Entrepreneur Back in Business After Protected PCI Procedure
Impella CP® helps to prevent a “heart attack waiting to happen”
Rogelio Landin was a man on the go, running full tilt, often working 21 hours a day seven days a week. Until, one day, he hit the wall.
Rogelio had spent years working on ways to make more resources, such as libraries, technologies and teacher development, available to economically disadvantaged school districts throughout the country. He was also chairman of Matrix Human Services, a Detroit-based organization that oversaw Head Start and other early childhood development programs. He was active in the community with many extracurricular activities. When weather permitted, he liked to ride his bike or walk.
But Rogelio also had health issues. Since 2006, he had gone through three transient ischemic attacks (TIA) – a temporary clot or blockage that cuts off blood flow to the brain and causes stroke-like symptoms but no permanent damage. Although TIAs are commonly labeled as “mini-strokes,” they can more accurately be described as a warning that the person is at risk for stroke. He also had diabetes, peripheral artery disease, high blood pressure and high cholesterol.
In 2012, Rogelio began to notice some pain, numbness and weakness in his legs, typically brought on by walking or other types of exercise. There were no other troublesome symptoms, such as labored breathing. Although he was not overly concerned, he knew his health history warranted a visit to his doctor.
“I was just going in for some leg work,” he said.
He was completely unprepared for what he would find out. Testing revealed that three of Rogelio’s coronary arteries were almost completely blocked – a complex and dangerous condition unrelated to his leg discomfort. “I was a heart attack waiting to happen,” he said.
“Since Rogelio had already been on the maximum medical therapy to improve his blood flow, more powerful drugs were not the answer”, said Theodore L. Schreiber, MD, an interventional cardiologist at Detroit Medical Center and president of the Cardiovascular Institute in Detroit.
One option was to unblock arteries through percutaneous coronary intervention (PCI), a procedure in which clogged or blocked arteries are reopened with the help of a balloon-tipped catheter that is threaded through the blood vessel to the site of a blockage. The balloon is inflated, pushing the blockage out of the way and then a tiny wire-mesh stent is placed to prop open the artery. But Rogelio’s doctors feared that, given his condition, any complication could be fatal. “A complication could have sent him into an irreversible cardiac arrest,” Dr. Schreiber said.
Another option was a triple heart bypass operation. This is a major open heart surgery in which the chest is cracked open, blood vessels are taken from another area of the body (typically the leg) and grafted onto the existing heart vessel before and after the blockage, thus bypassing the blockage. But again, Rogelio’s challenging health history and the potential complications put him at great risk.
“His heart was too weak to tolerate safe open heart surgery to fix all of the blockages,”
A New Device on the Way
As it turned out, the Detroit Medical Center was about to receive a new device that would make PCI an alternative to a triple bypass operation.
The device was a tiny heart pump called Impella CP, a small mechanical cardiovascular support system made by Boston-based Abiomed, Inc. that had just received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
“They pulled me aside and said they had this new device arriving early next week and that I was a prime candidate for it,” Rogelio said. Rogelio was told that the Impella CP, would allow him to safely have the non-invasive PCI procedure. Consisting of a tiny pump inside a catheter, the Impella CP has an electric motor that can pump up to 3.5 liters of blood per minute.*
The new intravenous device was inserted through the femoral artery of the groin to the heart’s main pumping chamber. There it could pump the blood out of Rogelio’s heart cavity (left ventricle) to the rest of his body.
By assisting the function of his heart, the hope was that Impella CP would allow Dr. Schreiber to perform a safe, complete revascularization while allowing his heart to rest and recover.
“I discussed it with my cardiologist, Dr. Narsingh Gupta, and going with the Impella CP made a lot of sense to me as a pragmatic person”.
Watching His Own Procedure
As Rogelio was the first patient to receive the Impella CP in the North America at Detroit Medical Center Heart Hospital, the gallery was full, eager to watch the procedure. Some of the observers had come all the way from Germany.
“There was a lot of interest in how this would go,” Rogelio said.
Rogelio remained awake – or, at least, more awake than asleep – so he could offer feedback as the procedure progressed. The doctors would ask him: Was he feeling pressure? Pain? All the while, he watched the procedure on the video monitor.
“It was kind of neat to be a part of history,” he said.
Rogelio watched as a guidewire with an uninflated balloon at its tip was maneuvered to the blockage and, once there, opened up to push away the plaque causing the blockage. The physicians then removed the balloon and threaded a tiny, expandable metal mesh tube called a drug-eluting stent to the site where it was expanded to prop open the artery. Drug-eluting stents are coated with a slow-releasing medication that helps prevent scar tissue from forming around the stent and potentially reblocking the artery.
This process was repeated for each blockage, leaving Rogelio’s major blood vessels repaired and wide open.
Then Dr. Schreiber began to wean Rogelio off of the Impella CP pump, carefully measuring the blood pressure and filling pressure of the heart as they did so. Once he was assured Rogelio’s heart was pumping well on its own, he removed the device and the 4.5 millimeter sheath and stitched up the small access incision.
Surgery on severe heart disease had come full circle at DMC during Rogelio’s lifetime. The first open heart surgery with open heart Cardiopulmonary bypass was performed at DMC in 1952, the year before Rogelio was born. Now, 60 years later, one of the first closed heart procedures was done there, too.
Rogelio Back on the Go
After the procedure, Rogelio was taken to the intensive care unit. It wasn’t long before he had taken out his smartphone to conduct business for his latest company, PerformancED.
“He was back on his feet the next day,” said Rogelio’s daughter, Rebecca Landin-Smith.
Two days after the procedure, he was discharged home.
A week after going to the doctor about his leg issues, he was chairing a board meeting for Matrix Human Services. A month later, he went to back to the cardiologist to have the work done on his legs – the problem that originally prompted him to visit his doctor.
“I’ve felt great since the procedure,” Rogelio said.
Rogelio is back to riding his bike, and can go as much as 20 miles at a time – “not bad for a 63-year-old,” he said. He walks and takes the stairs as much as he can. He continues to see his cardiologist, Dr. Gupta, every three months or so.
“I like to inject physical activity whenever I can,” he said.
Since the procedure, in addition to his work in education to help the disadvantaged, Rogelio has become a “heart recovery advocate.” Working with Abiomed and other Impella patients around the country, he tells his story so that others might benefit from his experience, including testifying before an FDA panel about heart devices like Impella CP. He also was a speaker at “goREDTALKS,” a showcase of speakers not unlike Ted Talks, at the Detroit Medical Center Heart Hospital in September 2016. “More patients, physicians and payers need to know about alternatives, such as using a device like Impella CP for pre-emptive or preventive purposes rather than just a means to survival”, he said.
Impella CP is now available to more patients: In December 2016 , the FDA gave approval to the Impella CP to provide treatment for patients with high-risk percutaneous intervention procedures. This approval expands the patient population that can be safely and effectively treated with Impella CP in the high-risk PCI setting.
“My message is – why have a heart attack if you don’t have to?”
Making heart repair safer for no-option patients recommended for a PCI procedure
- The world’s smallest heart pump
- Impella® is a heart pump intended for temporary (≤ 6 hours) use by patients with severe symptomatic CAD and diminished (but stable) heart function who are undergoing PCI but are not candidates for surgical coronary bypass treatment