A new medical device, under testing now in Colorado Springs, stands to radically improve heart medicine.
The medical trial involves a device called a bioresorbable vascular scaffold, or Absorb, placed in the arteries leading to the heart.
The Absorb is a small mesh tube designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the blood vessel over time, much like dissolvable suture.
“In cardiology, no other study is this much of a game-changer,” said Memorial Hospital cardiologist Dr. Jonathan Sherman, principal investigator for the clinical trial currently underway. “Should this be positive, we’ve really developed a new technique that enables us to improve the lives of our patients both now and in the future.”
Memorial is enrolling patients now in the national clinical trial, aimed at treating blocked or narrowing arteries resulting from heart disease. Memorial is one of 140 hospitals chosen nationwide by healthcare company Abbott for the study.
“They want the top hospitals in the country, and for us, this is a huge honor,” Sherman said. “They’ve taken a big gamble.”
“Coronary artery disease is the leading cause of death for men and women in the United States,” said cardiologist Dr. Ronald Blonder, medical director of cardiac research at Memorial. “Symptoms such as chest pain and shortness of breath can occur when the demand for blood to the heart is more than its ability to supply it.
“Plaque buildup in the arteries can lead to blocked heart vessels and restrict blood flow, increasing the risk for heart attack and stroke,” Blonder said.
Each year, about 785,000 Americans experience a first heart attack. Another 470,000 who have already experienced one or more heart attacks will have another. Heart disease accounts for one of every six deaths in the U.S.
In current practice, cardiologists place metallic stents into the arteries leading to the heart. Metallic stents do not dissolve like the Absorb.
Twenty years ago, blocked arteries were opened by balloon angioplasty. This practice caused damage to the heart vessel, Sherman said. Twenty percent of those patients would subsequently suffer closure of the arteries.
“That’s why we built stents. It helped with the problem of acute closure,” Sherman said. “However, stents didn’t fully stop the process of scar tissue.”
Current technology “works very well, better than what we had 10 years ago,” he said.
About 10 years ago, Abbott started developing the Absorb. Now Abbott is the first company in the world to begin testing a device like this in U.S. patients.
The Absorb is another way to better improve provide heart care, Sherman said.
“It’s important to explore these new technologies,” Sherman said. “Everything we’re doing is iterative,” or built upon past successes to achieve a goal.
The Absorb has been approved in Europe but still needs approval from the U.S. Food & Drug Administration. Approval of this device for general use is pending the results of this trial.
The clinical trial dictates that some patients have the Absorb implanted and others have traditional metallic stents placed. Only the physician who places the device knows whether it is a metallic stent or an Absorb.
Nationally, 2,000 will be chosen for the trial. The trial will end 12 months after the last person is enrolled. Once the device is placed, the patient’s health will be monitored for five years.
So far, Memorial Hospital cardiologists have screened between 50 and 100 patients for the trial. Of those, three have met the requirements to be in the study and have had devices implanted.
“Our goal in the trial is to enroll 20,” he said. “We’re feverishly screening patients to find ones that meet the clinical criteria.”
To be accepted, patients must have proven blockage in one of their arteries. They also must not have been in a clinical trial in the past 12 months, must not have active cancer, not be taking blood thinner, and fulfill other requirements, Sherman said.
The patients “makes a conscious choice to have the procedure,” Sherman said. “We can make no promises about the efficacy of the device.
“We have no idea if this is better than current care.”
But the “promise” of this technology is good, Sherman added, because “it’s going to change the way we treat patients.”
Traditional metallic stents allow many patients to avoid open-heart surgery, Sherman said, “but the support structure is not needed long-term.
“We are making history by participating in this landmark study involving a flexible, dissolvable structure,” he said
Other physicians involved in the study include Dr. David Greenberg, Dr. Jim Glass, Dr. Joe Lee, Dr. Russell Linsky and Dr. Jorge Davalos. The trial is also enrolling patients at the University of Colorado Health in Denver and Poudre Valley Hospital in Fort Collins.