1. (a) Splenoportography (needle injection of contrast media into the spleen).

   1. (1) All associated risks as listed under §602.2(b)(2) of this chapter (relating to Cardiovascular System Treatments and Procedures).
   2. (2) Injury to the spleen requiring blood transfusion and/or removal of the spleen.

2. (b) Chemoembolization.

   1. (1) All associated risks as listed under §602.2(b)(2) of this chapter.
   2. (2) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).
   3. (3) Injury to or failure of liver (or other organ in which tumor is located).
   4. (4) Risks of the chemotherapeutic agent(s) utilized.
   5. (5) Cholecystitis (inflammation of the gallbladder) (for liver or other upper GI embolizations).
   6. (6) Abscess (infected fluid collection) in the liver or other embolized organ requiring further intervention.
   7. (7) Biloma (collection of bile in or near the liver requiring drainage) (for liver embolizations).

3. (c) Radioembolization.

   1. (1) All associated risks as listed under §602.2(b)(2) of this chapter.
   2. (2) Tumor lysis syndrome (rapid death of tumor cells, releasing their contents which can be harmful).
   3. (3) Injury to or failure of liver (or other organ in which tumor is located).
   4. (4) Radiation complications: pneumonitis (inflammation of lung) which is potentially fatal; inflammation of stomach, intestines, gallbladder, pancreas; stomach or intestinal ulcer; scarring of liver.

4. (d) Thermal and other ablative techniques for treatment of tumors (for curative intent or palliation) including radiofrequency ablation, microwave ablation, cryoablation, and high intensity focused ultrasound (HIFU).

   1. (1) Injury to tumor-containing organ or adjacent organs/structures.
   2. (2) Injury to nearby nerves potentially resulting in temporary or chronic (continuing) pain and/or loss of use and/or feeling.
   3. (3) Failure to completely treat tumor.

5. (e) TIPS (Transjugular Intrahepatic Portosystemic Shunt) and its variants such as DIPS (Direct Intrahepatic Portocaval Shunt).

   1. (1) All associated risks as listed under §602.2(b)(2)-(4) of this chapter.
   2. (2) Hepatic encephalopathy (confusion/decreased ability to think).
   3. (3) Liver failure or injury.
   4. (4) Gallbladder injury.
   5. (5) Hemorrhage (severe bleeding).
   6. (6) Recurrent ascites (fluid building up in abdomen) and/or bleeding.
   7. (7) Kidney failure.
   8. (8) Heart failure.
   9. (9) Death.

6. (f) Myelography.

   1. (1) Chronic (continuing) pain.
   2. (2) Nerve injury with loss of use and/or feeling.
   3. (3) Transient (temporary) headache, nausea, and/or vomiting.
   4. (4) Numbness.
   5. (5) Seizure.

7. (g) Percutaneous abscess/fluid collection drainage (percutaneous abscess/seroma/lymphocele drainage and/or sclerosis (inclusive of percutaneous, transgluteal, transrectal and transvaginal routes)).

   1. (1) Sepsis (infection in the blood stream), possibly resulting in shock (severe decrease in blood pressure).
   2. (2) Injury to nearby organs.
   3. (3) Hemorrhage (severe bleeding).
   4. (4) Infection of collection which was not previously infected, or additional infection of abscess.

8. (h) Procedures utilizing prolonged fluoroscopy.

   1. (1) Skin injury (such as epilation (hair loss), burns, or ulcers).
   2. (2) Cataracts (for procedures in the region of the head).

Source Note:The provisions of this §602.14 adopted to be effective December 26, 2023, 48 TexReg 7985.