An interventional radiologist, a perfusionist, and an anesthesiologist walk into a nonoperating room clinical suite and successfully perform a novel procedure for metastatic uveal melanoma, a rare, often-untreatable disease. It’s not a joke or even science fiction, but a reality at UCLA Health, where they are providing the Hepzato Kit™ procedure in an interventional radiology suite to deliver high doses of chemotherapy directly to the liver without exposing the rest of the body to the drugs. This targeted approach means fewer side effects, making the treatment safer and more effective for patients with metastatic uveal melanoma who have liver metastases that cannot be surgically removed.
“It’s an example of what can be done in a less-invasive setting and still make a big difference in patient care,” says Dane Saksa, MD, MBA, director of non-operating room anesthesia at UCLA Health. “Up until five to 10 years ago, interventional radiologists were doing most of their procedures without anesthesiologists, because they were more straightforward minimally invasive procedures, but that’s all changing. It’s a new environment for anesthesiologists to be in, and we’re still figuring out how to work together. It’s requiring a lot of adaptation on both sides, and we’re most successful when we tackle these things as a team.”
A hidden disease
Uveal melanoma, sometimes called ocular melanoma, is a type of cancer that affects the uvea, the middle layer of the eye that contains blood vessels, pigment cells (melanocytes), and provides nutrients and oxygen to the retina. It is a rare form of melanoma derived from the melanocytes in the uvea, accounting for only about 5% of all cases of melanoma in the United States. Only about 1,700 people are diagnosed with this type of cancer each year (asamonitor.pub/3ZW4w8s). Up to 50% of patients with uveal melanoma will eventually experience the development of metastatic disease, most often to the liver (~90% of cases). The prognosis of metastatic uveal melanoma patients with hepatic metastases is dismal, with a median overall survival of approximately one year (Ann Surg Oncol 2024;31:5340-51).
The U.S. Food and Drug Administration (FDA) approved use of the Hepzato Kit procedure in August 2023 to treat metastatic uveal melanoma. Doctors at the UCLA Stein Eye Institute and UCLA Jonsson Comprehensive Cancer Center, who were already treating patients with uveal melanoma, were quick to sign up and began using the procedure in early 2024. The procedure requires a high level of clinical skill and extensive collaboration across multiple departments. The team at UCLA includes interventional radiologist Siddharth Padia, MD, cardiac perfusionist, Kim De La Cruz, CCP, and anesthesiologist Dr. Saksa.
The minimally invasive procedure starts with an infusion of chemotherapy directly into the hepatic artery. Then the blood is drained from the body after it leaves the liver and passes through various special filtration systems that filter out all the chemotherapy drugs and then returns the blood back to the patient. The entire process typically takes about three hours, with patients often discharged the following day. Patients can receive the therapy up to six times.
“The interventional radiologist leads and performs the vascular intervention procedure, the perfusionist monitors and controls the extracorporeal pump and veno-venous bypass circuit, and the anesthesiologist manages the anesthetic and hemodynamic changes associated with the procedure,” says Dr. Saksa. “We’ve only been doing this procedure for about six months, and the communication among team members is exceptional because we’ve built the team from the ground up. We trained together and traveled to observe the clinicians who participated in the research trial for the Hepzato Kit, and it’s made us a tightknit unit. It’s the same level of teamwork I would expect to see during open-heart surgery, where everyone is in sync.”
Anesthesiologist as juggler
“When we start to filter the patient’s blood through the circuit, the patient is profoundly unstable from a blood pressure perspective. I am on my feet actively managing that throughout the procedure,” says Dr. Saksa, who is also an assistant clinical professor, UCLA Department of Anesthesiology and Perioperative Medicine. “It’s a similar situation to a patient undergoing cardiopulmonary bypass or a liver transplant, but we’re doing it in the radiology suite. We’re successful because we prepared, planned, and trained, and got buy-in from the hospital and our nurses. We are a team with the same goal, and the anesthesia is anything but simple. The anesthesiologist’s role is just as critical as the proceduralist’s role. The proceduralist with whom I work has learned this over the course of our first dozen cases, and he respects that.”
The patients have done well, says Dr. Saksa. “We have seen objective tumor response, if not a complete reversal. We’ve completed about two dozen cases, so we don’t have enough patients to provide statistics, but some of the early imaging studies are encouraging. More importantly, I’m starting to see repeat patients, which is a positive sign because that means the treatment is working. Part of that is because I thoroughly screen all of the patients in a preop clinic before their procedure. It’s often over Zoom because many of them are coming from far away. I ask a lot of questions to make sure the patient doesn’t have heart disease, a history of strokes, or any bleeding issues in the brain, and that they’re not on any blood thinners. We want patients who are healthy, without any other major comorbidities.”
“Unfortunately, it’s a disease that strikes younger people, so our average patient is in their 50s, but it makes patient selection a little more straightforward than if they were 85,” says Dr. Saksa.
Because the procedure is highly specialized and requires advanced training, it is only available at select medical centers that complete a risk evaluation and mitigation strategy (REMS) program administered by Delcath, manufacturer of the Hepzato Kit. The FDA has determined that a REMS is necessary to ensure that the benefits of the procedure outweigh the risks of severe periprocedural complications, including hemorrhage, hepatocellular injury, and thromboembolic events associated with its use. Health care settings must be certified to use the procedure (asamonitor.pub/3BAMBtX).
“It takes a commitment from leadership and clinicians to bring the procedure to your facility,” says Dr. Saksa. “UCLA was on board as soon as the FDA approved the treatment. Then we worked with Delcath to get training, which requires observing, shadowing, and proctoring. We visited the facility where some of the research trials had been conducted and observed several procedures. Then, they observed us doing procedures. Now that I’ve done 10 procedures, I can train, proctor, and mentor others.”
He enjoys sharing his experience with other clinicians. “I get these wide-eyed anesthesiologists from other hospitals who are excited about learning this new procedure. I tell them, ‘Be prepared, the blood pressure is going to go really low,’ but they’re never fully prepared for how low it can go. I’ve seen it go from a systolic BP of 180 to a systolic BP of 70 in one minute, even while I am aggressively supporting the pressure with vasopressors. And that’s just the normal anticipated physiologic response to this filtration system; but because we’re prepared, and we have the training we have as anesthesiologists, we’re the only people in the room that can keep the patient alive at that point.”
To ensure the procedure goes smoothly every time, he’s collected his learnings into a four-page, single-spaced clinical protocol. “I share it with other clinicians whom I train because it shows exactly how I set up my room, what medications to draw, what steps of the procedure to anticipate, and how to prepare for them. Now we do two of these in a day, and the patients usually go home the next morning with few or no side effects.”
The success of this procedure bodes well for attempting other complex procedures outside the OR. “As director of nonoperating room anesthesia, most of my issues are not clinical, they’re logistical and operational things. It’s about teamwork, safety, and communication,” says Dr. Saksa. “It’s nice to see a procedure like this where we started together as a multi-disciplinary team, and now we function like a well-oiled machine. It becomes an example of what all non-OR procedural interactions could be like.”
Anesthesia procedural steps when using the Hepzato Kit™
- Induction of general anesthesia and obtaining arterial and large-bore I.V. access by anesthesia
- Cannulation of right internal jugular vein, left internal jugular vein, right femoral vein, and left femoral artery by IR team
- Isolation of hepatic venous outflow via double balloon occlusion device
- Initiation of veno-venous bypass and blood filtration through proprietary Delcath filters, requiring aggressive hemodynamic management by anesthesiologist
- Chemotherapy infusion followed by washout period
- End of hepatic isolation, discontinuation of bypass, removal of cannulation sheaths, and emergence from anesthesia
- Recovery in PACU vs. ICU
