New York, 11 February 2014: An Indian-origin doctor in the US has implanted the first
miniature-sized, leadless cardiac pacemaker directly inside a patient’s heart without
surgery. The lead-free pacemaker is implanted directly inside the heart during a catheter-guided
procedure through the groin via the femoral artery.
The device implanted by
Vivek Reddy from The Mount Sinai Hospital resembles a small metal silver tube, and
is only a few centimeters in length, making it less than ten percent the size of a
traditional pacemaker, The Times of India reported.
The Nanostim device, made
by St Jude Medical, is being tested for safety and efficacy in an international, multicenter
clinical trial called LEADLESS II, which is planning to enroll 670 patients at 50
centers across the US, Canada, and Europe.
“This clinical research trial will
be testing the latest innovative, non-surgical pacemaker option for patients experiencing
a slowed heart beat,” said Reddy, the study’s co-investigator.
“This new-age,
tiny pacemaker may ultimately be safer for patients because it doesn’t have leads
or have to be inserted under the skin of a patient’s chest, like a traditional cardiac
pacemaker,” Reddy said.
Similar to other cardiac pacemakers, the Nanostim device
treats a heart rate that is too slow called bradycardia.
It works by closely
monitoring the heart’s electrical rhythms and if the heart beat is too slow it provides
electrical stimulation therapy to regulate it. More than 4 million patients globally
have a pacemaker, and 700,000 new patients receive one each year, researchers said.
The
possible advantages of the leadless pacemaker include the elimination of a surgical
pocket and no visible pacemaker device under a patient’s chest skin, no incision scar
on the chest, no connector wires or leads, and no restrictions on a patient’s activities.
The
device’s benefits may also allow for less patient discomfort, infections, and device
complications and dysfunction.
In addition, the free-standing, battery-operated
pacemaker device is designed to be fully retrievable from the heart.
“The same
cardiac pacing results for patients may be available with this smaller leads-free
device with the added benefits of a non-surgical procedure and less complication risks,”
said Srinivas Dukkipati, who is the study’s principal investigator. Source: Mattersindia