Metastatic cancer to the lung occurs when cancer cells break away from a primary tumor elsewhere in the body, enter the bloodstream or lymphatic system and spread to the lungs, forming pulmonary tumors or "nodules". In most cases, surgeons cannot remove multiple nodules (three or more) because conventional instrumentation causes extensive damage to the delicate lung tissue, leading to respiratory complications. As a result, patients are denied surgery and labeled "incurable."

Through the use of Starion's Thermal Ligating Shears, Mark M. Levinson, M.D., Chief of Cardiothoracic Surgery at Promise Regional Medical Center in Hutchinson, Kansas, has developed a breakthrough procedure - Removal of Multiple Metastases (ROMM) - whereby he can remove multiple nodules with minimal collateral tissue damage, giving patients new hope for a cure.

Mark M. Levinson, M.D., Chief of Cardiothoracic Surgery at Promise Regional Medical Center in Hutchinson, Kansas, is a visionary in his field. He is the founding member of the International Society of Minimally Invasive Cardiac Surgery, the founder and editor of The Heart Surgery Forum® and was selected as one of America's Top Surgeons by the Consumer's Research Council of America.

Levinson frequently evaluates patient cases where primary cancer sites have been completely controlled and every organ is free of tumor with the exception of the lungs. These lung "nodules" must be removed in order for the patient to be cancer free, but for patients with multiple nodules — three or more — the resection surgery is not an option since conventional instrumentation causes significant damage to the surrounding lung tissue, negating any potential benefit.

"These are patients who have no other sign of the disease because their primary cancer had been removed," said Levinson. "Some have undergone chemotherapy for years but the nodules in their lungs continue to grow."

Challenges and Limitations
Surgeons traditionally use a stapling device to harvest the nodules, surrounding each nodule with two rows of staple lines and passing a knife in between the lines to seal the lung tissue and remove the nodule. While the stapler effectively seals the tissue and prevents air leakage, it removes a large section of healthy lung tissue along with the nodule, limiting the number of nodules that can be removed from a patient.

"The stapler is a linear device, about eight centimeters long and you need about two to three of these staple lines to remove a single nodule," said Levinson. "As a result, you can only take out one or two nodules with a stapler before you've damaged a large portion of the lung," said Levinson.

According to Levinson, electrocautery is not an option since it does not effectively seal the tissue. "Standard cautery is based on radiofrequency so while it denatures the protein, the tissue separates causing massive air leakage – it literally pours out of the lung."

Seeking an alternative solution, Levinson tried the Harmonic Scalpel but the high heat and vibration generated by the device damaged the healthy lung tissue. "The Harmonic Scalpel passes electrical energy through the patient, causing lateral thermal spread and the vibration creates bubbles, which puffs the lung tissue up with gas," said Levinson.

A Safe and Effective Solution
An oncologist referred a man in his 30's with multiple lung nodules to Levinson to determine if surgery could be performed. The man's primary cancer site had been completely controlled and it was believed that he had two nodules in his lungs.

"I went into surgery and found multiple nodules," said Levinson. "Using the stapler, I removed two nodules but knew there was no way that I could cure the kid."

In a bold move, Levinson turned to Starion Instruments' Thermal Ligating Shears. Based on its safety and efficacy, Levinson believed that Starion's device might be beneficial to the case. He had been using it to harvest mammary arteries for Subxiphoid Multi-Arterial Bypass Surgery, an advanced minimally invasive technique that he developed as an alternative to traditional bypass surgery.

"As soon as I took out the Starion device I went through the tissue and thought wow!" said Levinson. "It was no brains, no headaches. We removed three or four nodules with only a tiny rim of surrounding lung tissue – about 1 1/2 to 2 millimeters from the outer edge of the mass."

Unlike conventional products employing monopolar, bipolar or ultrasonic energy, Starion's Thermal Ligating Shears feature the company's patented Tissue Welding technology, which uses direct heat and pressure to simultaneously seal and divide soft tissue and vessels. This reduces thermal spread, minimizing the risk of inadvertent collateral damage.

"With Starion, there is no thermal damage and very little, if any, air leakage. Some patients we've closed up after five or six nodules and there has been no air leakage at all."

Groundbreaking Results
Following that successful case, Levinson developed a revolutionary new procedure — Removal of Multiple Metastases (ROMM) — for treating patients with multiple nodules. Levinson makes an incision in the surface of the lung and then pushes the nodule from behind until it crowns. He then seals the tissue around the nodule with Starion's Thermal Ligating Shears. As a result, he has removed up to 17 nodules from a single lung and 23 nodules from a single patient with minimal tissue damage and no subsequent respiratory complications.

"It is a potential breakthrough operation and we couldn't do it without Starion," said Levinson. "We essentially sweep through the lung and remove all of the remaining disease from a patient's body – and that's not possible with any other instrument. We then follow up with six months of chemotherapy."

To date, Levinson has performed seven ROMM procedures using Starion's Thermal Ligating Shears. Because of the device's safety and precision, Levinson can now give hope to an entire population of patients who had been previously branded "incurable."

"Patients come to my office and they don't believe that I can do the procedure because they've been told by other surgeons that it was impossible," said Levinson. "With Starion, we can now cure people who otherwise would have been turned away to die."

For more information on the ROMM procedure, please visit Dr. Levinson's website.