Next-generation pacemakers in development are less than 10% the size of conventional pacemakers, leadless, and do not require surgery to implant. These self-contained devices house a battery, electronics, and electrodes. They are able to sense and pace in only one heart chamber, so they are considered appropriate for only about 15% of patients requiring a pacemaker. Nonetheless, the hope is that this new generation of pacemakers will improve safety, comfort, and quality of life for some patients compared to existing devices.
Two companies are in the race to the U.S. market with a leadless pacemaker: St. Jude Medical, Inc. (St. Paul, MN, USA) makes the Nanostim Leadless Pacemaker, and Medtronic, plc (Dublin, Ireland) makes the Micra Transcatheter Pacing System (TPS). Both devices have received the CE mark within the past two years and are commercially available in Europe, but not in the United States, where late-phase clinical trials are ongoing to generate data for premarket approval submissions to FDA.
Nearly 3 million U.S. patients had a pacemaker implanted between 1993 and 2009, with overall pacemaker use increasing by 56% during that period. Although pacemaker use in most patients is uneventful, about 4% of patients encounter device-related complications, including lead migration, other lead failure, or implant-related infection, typically in the subcutaneous pocket housing the pacemaker. Also, implanting the pulse generator subcutaneously in the chest can cause a visible lump or scar and somewhat reduce arm mobility.
The leadless single-chamber cardiac pacing devices are implanted directly into the right ventricle via a transcatheter approach. Possible candidates for the devices include patients with permanent atrial fibrillation with bradycardia who meet standard pacemaker indications, patients with sinus rhythm with a low level of physical activity or short expected lifespan, and patients with sinus bradycardia with infrequent prolonged pauses or unexplained syncope.
To implant a leadless pacemaker, an interventional cardiologist, typically an electrophysiologist, inserts the steerable delivery catheter at the femoral vein in the groin or jugular vein and advances it to the apex of the right ventricle under fluoroscopic guidance. The device does not have a separate pulse generator and requires no surgical pocket, like a standard pacemaker. The procedure takes about 30% to 60% of the time required for a conventional pacemaker implantation. The pacemaker is attached using a fixation mechanism, and the pacing and sensing system are tested with the device still connected to the catheter. Once deployed and detached from the catheter, the leadless pacemaker can be repositioned or retrieved if necessary. Generally, the patient is observed for 24 hours before discharge. The battery reportedly lasts from about 9.5 years up to 15 years, depending on pacing parameters.
What to do if you are considering this technology
According to ECRI Institute’s PriceGuide database, the average price paid for the Nanostim leadless pacemaker, as reported by member hospitals, was $9,000, and the average price for the Micra TPS was $9,500. A recent review article estimated additional procedure implantation costs of about $4,000/case. In Australia, the Health Policy Advisory Committee on Technology in a July 2015 report on leadless pacemakers indicated that costs were nearly three times higher than for conventional pacemakers.
A 2014 article by two cardiologists reported that lack of billing codes specific to leadless pacemakers caused many centers participating in U.S. clinical trials to perform procedures at a financial loss. Trial sites reported difficulty securing adequate reimbursement to cover the costs for leadless pacemaker implantation from local Medicare contractors, with many cases reimbursed under a code designated for a conventional single-chamber pacemaker with lead implantation.
However, in January 2015, the American Medical Association established specific temporary Current Procedural Terminology (CPT) codes that describe transcatheter insertion or replacement of a leadless pacemaker, transcatheter removal of a leadless pacemaker, and in-person programming and interrogation evaluations. These temporary codes facilitate data collection and set the stage for introduction of permanent codes to facilitate reimbursement if FDA approves leadless pacemakers.
Stay tuned! In future issues of TechNation, we’ll take a deeper dive into more of the topics featured on ECRI Institute’s 2016 Top 10 Hospital C-Suite Watch List.
This article is excerpted from ECRI Institute’s 2016 Top 10 Hospital C-Suite Watch List. The full report contains an in-depth miniature leadless pacemaker evidence story. To download the full report, visit www.ecri.org/2016watchlist. For more information on ECRI Institute’s evidence-based health technology assessment or consulting services, contact firstname.lastname@example.org, or call (610) 825-6000, ext. 5889.
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