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Perioperative Venous Thromboembolism

KristenA.Ban, StefanD.Holubar, andDanielL.Clarke-Pearson

Background

Epidemiology

Perioperative venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), remains an important source of morbidity and mortality following pelvic surgery [1]. There is also signicant cost associated with a VTE event, with each inpatient VTE event associated with an estimated $32,000 in added costs [2]. The Center for Medicare and Medicaid Services (CMS) considers VTE a “never event” and penalizes hospitals for higher-than-expected VTE complications following specic procedures [3].

The incidence of perioperative VTE is estimated between <1% and 29% following pelvic surgery overall, with incidence varying depending on the indication for surgery and procedure performed [4, 5]. Surgery for pelvic organ prolapse carries a low risk of VTE, 0.2% for all approaches, with the highest risk in patients undergoing an abdominal approach with concur-

rent hysterectomy (0.7%) [6]. Pelvic surgery for malignancy and inammatory bowel disease carries the highest risk with incidence of 4–12% [7,

8]. The incidence of VTE in cancer patients

undergoing surgery without chemoprophylaxis was previously measured at 29% but is lower in the era of routine VTE chemoprophylaxis [5]. VTE rates following surgery for gynecologic malignancy range from 3% for cervical cancer up to 38% for ovarian cancer [9]. The risk of VTE is also elevated in patients undergoing pelvic surgery for inammatory bowel disease, with ulcerative colitis having the highest incidence [8, 10]. The incidence of VTE following proctectomy is highest for ulcerative colitis (UC) patients at

3.2% followed by Crohn’s disease (CD) at 1.5% and lowest for malignancy (1.4%) [11].

VTE events are the most common preventable cause of 30-day mortality in patients undergoing surgery for malignancy [12]. Notably, many postoperative VTE events occur after discharge from the hospital. One third of VTE events following oncologic surgery occur after discharge and an even higher proportion occur following discharge after surgery for pelvic organ prolapse [6, 13].

K. A. Ban (*) · S. D. Holubar Department of Colon & Rectal Surgery, Cleveland Clinic, Cleveland, OH, USA e-mail: bank4@ccf.org; holubas@ccf.org

D. L. Clarke-Pearson Department of Obstetrics & Gynecology, University of North Carolina, Chapel Hill, NC, USA e-mail: daniel_clarkepearson@med.unc.edu

https://doi.org/10.1007/978-3-031-66772-5_1

Risk Factors

General risk factors for VTE in addition to indication for surgery include older age, higher body mass index (BMI), inpatient hospitalization after

K. A. Ban et al.

surgery, American Society of Anesthesiologists (ASA) Classication 3 or 4, prolonged operative time, preoperative renal failure, and chronic steroid use [4, 6, 14]. Important risk factors include prior history of VTE (especially “unprovoked”) and known clotting disorders. Preoperative Hematology or Vascular Medicine referral for thrombophilia testing and perioperative management should be considered [15].

Estrogen-based contraception or therapy and tamoxifen treatment are also important modiable preoperative risk factors in women [16–19]. Oral combined hormonal menopausal therapy was associated with the highest risk of VTE in the nonsurgical population [19].

In the IBD population, surgery-specic risk factors for postoperative VTE include open surgery, emergency surgery, corticosteroids, malnutrition, functional status, ileostomy creation, and others [8, 14]. Patients with anemia, bleeding disorders, and bleeding are a particularly at-risk group as they often have their chemoprophylaxis held. Preoperative hospitalization was also shown to be a risk factor in a dose-dependent manner [20]. VTE risk in the perioperative period can be assessed with a validated measure such as the Caprini score, but this measure is relatively insensitive within sub-populations such as IBD or gynecologic cancer [21–23]. The Caprini score considers age, gender, type of surgery, comorbidities, venous disease, and clotting disorder risk. Most pelvic surgery is considered “Major” according to the Caprini score denition of more than 45min under anesthesia or any surgery with a laparoscopic approach.

Prevention

A variety of modalities are employed to prevent perioperative VTE [Fig. 1.1]. Early mobilization after surgery, mechanical prophylaxis with compression stockings and/or sequential compression devices (SCDs), and chemoprophylaxis are all thromboprophylaxis interventions [1]. Most, if not all, of these modalities are routinely included in perioperative care pathways like enhanced recovery after surgery (ERAS) protocols [24]. Extended chemoprophylaxis following discharge from the hospital is also selectively employed to decrease VTE events in high-risk populations [13, 25].

Chemoprophylaxis

Chemoprophylaxis refers to the prevention of VTE with administration of medication. Acceptable chemoprophylaxis agents include subcutaneous unfractionated heparin and lowmolecular weight heparin (enoxaparin) as well as oral agents like apixaban and rivaroxaban. In the immediate postoperative period, subcutaneous agents are often favored as their shorter half-life (i.e., reversibility) is advantageous in the event of a bleeding complication.

Preoperative Chemoprophylaxis

Preoperative chemoprophylaxis is generally employed for patients undergoing major pelvic

Fig. 1.1 Perioperative VTE prevention measures

Preoperative

Intraoperative

Postoperative

•Chemoprophylaxis

•Mechanical prophylaxis

•Early ambulation

•Chemoprophylaxis

•Mechanical prophylaxis

•Extended prophylaxis in select patients

1 Perioperative Venous Thromboembolism

surgery under general anesthesia extrapolating from data in the cancer population that this practice reduces perioperative VTE without increasing bleeding risk [26]. The American Society of Clinical Oncology (ASCO) Guidelines recommend chemoprophylaxis prior to major oncologic surgery with subcutaneous unfractionated heparin or enoxaparin unless contraindicated due to active bleeding, high risk of bleeding, or other contraindications [27]. Most enhanced recovery after surgery (ERAS) guidelines recommend preoperative mechanical and chemoprophylaxis prior to induction of general anesthesia for major pelvic operations in the absence of contraindications [9, 28].

Timing ofPostoperative Chemoprophylaxis

In the absence of postoperative bleeding concerns, chemoprophylaxis should be readministered within 24h of surgery. In patients who receive regional anesthesia with an epidural, consideration must be given to the timing of the most recent dose of chemoprophylaxis prior to epidural removal; a strategy of dosing in the evening so the epidural catheter may be removed the following morning may be helpful.

Mechanical Prophylaxis

Mechanical prophylaxis with compression stockings or SCDs can be employed to prevent perioperative VTE.Mechanical prophylaxis with SCDs is initiated prior to the induction of general anesthesia in the operating room. The CHEST Guidelines support the use of mechanical prophylaxis postoperatively for patients who have undergone inpatient pelvic surgery with intermittent pneumatic compression (e.g., SCDs) preferred over compression stockings [1]. Patients at moderate to high risk of VTE (most patients undergoing inpatient pelvic surgery) should receive both mechanical and chemoprophylaxis, but in patients at high risk for bleeding, mechanical prophylaxis alone is recommended over no prophylaxis [1]. In the cancer population, ASCO

Guidelines also recommend mechanical prophylaxis as an adjunct to chemoprophylaxis and do not endorse mechanical prophylaxis as monotherapy unless chemoprophylaxis is contraindicated [27].

Early Mobilization

Early mobilization after surgery is an effective means of decreasing VTE events and is now supported by guidelines and emphasized in most ERAS pathways, regardless of the indication for surgery [1, 24]. Although early ambulation decreases VTE risk during hospital admission following surgery, the use of mechanical prophylaxis with SCDs and chemoprophylaxis is still recommended in patients at moderate to high risk of postoperative VTE.

Extended Postoperative Chemoprophylaxis

Extended chemoprophylaxis in high-risk populations has been evaluated in both randomized controlled trials and observational studies and has been found to be safe and effective [7, 29–31]. A systematic review and meta-analysis conrmed these ndings [25]. Multiple guidelines support the use of extended chemoprophylaxis in the oncology population including the American College of Chest Physicians (ACCP), the ASCO, and the National Comprehensive Cancer Network (NCCN) [1, 27, 32]. The ASCO Guidelines recommend extended chemoprophylaxis following major oncologic surgery for a minimum of 7days and up to 4weeks in high-risk patients including those with restricted mobility, obesity, history of VTE, and others [27, 33].

Given the elevated risk of postoperative VTE in the IBD population relative to the oncology population, extended chemoprophylaxis is also recommended following major abdominal or pelvic surgery for IBD [34]. A systematic review of extended chemoprophylaxis in patients with IBD undergoing major surgery found that no data exist at present to guide extended chemoprophylaxis recommendations [14]. Within the identi-

K. A. Ban et al.

ed studies, VTE events occurred within varying timeframes up to 30 days from surgery [14]. Based on these ndings and the demonstrated safety of extended VTE chemoprophylaxis in the oncology population, extended chemoprophylaxis is also recommended for patients with IBD undergoing major pelvic surgery. The American Society of Colon & Rectal Surgeons has also recently updated their Venous Thromboembolism Clinical Practice Guidelines to include strong consideration of extended prophylaxis for colorectal cancer patients and consideration for IBD patients [33]. The main barriers to postdischarge chemoprophylaxis are adherence and patient cost. Orthopedic literature suggests oral agents were not associated with increased adherence, and cost was recently shown to be a signicant barrier for most colorectal surgery patients [35, 36].

Prophylactic IVC Filters

IVC lters are not recommended for prophylaxis prior to or following surgery in the general surgical population. Even among patients undergoing major oncologic surgery with contraindications to chemoprophylaxis, the ASCO Guidelines do not recommend prophylactic placement of IVC lters, noting an absence of randomized trials evaluating this practice and data on the potential long-term harm of IVC lters [27].

Diagnosis

Clinical Assessment andPhysicalExam

Clinical symptoms of DVT or PE can prompt further workup to conrm a VTE event. The assessment should begin with a history and physical exam to elicit risk factors for VTE and to evaluate for physical exam ndings. Extremity swelling with associated tenderness is consistent with DVT, while acute dyspnea, chest pain, hemoptysis, tachycardia, and increased oxygen require-

ments are signs concerning for PE. There are often additional diagnoses in the differential for symptoms like lower extremity swelling or dyspnea, so an initial workup should be broad. Of note, portomesenteric vein thrombosis is often detected incidentally during routine crosssectional imaging for postoperative ileus or highileostomy output [37].

Labs andTesting

Useful laboratory testing in the assessment of a possible VTE event includes D-dimer to assess for DVT and/or PE and an arterial blood gas (ABG) and electrocardiogram (ECG) for PE. Because additional diagnoses are initially included in the differential, additional testing is typically warranted. A complete blood count (CBC) and basic metabolic panel (BMP) may be included, and depending on symptoms, a chest X-ray, B-type natriuretic peptide (BNP), or troponin may also be appropriate.

D-dimer is a sensitive marker for VTE in the nonsurgical population but can be elevated in the inammatory state that follows major pelvic surgery. D-dimer levels greater than 500 mg/mL suggest presence of a PE; however, D-dimer levels normally increase with age. To avoid falsepositive results, an age-adjusted D-dimer threshold should be employed, calculated as the patient’s age multiplied by 10ng/mL for patients over 50 years [38]. A normal age-adjusted D-dimer can help avoid unnecessary imaging and rule out PE when the Pulmonary Embolism RuleOut Criteria pretest probability is low [38]. An elevated D-dimer should prompt additional evaluation with imaging to conrm the diagnosis.

ABG and ECG ndings are not sensitive but can increase or decrease index of suspicion for a clinically signicant PE.An ABG may demonstrate hypoxemia and hypocapnia (respiratory alkalosis), and an ECG may demonstrate signs of right-heart strain including a new right bundle branch block, rightward shift of the QRS axis, ST segment elevation in V1, atrial premature contractions, sinus tachycardia, atrial brillation/utter, or T wave inversions in leads V1–V4 [39].

1 Perioperative Venous Thromboembolism

In the evaluation of extremity swelling, a CBC, BNP, and assessment of volume status can help evaluate for cellulitis, heart failure exacerbation, and volume overload resulting in bilateral peripheral edema. In the evaluation of PE, a CXR, ECG, and troponin can evaluate for other pathology such as pneumonia, pneumothorax, and acute coronary syndrome.

Imaging

The diagnosis of a VTE event is conrmed with imaging. Compression ultrasonography is employed to conrm the presence of a DVT but may be limited in the morbidly obese, and venous-phase computed tomography (CT) of the pelvic vessels may show large groin clots. Computed tomography pulmonary angiography (CT-PE) is considered the gold-standard for diagnosis of acute PE.In patients with a contraindication to the contrast medium employed in CT-PE (allergy to contrast, acute or chronic renal failure), ventilation/perfusion (V/Q) scintigraphy may be considered. Alternatively, compression ultrasonography of the lower extremities can be obtained, as a proximal DVT in a patient with suspected PE is highly predictive and justies treatment. Importantly, though, a negative lower extremity ultrasound does not rule out PE.

Treatment

Therapeutic Anticoagulation

In patients without a contraindication, therapeutic anticoagulation is the preferred management of acute VTE [1, 27]. Therapeutic anticoagulation promotes clot resorption while preventing clot extension, hemodynamic collapse, DVT progression to PE, recurrent VTE, and mortality in the acute phase [38]. These benets must be weighed against the risk of bleeding, particularly in the postoperative setting. A postoperative VTE is considered “provoked,” with the risk of recur-

rence after treatment being low at <1% after 1-year and 3% after 5-years [40]. Anticoagulation is recommended for 3months because randomized trials have demonstrated that the long-term bleeding risk outweighs the risk of recurrent VTE beyond this timeframe, apart from patients with cancer in whom the annualized risk of VTE is much higher at 15% [27, 38].

Medication Options

Initial therapeutic options include unfractionated heparin as a continuous infusion with dosing guided by activated partial thromboplastin time (aPTT) assessment and therapeutic weight-based subcutaneous enoxaparin, which are appealing as they can be quickly held with a relatively short half-life in the case of bleeding. If the bleeding risk is low, oral anticoagulants are recommended due to ease of administration. Direct oral anticoagulants (DOACs), including direct thrombin inhibitors like dabigatran and factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban, have been evaluated and are recommended by multiple guidelines for the treatment of acute DVT and PE [40–42]. The DOAC agents are favored due to their rapid onset of action and predictable pharmacokinetics, which do not require ongoing laboratory assessment to titrate [38]. Vitamin K antagonists like warfarin remain preferred for patients with severe renal impairment [38]. A summary of recommended therapeutic agents is provided in Table1.1 along with populations in whom a particular agent might be preferred.

In the oncology population, the ASCO Guidelines support initial therapeutic anticoagulation with agents including unfractionated heparin, enoxaparin, fondaparinux, and rivaroxaban [27]. The NCCN Guidelines endorse monotherapy with unfractionated heparin, enoxaparin, dalteparin, and fondaparinux at doses listed in Table 1.2 [43]. Guidelines endorse additional agents including warfarin or edoxaban with a bridge like enoxaparin or dalteparin until the patient reaches therapeutic drug levels [43].

Table 1.1 Summary of therapeutic anticoagulation medication options per studies considered in CHEST Guidelines [40]

Medication Dose Preferred populations Unfractionated heparin IV 80units/kg or 5000units loading dose then

18units/kg/hr, target APTT of 2–2.5 x control, then SC 250units/kg q 12hrs

Enoxaparin 1–1.5mg/kg SC q 12hrs Malignancy

Liver disease and coagulopathy

Pregnancy Dabigatran 150mg PO BID Rivaroxaban 15–20mg PO BID Once daily dosing Apixaban 2.5mg PO BID or 5mg daily History of GI bleed Edoxaban 60mg PO daily Once daily dosing Warfarin Dose varies PO daily

Target INR 2.0–3.5

Once daily dosing

Renal disease

History of GI bleed

Poor compliance

K. A. Ban et al.

Table 1.2 Summary of therapeutic anticoagulation medication options per NCCN guidelines [43]

Medication Dose Unfractionated

heparin

Enoxaparin 1mg/kg SC q 12hrs Dalteparin 200units/kg SC daily for 30days,

Fondaparinux 5mg [<50kg]; 7.5mg [50–100kg];

IV 80units/kg load then 18units/kg/ hr, target APTT of 2–2.5 x control, then SC 250units/kg q 12hrs

then 150units/kg once daily for 2–6months

10mg [>100kg] SC daily

Thrombolysis andSuction Thrombectomy

Thrombolysis should be considered in the setting of a DVT where the extremity is at risk or in patients with a PE and hemodynamic instability. Catheter-directed thrombolysis can be considered for DVT, and systemic thrombolysis or suction thrombectomy can be considered for hemodynamically unstable PE [38]. In patients with large central clots who are high risk of bleeding preoperatively, suction thrombectomy may be considered [44]. Many hospitals have implemented PE response teams to facilitate timely interventional treatment for unstable patients. Thrombolysis carries a risk of bleeding, which is even more signicant in the setting of recent major pelvic surgery. The risks of inter-

ventional procedures must therefore be weighed against the risk of bleeding in the immediate postsurgical period. Patients in whom the bleeding risk is felt to be prohibitive should be evaluated for IVC lter placement.

IVC Filter Placement

IVC lter placement can be considered for patients with acute proximal DVT or PE who are not candidates for systemic anticoagulation or thrombolysis [38]. The use of an IVC lter for 3months in combination with therapeutic anticoagulation for patients with severe acute PE was recently evaluated in a randomized trial with no reduction in recurrent PE or death at 3- and 6-month follow- up [45]. In the cancer population, the ASCO Guidelines recommend against the insertion of IVC lters as prophylaxis in patients with chronic thrombosis (VTE diagnosis more than 4weeks prior) but support IVC lter placement consideration in patients with acute VTE (diagnosis within the last 4 weeks) with absolute contraindication to anticoagulant therapy if the thrombus burden is considered lifethreatening [27]. There is increased awareness about short- and long- term risks associated with the presence of an IVC lter. When no longer necessary, IVC lters should be removed. Some patients are candidates for therapeutic anticoagu-

1 Perioperative Venous Thromboembolism

lation further out from surgery, at which point surveillance imaging may demonstrate resolution of the thrombus. In these cases, IVC lters can and should be removed to prevent complications like lter migration, fracture, perforation, lter thrombus, and caval and/or iliac thrombosis.

Duration ofAnticoagulation

The recommended duration of anticoagulation following a provoked (postsurgical) VTE is 3months [38, 40], except in the cancer population where treatment should be continued until the cancer has been treated or at the discretion of the patient’s medical oncologist.

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jama.2015.3780.

Modern-Enhanced Recovery After Surgery (ERAS) forMajor Pelvic Surgery

LeileiXia andSiamakDaneshmand

In 1997, Dr. Henrik Kehlet from Denmark asked “why a technically successful operation, whether a colonic resection, hip replacement, or cardiac operation, should result in an unsuccessful outcome” [1]. He then described the multifactorial surgical stress response that can potentially be addressed with interventions. The goal of reducing the stress response from surgery and shortening the time required for full recovery to improve patient outcomes was the foundation of the modern Enhanced Recovery After Surgery (ERAS).

ERAS is a patient-centered, multidisciplinary, and evidence-based approach to surgical care. The original ERAS pathway was developed from colorectal surgery and the rst ERAS Study Group evidence-based consensus protocol was published in 2005 for those undergoing colorectal surgery [2]. After that, these multidisciplinary efforts to improve perioperative care across a wide spectrum of patients have been implemented within many surgical disciplines, including urology [3]. A growing body of evidence indicates that structured application of evidencebased principles and standardization of perioperative care signicantly improve clinical outcomes [3–7]. In 2010, the ERAS® Society was ofcially registered as a nonprot medical society based in

L. Xia · S. Daneshmand (*) Department of Urology, USC/Norris Comprehensive Cancer Center, Los Angeles, CA, USA e-mail: daneshma@med.usc.edu

Stockholm, Sweden (https://erassociety.org/). There are more than 30 guidelines published by the ERAS® Society and collaborators (https://

erassociety.org/guidelines/). In 2013, the ERAS

Society published guidelines for perioperative care after radical cystectomy (RC) [8]. In 2016, the ERAS® Society—Urology chapter was formed at the world congress in Lisbon.

RC with pelvic lymph node dissection (PLND) and urinary diversion (UD) is among the most complex urologic operations associated with considerable morbidity and prolonged inpatient stay [9–11]. Hospital stay after RC/PLND/UD is still among the minimally changed in the past decade, and the length of stays (LOS) remains in the 6–7days range in the United States and 10–17 days range in Europe [5]. RC/PLND/UD has been the target for ERAS pathways because of the complexity of care and the incidence of perioperative complications. A meta-analysis from 2016 included 13 studies (801 ERAS patients versus 692 controls) that showed complication rates favored the ERAS group (39.6% versus

51.5%) in patients undergoing RC [5]. It also showed reduced LOS and faster return of bowel function. Multiple other meta-analyses with updated studies conrmed ERAS for radical cystectomy can achieve better perioperative outcomes [4, 12, 13]. This chapter will be mainly using RC/PLND/UD as an example to further discuss ERAS protocols and we believe

https://doi.org/10.1007/978-3-031-66772-5_2

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