The ground-breaking NOTES™ approach through the mouth, facilitated by a computer-powered instrumentation platform, provides a revolutionary and less invasive way to perform traditional surgical procedures
Heralding the dawn of a new age in surgical technology, a team of Baystate Medical Center physicians announced today (July 12, 2007) they have performed the world’s first reported stapled NOTES™ cyst-gastrostomy to successfully treat and save the life of a seriously ill patient who had been hospitalized for months with a chronic infected pancreatic pseudocyst, without the need for an abdominal incision.
The emerging field of NOTES™ (Natural Orifice Translumenal Endoscopic Surgery) is a cutting-edge surgical and gastroenterological approach which involves passing flexible surgical tools and a camera through the patient’s natural orifices to eliminate incisions, resulting in less pain, infection, and quicker recoveries. In addition, many patients who are high risk candidates for surgery may be able to be treated with this new less invasive surgical approach.
Traditional methods of treatment including the use of stents to help drain the infected pancreatic pseudocyst plaguing 72-year-old Eugene LaFlam of Brattleboro, Vermont, had been unsuccessful in completely clearing the infection. Other medical complications did not make him a good candidate for an invasive surgical procedure. As a result, the surgical team decided to perform an innovative procedure on LaFlam at Baystate Medical Center on June 26, utilizing only the patient’s mouth enabled by a computer-powered surgical stapling system from Power Medical Interventions®, Inc. of Langhorne, PA, to reach the surgical site.
“Our team’s research of recent NOTES™ technological innovations over the past year, our subsequent experimentation with this new flexible stapler from PMI, and our desire to perform a procedure in the least invasive fashion possible on Mr. LaFlam due to his deteriorating condition, all contributed to our decision to perform this new innovative procedure on him,” said Dr. John Romanelli, FACS, director, Bariatric Surgery, Baystate Medical Center. Romanelli, a longtime pioneer in the field of minimally-invasive surgery, performed the surgery along with the assistance of Dr. David Desilets, Chief of Gastroenterology at Baystate Medical Center.
LaFlam has been hospitalized since February with a chronically infected pseudocyst of the pancreas, likely brought about by a gallstone. He was transferred to Baystate Medical Center from a Vermont hospital where a surgeon there was familiar with Romanelli’s surgical expertise. During his hospitalization, small stents or “drains” were placed through an endoscope, connecting the stomach to the infected pseudocyst for drainage of the pseudocyst’s contents. The large size of the pseudocyst and severity of the infection contributed to the stent’s ineffectiveness in long-term drainage and clearance of the life-threatening infection, which persisted despite the use of the stents and several highly-potent antibiotic regimes over months of treatment.
According to Romanelli, a surgical procedure with abdominal incisions typically would have been performed to create a large, stapled “link” between the pancreatic pseudocyst and stomach. However, in the case of Mr. LaFlam, the location of the pseudocyst made a traditional surgical approach difficult, yet ideal for approaching it from the esophagus. Another consideration was the patient’s weakened immune system and decreased ability to heal, which made even laparoscopic surgery risky, despite the small incisions used.
During the NOTES™ procedure, a computer powered surgical stapler from Power Medical Interventions® was passed through LaFlam’s mouth and into his stomach alongside a small endoscopic camera. Utilizing a remote control unit, the stapler was positioned and fired, resulting in a connection between the pseudocyst and the stomach, creating a large “pathway” through which the infected pancreatic pseudocyst fluid could drain harmlessly into the stomach in order to clear the infection.
LaFlam recovered quickly and had no pain or other complications. After being fed intravenously for several months prior to the procedure, he began eating clear liquids two days after the procedure. Other critical vital signs, including his white blood count (a sign of infection) dropped significantly for the first time in over a month, a sign that he was recovering quickly.
After re-examining LaFlam with an endoscope six days after the procedure, Desilets said he was thrilled with the results and happy to have good news for their patient.
“The anastomosis was wide open, and the pseudocyst was almost completely gone along with all the dead tissue and clot which had been previously observed. The use of the Power Medical Interventions® computer mediated flexible stapling technology to perform NOTES™ procedures like this will reduce the risk of surgery for many patients,” Desilets said.
(An anastomosis is the surgical union of two hollow organs, for example, blood vessels or part of the intestine, to ensure continuity of the passageway.)
Dr. Loring Flint, senior vice president, Medical Affairs, Baystate Medical Center, praised the medical staff’s embracing of new technology and innovative procedures such as NOTES™.
“I am proud of the entire surgical team at Baystate Medical Center who were involved in this pioneering surgery and commend Dr. Romanelli and Dr. Desilets for their collaborative and creative approach in the use of new technology which saved
Mr. LaFlam’s life,” Flint said.
“We are excited to join an elite group of very few hospitals in the world who have performed a NOTES™ procedure, and are delighted to have made this important contribution to the medical community in forwarding the current research and investigation behind this revolutionary technique to benefit future patients,” he added.
Romanelli further commented on the new technology used during the procedure.
“The Power Medical Interventions® stapler allowed us to maneuver through the esophagus and stomach, turn corners and create a large opening between the pancreas and the stomach with precisely-fired staples, all without making an incision in the patient’s abdomen. PMI’s platform is an essential surgical device for NOTES™, as older similar devices are too bulky and do not allow access through the body’s natural orifices,” he said.
Open surgery, which relies on the creation of an incision large enough in the patient to allow a direct view of the operating field and insertion of surgical instruments, was for years the most common form of surgery. However, over the past 30 years, surgery has undergone significant technological innovations. Advanced instrumentation has led to improved visualization, access, and diagnostic capability with the use of smaller incisions. Referred to as minimally invasive surgery, the technique has replaced many surgeries once performed only by large incisions.
“Now the evolution of NOTES™ is ushering in yet a new era to benefit patients by offering us an even less invasive approach to surgery involving a procedure performed through natural openings such as the mouth or anus instead of the abdominal ports used in minimally invasive surgery,” Romanelli said.
In addition, Romanelli said expanding technology and the resulting new procedures such as NOTES™ will have a significant impact on medicine in the 21st century as the medical community focuses less on specialty medicine and looks toward a more team-oriented, disease-focused approach.
“With NOTES™ we have already begun to see a blurring of distinctions between specialties as evidenced in the operating room at Baystate Medical Center where a surgeon and gastroenterologist, along with other members of the surgical team, were working side-by-side to treat Mr. LaFlam,” he added.
As for giving him “a new lease on life,” LaFlam said he couldn’t thank his doctors enough.
“Boy, do I feel great now, it’s the best thing that ever happened to me, because until the procedure, I was on a roller coaster ride,” LaFlam said.
“There are always risks when you go through an operation, but my wife and I didn’t care, we said ‘Go for it!”, he added about the new procedure which he hoped would return him to good health.
And his wife, Diane is feeling pretty good, too.
“We’re so thankful to Dr. Romanelli and Dr. Desilets for performing this new lifesaving procedure. It’s what saved my husband’s life, and will hopefully help more people,” she said.