Breakthrough in Cardiology: Medtronic's Cardiac pacemakers without leads June 27, 2016 14:25
For decades patients who have had a slow heart rate have been managed with a pacemaker with leads being implanted into the right ventricle and right atrium. The procedure requires some type of anesthesia and use of x-rays to ensure that the lead placement was correct. In most cases, the subclavian vein in the neck is percutaneously cannulated through which the lead is placed in the heart. The lead is then hooked up to a generator, which is then placed underneath the collarbone. The device is fairly large and once the pacemaker is inserted, there are many lifestyle restrictions
This procedure is effective for treatment of slow heart rate but is also fraught with complications like lead dislodgement, cracks in the lead and infections, which account for 2-10 percent of cases. When the leads fail to work, removal is a very difficult and exhaustive procedure with potentially life threatening complications like ventricular rupture. Over the years, millions of Americans have received these pacemakers. Since the 1980s, pacemaker technology has not changed much.
However, just last year researchers developed a lead-less pacemaker, the size of a large vitamin pill. This wireless miniaturized battery controlled pacemaker can be implanted directly into the right heart muscle via the femoral vein within 10-20 minutes. The pacemaker is secured into the heart muscle by hooks or a screw. The device contains a sensor electrode inside the metal clad device that detects all the heart information and relays it to the generator, which provides the necessary cardiac stimulation to keep the heart beating at the set rate. The lithium battery in this miniature device is estimated to last 7-12 years. The entire wireless device can easily be retrieved via a catheter if a new battery is required.
This novel pacemaker based on nano technology has eliminated scars and an incision on the patient’s chest. Further there are no restrictions on physical activity nor are there any problems associated with malfunctioning leads. The FDA just approved the first wireless pacemaker (Micra) last month for use in the USA. Several large clinical trials are now in progress to test this particular device.
At the moment the Micra pacemaker is a great option for patients who need stimulation of only a single chamber. The Micra pacemaker has been tested and approved to be safe in presence of MRI scanners. One can walk through airport metal security without any interference to the pacemaker. Use of this pacemaker will cut down on hospital admission, the surgeon and anesthesiologist fees, and the need for x-ray during the procedure.
The only downside is the cost of this device. It is estimated that this wireless pacemaker will cost anywhere from $10,000- $15,000 which is many times more expensive than the conventional pacemakers which cost about $2,500. With cost cutting measures in most hospitals, there is concern that these devices may not catch on fast. Further Medicare has already stated that it has no extra budget and it is not known if it will pay for the extra cost.