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DESCRIPTIONPatients undergoing major orthopedic surgery are at increased risk for venous thromboembolism (VTE). Patients undergoing other types of surgery may also be at increased risk of VTE. Limb pneumatic compression devices are one option for thromboprophylaxis and are commonly used in the hospital setting. Outpatient use of pneumatic compression devices following hospitalization, with or without pharmacologic prophylaxis, has also been proposed.
Patients undergoing major surgery are at increased risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE), together known as venous thromboembolism (VTE). Patients who are having major orthopedic surgery (defined here as total hip arthroplasty [THA], total knee arthroplasty [TKA] and hip fracture surgery [HFS]) are at particularly high risk. Risk of DVT is increased due to venous stasis of the lower limbs as a consequence of immobility during and after surgery. In addition, direct venous wall damage associated with the surgical procedure itself may occur. DVTs are frequently asymptomatic and generally resolve when mobility is restored. However, some episodes of acute DVT can be associated with substantial morbidity and mortality. The most serious adverse consequence of an acute DVT is a PE which can be fatal; this occurs when the DVT detaches and migrates to the lungs. In addition, DVT may produce long-term vascular damage that leads to chronic venous insufficiency. Without thromboprophylaxis, the incidence of venographically detected DVT is approximately 42-57% after total hip replacement, and the risk of pulmonary embolism is approximately 1-28%. Other surgical patients may also be at increased risk of VTE during and after hospitalization. For example, it is estimated that rates of VTE without prophylaxis after gynecologic surgery is about 15-40%.
Thus, antithrombotic prophylaxis is recommended for patients undergoing major undergoing orthopedic surgery and other surgical patients at increased risk of VTE. For patients undergoing major orthopedic surgery, clinical practice guidelines published in 2012 by the American College of Chest Physicians (ACCP) recommend that one of several pharmacologic agents or mechanical prophylaxis be provided rather than no thromboprophylaxis. The guidelines further recommend the use of pharmacologic prophylaxis during hospitalization, whether or not patients are using a pneumatic compression device. The ACCP guidelines noted that compliance is a major issue with pneumatic compression devices used for thromboprophylaxis and recommend that, if this prophylactic option is selected, use should be limited to portable, battery-operated devices. Moreover, it is recommended that devices be used for 18 hours per day. A 2009 non-randomized study found that there was better compliance with a portable battery-operated pneumatic compression device compared to a non-mobile device when used by patients in the hospital following hip or knee replacement surgery.
The ACCP also issued guidelines on VTE prophylaxis in non-orthopedic surgery patients. For patients undergoing general or abdominal-pelvic surgery who have a risk of VTE of 3% or higher, the ACCP recommends prophylaxis with pharmacologic agents or intermittent pneumatic compression rather than no prophylaxis. For patients at low risk for VTE (about 1.5%), the guidelines suggest mechanical prophylaxis. Unlike the guidelines on major orthopedic surgery, which recommends a minimum of 10-14 days of VTE prophylaxis, the guideline on non-orthopedic surgery patients does not include a general timeframe for prophylaxis. They do, however, define “extended duration” pharmacologic prophylaxis as lasting 4 weeks; the latter is recommended only for patients at high risk for VTE, undergoing abdominal or pelvic surgery for cancer who are not otherwise at high risk for major bleeding complications.
National clinical guidelines have not specifically recommended use of pneumatic compression devices in the outpatient setting. However, especially with the availability of portable, battery-operated devices, there is interest in use of outpatient pneumatic compression devices for DVT following discharge from the hospital for major orthopedic and non-orthopedic surgery.
Multiple limb pneumatic compression devices, with indications including prevention of DVT, have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Portable battery-operated devices that have been cleared by the FDA include:
A related medical policy is Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers.
POLICYOutpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis after major orthopedic surgery may be considered medically necessary in patients with a contraindication to pharmacological agents i.e., at high-risk for bleeding.
Outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery may be considered medically necessary in patients who are at moderate or high risk of venous thromboembolism (see Policy Guidelines) with a contraindication to pharmacological agents i.e., at high-risk for bleeding.
Outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis after major orthopedic surgery is considered investigational in patients without a contraindication to pharmacological prophylaxis.
Outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery is considered investigational in patients who are at moderate or high risk of venous thromboembolism without a contraindication to pharmacological prophylaxis and in patients who are at low-risk of venous thromboembolism.
Outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis after all other surgeries is considered investigational.
Outpatient use of limb pneumatic compression devices for venous thromboembolism prophylaxis for periods longer than 30 days post-surgery is not medically necessary.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESFor purposes of this policy, “major orthopedic surgery” includes total hip arthroplasty, total knee arthroplasty, or hip fracture surgery.
Guidance on Determining High Risk for Bleeding
The ACCP guidelines on prevention of VTE in orthopedic surgery patients list the following general risk factors for bleeding:
The guidelines note, however, that “specific thresholds for using mechanical compression devices or no prophylaxis instead of anticoagulant thromboprophylaxis have not been established.”
A clinical guideline from the American Academy of Orthopaedic Surgeons (2011) states:
Guidance on Duration of Use
In patients with contraindications to pharmacologic prophylaxis who are undergoing major orthopedic surgery (THA, TKA or HFS), the ACCP guidelines are consistent with use of intermittent pneumatic compression devices for 10-14 days after surgery. The ACCP suggestion on extended prophylaxis (up to 35 days) was a weak recommendation that did not mention pneumatic compression devices as an option.
In the ACCP guideline on VTE prophylaxis in patients undergoing non-orthopedic surgery, the length of standard duration or “limited duration” prophylaxis was not defined. However, “extended duration” pharmacologic prophylaxis was defined as 4 weeks; this was recommended only for patients at high risk for VTE undergoing abdominal or pelvic surgery for cancer and not otherwise at high risk for major bleeding complications.
Guidance on Risk Level for Patients Undergoing Non-orthopedic Surgery
The ACCP guidelines on prevention of VTE in non-orthopedic surgery patients included the following discussion of risk levels:
“In patients undergoing general and abdominal-pelvic surgery, the risk of VTE varies depending on both patient-specific and procedure-specific factors. Examples of relatively low-risk procedures include laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, inguinal herniorrhaphy, and unilateral or bilateral mastectomy. Open abdominal and open-pelvic procedures are associated with a higher risk of VTE. VTE risk appears to be highest for patients undergoing abdominal or pelvic surgery for cancer. Patient-specific factors also determine the risk of VTE, as demonstrated in several relatively large studies of VTE in mixed surgical populations. Independent risk factors in these studies include age at least 60 years, prior VTE, and cancer; age >60 years, prior VTE, anesthesia at least 2 h, and bed rest at least 4 days; older age, male sex, longer length of hospital stay, and higher Charlson comorbidity score; and sepsis, pregnancy or postpartum state, central venous access, malignancy, prior VTE, and inpatient hospital stay more than 2 days. In another study, most of the moderate to strong independent risk factors for VTE were surgical complications, including urinary tract infection, acute renal insufficiency, postoperative transfusion, perioperative myocardial infarction, and pneumonia.“
The American College of Obstetricians and Gynecologists (ACOG) proposed the following risk classification for VTE in patients undergoing major gynecological surgery:
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/21/2013: Approved by Medical Policy Advisory Committee.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.28
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.