Nano pacemaker implanted in Long Island patient's heart
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Doctors have implanted a “nano” heart pacemaker in a Long Island patient, a miniature self-contained device that has no wires and is so small it was inserted directly into the heart without surgery.
Robert Johnson, 50, of Dix Hills received the device in the minimally invasive procedure on a recent Friday and was back to work the following Monday as foreman of a sheet metal company in Queens.
The pacemaker is one in an increasing number of gee-whiz devices, medicine’s incredibly shrinking machines — cardiac implants, pill cameras, a bionic “eye” — and a host of other Lilliputian automatons still on the drawing board.
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“I walked into the hospital at 10 a.m. and the procedure started around 12,” Johnson said. “In 24 hours I was home.”
The cardiac implant, a product of St. Jude Medical, a Minnesota-based medical device maker, is called Nanostim and is being tested for safety and efficacy in a multicenter clinical trial.
Dr. Joseph Levine, director of the Arrhythmia and Pacemaker Center at St. Francis Hospital in Roslyn, said in many ways Johnson is a pioneering patient — the first on Long Island to receive the device.
“This is very different from a standard pacemaker,” Levine said of an implant only slightly larger than a quarter.
“A person can go to the beach and people will not know that the person has a pacemaker,” Levine said, adding that he thinks it’s ideal for younger, active heart patients.
A standard pacemaker, by comparison, is a much bulkier device that must be implanted in the shoulder region in an operation performed by a surgeon. Those devices also have a lead wire, which is threaded from the pacemaker to the heart.
“Getting rid of the lead was a good approach,” Levine said.
Levine and Dr. Richard Shlofmitz, chairman of cardiology at St. Francis, implanted the device in a 20-minute procedure.
The device is routed into the right ventricle of the heart using a catheter inserted in the femoral vein of the leg, said Levine, a specialist in electrophysiology.
In time, scar tissue grows over the implant and secures it in place.
Nanostim is for patients who require single-chamber pacing, or roughly 20 percent to 30 percent of patients who require a pacemaker.
Many patients require pacing in dual chambers of the heart and would not be candidates, he said.
More than 4 million patients globally have pacemakers, and 700,000 new patients receive one annually, World Health Organization statistics show.
Johnson required one because he suffered from fainting spells and has a slow heartbeat.
The device was designed to treat bradycardia, a slow heart rate. It works by monitoring cardiac electrical rhythms, sending an electrical stimulation when a beat is too slow.
Levine and Shlofmitz are participating in a trial in which the device is being implanted in as many as 1,000 patients nationwide at 50 centers.
The trial is being led by Dr. Vivek Reddy of The Mount Sinai Hospital in Manhattan, the first physician in the world to implant the tiny pacemaker.
Reddy traveled to Prague two years ago to insert the device in a Czech heart patient during the European clinical trial, which he also led.
“The device is already approved in Europe,” Reddy said Friday.
The average age of patients receiving the device in Europe, he said, was 77, and two-thirds were men at two hospitals in Prague and one in Amsterdam.
European regulators tend to approve devices more rapidly than the U.S. Food and Drug Administration, Reddy said.
“There were just over 30 patients in whom we implanted this device,” he said, adding the implant “paced properly and patients improved.”
He said the device has a battery that lasts 10 years.
At the end of the battery’s life, he said patients can receive a new device, implanted in the same heart chamber without removing the old one.
Unlike Levine, Reddy sees the pacemaker as one that meets the needs of an older population because slow heartbeats are more likely among those who’ve aged as opposed to those who are young.
The first U.S. patient to receive the tiny pacemaker was implanted with the device in February by Reddy.
Gregory Dobin, 83, of Brooklyn said he’s pleased he underwent the procedure.
He needed the pacemaker to treat a slow heartbeat, which caused him to have a pulse rate of only about 35 to 40 beats per minute, Reddy said.
“I am excited,” said Dobin, referring to his invigorated heartbeat. “My pulse is now in the 60s, and I am excited since everyone wants to live longer. I am looking forward to follow-up in 10 years.”
Pacing the heart with electrical devices has a long and storied past.
The late Dr. Judah Folkman — best known for cancer research and the concept of killing tumors with drugs that choke off their blood supply — invented the first implantable heart pacemaker more than 50 years ago.
Johnson, meanwhile, who has been back to work for two weeks, is already increasing his hours.
“I took it easy right after the procedure, working only eight hours a day. Now, I am back to 14 hours,” he said.