A Standardized Pathway For The Clinical Application Of Breast Biopsy Needles

https://www.mayoclinic.org/tests-procedures/breast-biopsy/about/pac-20384812

The clinical application of breast biopsy needles is an interventional technique highly dependent on the operator's experience. Standardized operating procedures not only improve diagnostic accuracy but also effectively reduce the risk of complications. This article, based on the *Chinese Guidelines for the Diagnosis and Treatment of Breast Diseases (2023 Edition)* and international authoritative consensus, systematically outlines the standardized operating procedures from preoperative preparation to postoperative follow-up, and focuses on analyzing risk control strategies.

I. Preoperative Assessment and Preparation: Laying the Foundation for Safe Operation

1. Control of Indications and Contraindications

Strict adherence to indications is a prerequisite for safe operation:

- Absolute Indications: Lesions classified as BI-RADS 4 or higher; clinically palpable and imaging-confirmed masses; newly developed or progressively enlarging microcalcifications.

- Relative Indications: BI-RADS 3 lesions but with significant patient anxiety; screening biopsies in high-risk individuals (BRCA mutation carriers).

- Contraindications: Severe coagulation disorders (INR > 1.5, platelet count < 50 × 10⁹/L); acute infection at the puncture site; pregnancy (especially early pregnancy); patient inability to cooperate (e.g., severe mental illness).

2. Precise Imaging Localization

Select the appropriate imaging guidance method based on the characteristics of the lesion:

- Ultrasound examination: Suitable for most detectable lesions, with advantages including real-time imaging and no radiation. The distance from the deepest point of the lesion to the body surface, as well as the anatomical relationship between the lesion and the nipple and pectoralis major muscle, needs to be marked preoperatively.

- Stereotactic biopsy: For microcalcifications visible only on X-ray, the CC and MLO coordinates of the lesion need to be calculated to determine the needle insertion angle (usually 0°, 15°, and 30° are three standard angles).

- MRI guidance: Used for multifocal lesions or dense breast tissue. A dedicated open coil is required, and preoperative scanning localization sequences (including T1WI, T2WI, and contrast-enhanced scans) are necessary.

3. Patient Communication and Informed Consent

Patients must be fully informed of:

- The purpose, necessity, and alternative procedures (e.g., surgical excision biopsy).

- Potential risks: bleeding (incidence 3%-8%), infection (0.1%-0.5%), pneumothorax (0.2%-0.8%), needle tract implantation (<0.01%).

- Post-operative precautions: apply pressure bandage for 24 hours, avoid strenuous exercise for 3 days, and observe the puncture site for bleeding or swelling.

When signing the informed consent form, special attention should be paid to providing additional information to high-risk groups, such as those taking anticoagulants (who must discontinue medication for at least 7 days) and women during menstruation (avoid procedures during menstruation).

II. Standardized Operating Procedures: From Puncture to Specimen Processing

1. Positioning and Anesthesia

- Positioning: Supine, lateral, or prone positions (specifically for stereotactic biopsy) are chosen based on the lesion location. Patient comfort and a stable lesion position must be ensured, avoiding respiratory interference.

- Anesthesia Administration: Local infiltration anesthesia with 1% lidocaine is used, with injection layers including the epidermis, subcutaneous tissue, and glands surrounding the lesion. The dosage of anesthetic should be controlled within 10ml to avoid tissue edema affecting lesion palpation or ultrasound imaging. For patients sensitive to pain, a small amount of sodium bicarbonate (1:10 ratio) can be added to reduce injection pain.

2. Key Techniques for Puncture Procedure

- Needle Path Planning: Follow the principle of "shortest path, least damage," avoiding blood vessels, nerves, and mammary ducts. Under ultrasound guidance, the needle tip must be kept parallel to the sound beam to ensure full visualization; stereotactic biopsies require verification of positioning accuracy using a test needle.

- Number of Punctures: Generally, solid lesions require 3-5 punctures, while microcalcifications require 4-6 punctures. When sampling multiple times along the same needle path, the needle tip should be rotated (45°-90°) each time to ensure sample representativeness.

- Specimen Acquisition Techniques: During vacuum-assisted biopsy, wait for the negative pressure to stabilize before firing and cutting; during core needle biopsy, hold the needle in place for 3 seconds after firing to avoid tissue retraction.

3. Specimen Processing Standards

- Specimen Labeling: Immediately place the specimen into the corresponding numbered formalin vial and label it with the patient's name, lesion location, and number of punctures.

- Specimen Imaging Verification: For microcalcification biopsies, take X-ray images of the specimen to confirm the presence of calcified tissue (positive predictive value >90%).

- Rapid Pathological Communication: For suspected malignant tumor cases, promptly contact the pathology department for rapid frozen section examination to provide a basis for subsequent surgical planning.

III. Complication Prevention and Management: From Prevention to Treatment

1. Hemorrhagic Complications

- Preventive Measures: Discontinue anticoagulants preoperatively; avoid puncture during the menstrual cycle; immediately apply pressure dressing (20-30 mmHg) and ice for 30 minutes postoperatively.

- Treatment: Small hematomas (<3cm) can be absorbed spontaneously without special treatment; large hematomas (≥3cm) require aspiration or incision and drainage, and hemostatic drugs (such as tranexamic acid) may be used if necessary.

2. Infectious Complications

- Prevention: Strict aseptic technique; disinfection of the puncture site ≥15cm; disposable needles must not be reused; diabetic patients need to control blood sugar (fasting blood glucose <8mmol/L).

- Treatment: For local redness, swelling, heat, and pain, administer oral antibiotics (such as cefuroxime axetil) for 3-5 days; if an abscess forms, incision and drainage are necessary, followed by bacterial culture and drug sensitivity testing.

3. Special Complications

- Pneumothorax: Commonly seen after puncture of deep medial lesions; chest X-ray is required immediately postoperatively. Small pneumothorax (lung compression <20%) can be conservatively observed; large pneumothorax requires closed chest drainage.

- Needle tract implantation: Extremely rare. Preventive measures include using coaxial puncture techniques and postoperative electrocoagulation of the needle tract. If it occurs, the excision area must be expanded (including the entire needle tract).

IV. Postoperative Management and Follow-up: Closed-Loop Quality Control

1. Immediate Observation

Postoperative observation in the recovery room for 30 minutes is required to monitor vital signs and check for active bleeding at the puncture site. A "Postoperative Instructions Card" should be issued, specifying the follow-up appointment time (usually 3-5 days after surgery to remove bandages, and 7 days to obtain the pathology report).

2. Interpretation and Communication of Pathology Results

- Benign lesions: Such as fibroadenoma and breast hyperplasia, patients should be informed to have regular follow-up examinations (ultrasound follow-up every 6-12 months).

- Atypical hyperplasia: Including ductal epithelial dysplasia (ADH) and lobular dysplasia (ALH), surgical resection or close follow-up (every 3-6 months) should be recommended.

- Malignant lesions: Immediately initiate a multidisciplinary team (MDT) consultation to develop a comprehensive treatment plan including surgery, chemotherapy, and radiotherapy. 3. Quality Improvement Mechanism

Establish a breast biopsy needle operation database, recording:

- Success rate (target ≥98%)

- Specimen qualification rate (target ≥95%)

- Complication rate (target: bleeding <5%, infection <0.5%)

- Diagnostic accuracy (compared with postoperative pathology, target ≥95%)

Conduct data analysis quarterly and provide specialized training on weak areas, such as puncture path optimization and complication management drills.

V. Key Points for Special Populations

1. Pregnant Patients

- Ultrasound guidance is preferred; avoid X-ray localization.

- In mid-to-late pregnancy, the left lateral decubitus position can be adopted to avoid supine hypotensive syndrome.

- Lidocaine (FDA Pregnancy Category B) should be used as the anesthetic; epinephrine is contraindicated.

2. Elderly Patients

- Assess cardiopulmonary function preoperatively and control blood pressure (<160/100 mmHg) and blood glucose (fasting <10 mmol/L). - Perform the puncture gently, avoiding repeated needle insertion and withdrawal to minimize tissue damage.

- Extend the pressure bandage application time to 48 hours post-procedure to prevent infection.

3. Patients with Coagulation Disorders

- If platelet count is <80×10⁹/L, administer a pre-operative platelet transfusion to >50×10⁹/L.

- If INR >1.5, administer 10mg of vitamin K₁ intravenously until INR <1.5 before proceeding with the procedure.

- Administer hemostatic agents (such as ethamsylate) post-procedure to prevent bleeding.

The clinical application of breast biopsy needles is a "millimeter-level" art of precision; every step affects diagnostic accuracy and patient safety. Only by strictly adhering to standardized procedures, strengthening risk control awareness, and establishing a continuous improvement mechanism can the advantages of this minimally invasive technique be maximized, providing safe and efficient diagnostic and treatment services for patients with breast diseases. In the future, with the popularization of AI-assisted puncture systems, the operating procedures will be further standardized, and the risk of complications will be reduced, promoting breast interventional diagnosis and treatment to a higher level of precision and safety.