risk is too high to safely undergo an operative procedure. For these patients, the decision to offer an operation represents the last bastion of modifiable risk factors.
Although data for “extended duration” chemoprophylaxis (generally, 28 to 35 days, including postdischarge prophylaxis) exist for hip and knee replacement patients, urology patients, and abdominal and pelvic cancer patients,66,67 there is no standard of care regarding chemoprophylaxis duration for plastic surgery patients. Hematology consultation can aid plastic surgeons in this decision process as well.
VENOUS THROMBOEMBOLISM PREVENTION
Elastic compression stockings are known to be more effective than no stockings for venous thromboembolism prevention.68 However, the recent American Association of Plastic Surgeons consensus guidelines preferentially recommend sequential compression devices over elastic compression stockings for two reasons. Sequential compression devices can affect two limbs of Virchow’s triad (stasis and hypercoagulability), as they work by means of both a mechanical method (recreation of the calf muscle pump to minimize stasis) and a fibrinolytic mechanism (by stimulating the body’s endogenous fibrinolytic system).51,69 Elastic compression stockings can affect one limb of Virchow’s triad (stasis) by shunting blood from the superficial to the deep system.68,70 More importantly, a recent meta-analysis demonstrated that sequential compression devices were superior to elastic compression stockings for venous thromboembolism risk reduction.71 The combination of sequential compression devices plus elastic compression stockings versus elastic compression stockings alone has not been studied. Combination prophylaxis, which refers to the combination of sequential compression devices and chemoprophylaxis, has been shown to be more beneficial for venous thromboembolism risk reduction than either sequential compression devices or chemoprophylaxis alone.72,73
Risk stratification has been shown to predict not only baseline risk for venous thromboembolism among plastic surgery patients17 but also response to prophylaxis.10,74 This discussion focuses on enoxaparin, a low-molecular-weight heparin, and the newer oral factor Xa inhibitors (such as rivaroxaban or apixaban), as the vast majority of recent plastic surgery–centric data and interest involves these medications.
Rivaroxaban and apixaban have current U.S. Food and Drug Administration approval for stroke reduction in nonvalvular atrial fibrillation and deep vein thrombosis and pulmonary embolus prophylaxis after adult hip or knee replacement. Rivaroxaban is also indicated for treatment of established venous thromboembolism.75,76 These medications are not explicitly approved for venous thromboembolism prevention among plastic surgery patients. Several studies have been published examining their safety profile. Dini et al.77 published an aborted randomized controlled trial of 27 patients, in which a very high rate (six of 14 patients) of reoperative hematoma was seen in patients randomized to rivaroxaban (G. Dini, personal e-mail communication with the American Association of Plastic Surgeons consensus panel group, February of 2015). Incidentally, Dini and colleagues used nonsteroidal antiinflammatory drugs concomitant with rivaroxaban; the combination is known to increase bleeding compared with rivaroxaban alone.78 More recently, Hunstad et al. published a case series of 132 patients who received an oral factor Xa inhibitor after abdominoplasty for venous thromboembolism prophylaxis. Their observed rate of reoperative hematoma was 2.3 percent.79 Although oral factor Xa inhibitors may be safe for plastic surgery patients, their effectiveness remains to be proven for venous thromboembolism prevention.
Enoxaparin has been studied extensively in the plastic surgery population. Enoxaparin is administered subcutaneously, generally once per day at a dose of 40 mg. Prior single-center studies, conducted in moderate- to high-risk patients, have shown that enoxaparin is effective for venous thromboembolism risk reduction.19,20 Existing studies support that enoxaparin prevents venous thromboembolism among high-risk patients (2005 Caprini scores of 7 to 8 or >8). Specifically, the Venous Thromboembolism Prevention Study (n = 3334) demonstrated a 50 percent relative risk reduction and absolute risk reductions of 4.5 percent for patients with a 2005 Caprini score of greater than 8 and 1.4 percent for patients with a 2005 Caprini score of 7 to 8 (Fig. 2). This study also showed in a multivariable regression that postoperative enoxaparin was protective against venous thromboembolism in high-risk patients (OR, 0.39; 95 percent CI, 0.16 to 0.97) (Table 1).11
The recent American Association of Plastic Surgeons systematic review and meta-analysis explicitly recommends against chemoprophylaxis in the overall plastic surgery population, as there was no evidence of a benefit but there was evidence of harm. Instead, the American Association of Plastic Surgeons guidelines recommend prophylaxis based on individual risk level, and specifically recommend chemoprophylaxis for patients with Caprini scores greater than 8.10 The American Society of Plastic Surgeons recommendations note that surgeons “should strongly consider” chemoprophylaxis for patients with 2005 Caprini scores of 7 or greater, and “should consider” use of chemoprophylaxis for patients with 2005 Caprini scores of 3 to 6.9 Thus, in the authors’ opinion, current evidence supports provision of chemoprophylaxis for plastic surgery patients with 2005 Caprini scores of 7 to 8 and for patients with 2005 Caprini scores greater than 8. The Venous Thromboembolism Prevention Study provided chemoprophylaxis for the duration of inpatient stay only. There is no current standard for duration of chemoprophylaxis in plastic surgery patients.
When chemoprophylaxis is provided, there is no evidence in the plastic surgery literature that preoperative or intraoperative chemoprophylaxis is superior for venous thromboembolism risk reduction.10 Thus, current data support the safety and effectiveness of postoperative administration of venous thromboembolism chemoprophylaxis, with initiation at 6 to 8 hours after surgery and continuation for the duration of inpatient stay only11,80 (Reference 80 Level of Evidence: Therapeutic, II).
Several articles in the plastic surgery and relevant literature have imaged asymptomatic patients to identify asymptomatic venous thromboembolism. Studies have shown variable rates of asymptomatic postoperative venous thromboembolism, ranging from 0.5 percent in outpatient aesthetic surgery,81 to 3.4 percent in microsurgical breast reconstruction,42 to 26.3 percent in head and neck cancer patients with simultaneous reconstruction.43 Although vocal advocates for screening duplex ultrasound exist in plastic surgery,81,82 this opinion is not mainstream. Ultimately, the author believes that screening duplex ultrasound of plastic surgery patients may be a useful adjunct for research studies under institutional review board approval, but should not routinely be performed as a part of clinical care. This is especially true, in the author’s opinion, when screening duplex is used instead of chemoprophylaxis. The author’s viewpoint is supported by the American College of Chest Physicians’ 2012 guidelines, which explicitly recommend against duplex ultrasound screening of asymptomatic patients, including high-risk patients after traumatic injury or abdominal/pelvic cancer surgery.22 This is because the clinical benefit derived from identification of asymptomatic deep vein thrombosis remains unknown.
Bleeding and Chemoprophylaxis
Perceived risk for bleeding is the dominant concern cited by plastic surgeons who do not provide chemoprophylaxis to high-risk patients.83 Increased bleeding has been demonstrated in operations with large areas of dissection, such as postbariatric body contouring, or surgery in highly vascular areas, such as the face. Hatef et al. previously showed a statistically significant increase in transfusion (6.6 percent versus 0.9 percent) and hematoma (7.3 percent versus 0.5 percent) among body contouring patients who received an aggressive chemoprophylaxis strategy: all patients received enoxaparin either preoperatively or intraoperatively or within 2 hours of the conclusion of surgery.19 Durnig and Jungwirth reported a 16.2 percent reoperative hematoma rate in facial rhytidectomy surgery, again using an aggressive chemoprophylaxis strategy including low-molecular-weight heparin 2 hours before surgery.84 The Venous Thromboembolism Prevention Study examined reoperative hematoma at four centers for 3681 patients who received enoxaparin prophylaxis started 6 to 8 hours after surgery.80 Multivariable regression showed that microsurgical procedure, breast surgery, and postbariatric body contouring were independent predictors of reoperative hematoma. When controlling for these and other factors, receipt of postoperative enoxaparin was not a predictor of reoperative hematoma (OR, 1.16; 95 percent CI, 0.77 to 1.76) (Table 2). Of note, if patients with postoperative bleeding are identified, the effects of unfractionated heparin and enoxaparin can be reversed by protamine.
Larger studies, including three meta-analyses10,74,85 and the Plastic Surgery Foundation–funded Venous Thromboembolism Prevention Study,80 have shown that chemoprophylaxis likely increases rates of reoperative hematoma by less than 1 percent, and observed differences were statistically significant in a minority of these studies. In a 2007 Plastic and Reconstructive Surgery editorial, Davison and Massoumi discussed the relative balance between bleeding and venous thromboembolism. They remind us that bleeding can almost always be fixed, but death cannot: “a hematoma is a medical stress, an inconvenience, an embarrassment, or [necessitates] an additional procedure, but rarely does it kill a patient. Thromboembolism that progresses to a pulmonary thromboembolism kills the patient 50 percent of the time.”86
This CME article provides an evidence-based summary of venous thromboembolism risk stratification and prevention in plastic and reconstructive surgery patients. An evidence-based recipe for venous thromboembolism prevention is shown in Figure 3. A step-by-step approach to venous thromboembolism risk stratification and prophylaxis decisions is shown in Videos 1 through 4. (See Video, Supplemental Digital Content 1, which demonstrates risk stratification and plan to minimize venous thromboembolism risk for a breast cancer patient having a contralateral breast reduction. This video is available in the “Related Videos” section of the full-text article on PRSJournal.com or at http://links.lww.com/PRS/C4. See Video, Supplemental Digital Content 2, which demonstrates risk stratification and plan to minimize venous thromboembolism risk for a patient who requires a lower extremity skin graft. This video is available in the “Related Videos” section of the full-text article on PRSJournal.com or at http://links.lww.com/PRS/C5. See Video, Supplemental Digital Content 3, which demonstrates risk stratification and plan to minimize venous thromboembolism risk for a lower extremity trauma patient who requires free tissue transfer. This video is available in the “Related Videos” section of the full-text article on PRSJournal.com or at http://links.lww.com/PRS/C6. See Video, Supplemental Digital Content 4, which demonstrates risk stratification and plan to minimize venous thromboembolism risk for a breast cancer patient with a personal history of venous thromboembolism having reconstruction with free flaps. This video is available in the “Related Videos” section of the full-text article on PRSJournal.com or at http://links.lww.com/PRS/C7.)
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