Microsurgical Breast Reconstruction & VTE



Status:Completed
Conditions:Breast Cancer, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - 90
Updated:5/3/2018
Start Date:January 30, 2017
End Date:December 15, 2017

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Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism

Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis
(DVT) and continues to be a major patient safety issue after reconstructive plastic surgery.
Significant morbidity and mortality is associated with VTE events. This disease entity
represents the most common cause of preventable in-hospital death as evidenced by over
100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial,
with annual costs to the U.S. healthcare system in excess of $7 billion.

Cancer patients have been identified as a particularly vulnerable patient population. Of
these, breast cancer patients represent the largest group treated by plastic surgeons. An
increasing number of breast reconstructions are performed in the U.S. with a documented 35%
increase in the annual number of breast reconstructions since 2000. Over 106,000 breast
reconstructions were performed in 2015 alone.

Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is
associated with the highest risk for VTE. We believe that a key element rendering these
patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is
supported by the observation that VTE risk remains elevated for up to 12 weeks
postoperatively. We hypothesize that lower extremity deep venous system stasis is a
procedure-specific key contributing factor to postoperative VTE risk.

This study examines the duration of postoperative lower extremity venous stasis to identify
patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging
technology to examine the lower extremity deep venous system preoperatively, on postoperative
day 1, and on the day of discharge to determine if patients display radiographic evidence of
lower extremity venous stasis at the time of hospital discharge.

A better understanding of pathophysiologic mechanisms that contribute to the development of
VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE
prophylaxis, thus, favorably impacting clinical outcome in a large patient population.


Inclusion Criteria:

- see study population description

Exclusion Criteria:

- Superficial inferior epigastric artery flaps

- Donor-sites other than the abdomen

- Chronic obstructive pulmonary disease (COPD)

- Liver disease.
We found this trial at
1
site
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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from
Stanford, CA
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