Pill-size apparatus helps regulate hearts

An 86-year-old Oahu man who suffers from an abnormal heartbeat and shortness of breath Wednesday became the first person in Hawaii to be implanted with the world’s smallest pacemaker.

Inserting the pill-size pacemaker took just 65 minutes — a procedure that Dr. Edward Shen, a surgeon at The Queen’s Medical Center, expects to replicate many more times this year.

“Oh, for sure, absolutely,” Shen said while sitting next to his patient, Robert Yung, who has homes in Hawaii Kai and Ala Moana.

For the last three years, Yung has been diagnosed with a slow heart rate that would often drop to 45 beats per minute, leading to low blood pressure.

Yung would often lose his breath while golfing with his pals, most of whom rely on old-school pacemakers that bulge like a tin of breath mints beneath their skin and attach to their hearts with electrical leads.

Yung is now the first island patient to have the “Micra Transcatheter Pacing System” inserted through his groin and implanted directly into his heart via a catheter, where it remains attached thanks to four miniature grappling hooks that Shen deployed remotely via the catheter.

The bulk of the procedure — 40 minutes — was spent repairing the entry point for the catheter in Yung’s groin, Shen said. Inserting the pacemaker directly into Yung’s right ventricle took only 25 minutes.

Yung was awake during the procedure and said he felt only pressure on his right leg as the catheter was inserted.

Although he said the operation “wasn’t dramatic,” Yung is amazed at the technology now inside him, designed to control his heart rate with far less hardware, reduced risk of complications and a battery life that’s expected to last 12 to 14 years versus seven to 10 years.

From an aesthetic standpoint, the pacemaker cannot be seen or felt, Yung said. It’s also designed to hold up under magnetic resonance imaging, more commonly known as an MRI.

“It’s amazing,” Yung said. “I’m so pleased.”

Unlike the pacemakers that his golfing buddies rely on, Yung’s has no wire leads that can malfunction — or a surgically created “pocket” that holds the pacemaker in place and could lead to infections.

Just getting a patient’s “pocket” to heal properly can take four to six weeks, Shen said.

He called the new pacemaker “low-risk, comfortable, easier to implant.” After the surgery, Shen said, a “patient can be awake and walking within three hours.”

The technology, Yung said, “is almost ‘Star Wars.’”

Instead of trying to remove Yung’s pacemaker someday to replace the battery, it’ll be far simpler and safer to just install an entirely new pacemaker, turn the old one off electronically and leave it in, Shen said.

The U.S. Food and Drug Administration approved the system in April 2016. On its website the FDA said the so-called “Micra TPS is indicated to be used in patients who have slow or irregular heart rhythms and who may benefit from a single chamber pacemaker system or when placement of a traditional system is difficult.”

One of the FDA’s Q&A entries is, “When should it not be used? There are no known contraindications for the use of pacing as a therapy to control heart rate. The patient’s age and medical condition may influence the selection of the pacing system, the mode of operation, and the implant technique used by the physician.”

Shen implants 250 to 300 pacemakers annually. He is the first Hawaii surgeon to undergo training on the new pacemakers at Medtronic, the Minneapolis-based company behind the new technology, said Sarah Jabari, a Medtronic technical field engineer.

In January, Shen underwent a day of training in Minnesota “to get certified to implant the device,” said Jabari, who was there.

Implanting the first pill-size pacemaker in Hawaii is just the latest surgical milestone for Shen.

He’s already credited in the islands for the first cases of “automatic implantable cardioverter-defibrillator” (1987), “catheter ablation of supraventricular tachycardia” (1989), “coronary atherectomy” (1991), “catheter ablation of ventricular tachycardia” (1992), “intracoronary stent” (1993), “biventricular pacemaker” (2001) and “laser transvenous lead extraction” (2008).

Yung said of his surgeon, “His credentials are impeccable.”

Yung was released from Queen’s on Thursday. If all goes as expected, he plans to play his next round of golf in four weeks.

But unlike his golfing buddies whose pacemakers stick out of their chests, Yung will have no physical evidence of the new technology now keeping his heart beating on schedule.