Archived Policies - Surgery
Leadless Cardiac Pacemaker
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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 the Micra (Medtronic, Minneapolis, Minnesota) and Nanostim (St. Jude Medical, St. Paul, Minnesota).
In April 2016, the U.S. Food and Drug Administration (FDA) approved the premarket application for the Micra Transcatheter Pacemaker Model MC1VR01 and Programmer Application (P150033).
In October 2016, St. Jude Medical halted further Nanostim implantations in the LEADLESS II Investigational Device Exemption/Continued Access Protocol study due to battery malfunctions. As of March 2017, Nanostim did not have FDA marketing approval in the United States. (1)
This policy was created in December 2015 and has been updated periodically with literature review via the MedLine database. The most recent update with literature search was completed through August 2017.
Reddy et al. 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) (2). 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 et al. tested the early performance of a novel self-contained miniaturized pacemaker. (3) 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, <2 V 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 et al. reported 6-month data on their "primary cohort" of 300 patients. (4) 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 et al. 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.
In 2016, Reynolds et al. published a prospective, multicenter, single-arm study of 719 subjects implanted with the Micra Transcatheter Pacemaker System (TPS) with two primary outcomes: efficacy and safety. (5) Enrolled subjects met either class I or II indications for pacing and were candidates for single-chamber pacing. The majority (64.0%) had bradycardia associated with persistent or permanent atrial tachyarrhythmia, 17.5% had sinus node dysfunction, 14.8% had atrioventricular (AV) block. A planned interim analysis was completed when 300 subjects reached 6 months of follow-up. The primary efficacy endpoint, the percent of subjects with low and stable pacing capture thresholds at 6 months, was 98.3% (95% confidence interval [CI], 96.1-99.5; p<0.001). The primary safety endpoint, freedom from system-related or procedure-related major complications, was 96.0% (95% CI, 93.9-97.3; p<0.001). Additionally, safety outcomes were compared to historic controls from 6 previous transvenous pacemaker trials. While there were significant differences between the study and control subjects, the implanted study group experienced fewer hospitalizations (2.3% vs. 3.9%) and fewer system revisions (0.4% vs. 3.5%). This clinical trial will continue to follow subjects for at least an additional 12 months to evaluate the long-term performance of the Micra TPS. The evidence from this study is considered preliminary and insufficient to demonstrate the long-term safety and efficacy of the Micra TPS, as compared to conventional pacemaker devices.
An UpToDate article noted the following 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.” (6)
In 2017, ECRI completed a product brief for the Micra TPS (Medtronic Plc, Dublin, Ireland) and concluded the following:
“The Micra TPS is an effective pacemaker in patients with bradycardia from atrial tachyarrhythmia, sinus-node dysfunction, or atrioventricular (AV) node dysfunction. The Micra Transcatheter Pacing Study reported a 99.2% implantation success rate, major complication rate of 3.5%, and stable pacing capture thresholds of 98.3% at 6 months. Survival data at 2- and 5-year follow-up will be available from ongoing trials. No studies have directly compared Micra TPS to transvenous-lead pacemakers. “ (7)
Centers for Medicare and Medicaid Services (CMS)
In January 2017, CMS issued a Decision Memo stating that it will only cover leadless pacemakers through Coverage with Evidence Development (CED) program. (8) CMS will cover leadless pacemakers when procedures are performed in FDA-approved studies, in accordance with FDA label and when furnished as part of CMS-approved post-approval studies, or prospective longitudinal studies meeting criteria.
The following is also included in the CMS Decision Memo:
“CMS believes that the evidence is promising and sufficient for coverage of leadless pacemakers when furnished in CMS-approved studies under CED. CMS believes that the available evidence is not sufficient to determine long term health outcomes or to identify the characteristics of the patient, practitioner or facility that predict which beneficiaries are more likely to experience overall benefit or harm from leadless pacemakers. Significant questions remain regarding the potential for deterioration in left ventricular function and other long term outcomes, as well as device longevity.”
“These devices have not been tested in broader, long term studies that include real world practice settings and are currently being followed in FDA-required post market studies.”
Summary of Evidence
A leadless cardiac pacemaker has been designed to reduce the risks of electrode lead failure and device related infection due to surgical pockets needed from a conventional cardiac pacemaker. The available evidence from published literature includes two prospective, nonrandomized, single-arm multicenter studies followed to 3 months; a 6 month non-phased, non- randomized, open label interventional study; and a 12- month, phase III, open-label, single-group assignment study. It was concluded that the 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, however, the evidence from these studies is considered insufficient to demonstrate the long-term safety and efficacy of the leadless cardiac pacemaker.
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Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.
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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
ICD-9 Diagnosis Codes
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ICD-9 Procedure Codes
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ICD-10 Diagnosis Codes
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ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. ECRI Institute. Leadless Pacemakers for Cardiac Single-chamber Pacing. Plymouth Meeting (PA): ECRI Institute; 2017 April. 16 p. (Health Technology Forecast).
2. Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. Apr 8 2014; 129(14):1466-71. Epub 2014 Mar 24. PMID 24664277
3. Ritter P, Duray GZ, Steinwender C, et al. Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study. Eur Heart J. Oct 1 2015; 36(37):2510-9. PMID 26045305
4. Reddy VY, Exner DV, Cantillon DJ, et al. Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker. N Engl J Med. Sept 17 2015; 373(12):1125-1135. PMID 26321198
5. Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. Feb 11 2016; 374(6):533-41. PMID 26551877
6. Hayes, DL. Permanent cardiac pacing: Overview of devices and indications. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available at <http://www.uptodate.com> (accessed - 2017 September 5).
7. ECRI Institute. Micra Transcatheter Pacing System (Medtronic, Plc.) for Cardiac Single-chamber Pacing. Plymouth Meeting (PA): ECRI Institute; 2017 July. 13 p. (Product Brief).
8. CMS – Decision Memo for Leadless Pacemakers (CAG-00448N). National Centers for Medicare and Medicaid Services. Available at <https://www.cms.gov> (accessed - 2017 September 5).
|11/15/2017||Document updated with literature review. Coverage unchanged.|
|5/15/2016||Reviewed. No changes.|
|12/15/2015||New medical document. Leadless cardiac pacemakers are considered experimental, investigational and/or unproven for all indications.|