Archived Policies - Surgery
Leadless Cardiac Pacemaker
Leadless cardiac pacemakers are considered experimental, investigational and/or unproven for all indications.
Early pacing devices offered single-chamber, fixed-rate ventricular pacing for life-threatening conduction system disease. Advances in generator and lead technology and the results of clinical trials over the past 60 years have expanded the indications for device therapy. As a result, more individuals are receiving device therapy; approximately 190,000 pacemakers are implanted every year in the United States.
Recently leadless cardiac pacemakers have become available. A leadless cardiac pacemaker includes a long-lived battery and a steroid-eluting electrode that sends pulses to the heart when it recognizes a problem with the heart’s rhythm. Unlike traditional pacemakers, a leadless pacemaker is placed directly in the heart without the need for a surgical pocket and transvenous lead implantation. The device is implanted using a catheter inserted through an incision near the groin and threaded up the femoral vein to the right ventricle. Because the implant procedure does not require surgery like a traditional procedure, it is considered a less-invasive approach for patients who need pacemaker technology.
The two leadless pacemakers currently in the development process are, Nanostim (St. Jude Medical, St. Paul, Minnesota) and Micra (Medtronic, Minneapolis, Minnesota.). To date, no leadless pacemakers are U.S. Food and Drug Administration (FDA) approved, however both Nanostim and Micra have CE Marking in Europe and are currently undergoing late-stage trials.
Reddy and colleagues conducted a prospective nonrandomized study, with an indication for single chamber right ventricular (RV) pacing. In this Leadless Trial, the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker was tested. The leadless device was successfully implanted via transfemoral venous approach in 32 of 33 patients (97 percent) (1). The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. The authors note this completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible and that the absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing.
In the Micra Transcatheter Pacing Study, Ritter tested the early performance of a novel self-contained miniaturized pacemaker. (2) Enrollment included 140 patients with Class I or II indication for VVI (ventricular) pacing. The patients underwent implantation of a Micra transcatheter pacing system. The leadless device was successfully placed in all 140 patients (100 percent) by 37 clinicians in 23 centers. One of two primary endpoints, freedom from device-related adverse events at 90 days, was achieved in all 140 patients (100 percent). The second primary endpoint, <2V mean pacing capture threshold at 0.24 millisecond pulse width, was assessed in a subset of patients and was achieved in all 60 patients who were seen at three-month follow-up.
In the Leadless II Trial Reddy and colleagues reported 6-month data on their "primary cohort" of 300 patients. (3) The intention-to-treat primary efficacy endpoint was met in 270 of 300 patients (90%; 95% confidence interval [CI], 86.0 to 93.2, p = 0.007), and the primary safety endpoint—freedom from device-related adverse events—was met in 280 of 300 patients (93.3%; 95% CI, 89.9 to 95.9; p <0.001). Device-related serious adverse events were observed in 6.7% of patients; events included device dislodgement with percutaneous retrieval (1.7%), cardiac perforation (1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (1.3%). The Leadless II trial is ongoing, with 526 patients enrolled as of June 2015. Reddy and colleagues concluded the results showed "effective pacemaker function in a varied group of patients who had indications for long-term pacing therapy." The overall condition of the patients was comparable to that of patients who receive conventional pacemakers, but with higher rates of hypertension, hyperlipidemia, and diabetes.
UpToDate 2015 (4)
In a 2015 UpToDate article, the following is noted regarding leadless systems: “Leadless cardiac pacing holds promise as a long-term permanent cardiac pacing option for patients requiring single ventricle (RV only) pacing. However, longer-term follow-up is needed to assess the safety and efficacy of these devices. The potential for and incidence of long-term deleterious effects of pacing only the RV, will also need to be assessed.”
ECRI 2014 (5)
“No leadless pacemaker is commercially available in United States at this time; the Nanostim is available in some European countries. Very preliminary evidence from conference abstracts on the Nanostim report some results from the same ongoing clinical trial. The results suggest that the Nanostim leadless pacemaker might be effective for treating bradycardia. Available information is insufficient to determine whether it is as safe and effective as, or more safe and effective than, conventional pacemakers.”
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The following codes may be applicable to this Medical policy and may not be all inclusive.
0387T, 0388T, 0389T, 0390T, 0391T
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1. Reddy VY, Knops RE, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr; 129(14):1466-71. Epub 2014 Mar 24.
2. Reddy, V., Exner, D., et al. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. September 2015; 373:1125-1135. 710.023
3. Ritter P, Duray GZ, et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J. 2015 June.
4. Hayes, DL, Permanent cardiac pacing: Overview of devices and indications. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on October 13 2015).
5. ECRI Institute. Nanostim Leadless Pacemaker (St. Jude Medical, Inc.) for Managing Cardiac Rhythm. Plymouth Meeting (PA): ECRI Institute; 2014 January. 5 p. (Custom Product Briefs - Guidance).
6. Mayo Clinic Clinical updates. Leadless pacing available for selected patients. December 2015 http://www.mayoclinic.org Last accessed October 2015.
|12/15/2015||New medical document. Leadless cardiac pacemakers are considered experimental, investigational and/or unproven for all indications.|