Medical Policy: 01.01.28
Original Effective Date: December 2015
Reviewed: November 2018
Revised: November 2018
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
The leadless cardiac pacemaker (Nanostim Inc., Sunnyvale, Calif.) is an entirely self-contained intra-cardiac device with a screw-in active fixation mechanism. After placing an 18F sheath in the femoral vein, the device is delivered to the right ventricle using a deflectable delivery catheter with an extendable sleeve to protect the fixation helix. Once positioned, the sleeve is retracted and the device is undocked from the delivery catheter while maintaining a tethered connection to permit device measurements and assess stability. If the position is suboptimal, the leadless pacemaker can be re-engaged, unscrewed and repositioned.
Unlike a standard pacemaker, a leadless pacemaker does not require creation of a surgical pocket for the pacemaker, and it requires no leads. Advantages of a leadless pacemaker over a standard pacemaker is avoidance of a surgical scar or lump under the skin where the pacemaker sits. The pacemaker battery life is equivalent to that of similar standard single chamber pacemakers. Additional potential advantages include avoidance of problems with lead placement and reduction in risk of infections.
The Nanostim leadless cardiac pacemaker met pre-specified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials.gov number, NCT02030418.)
The Micra (Medtronic) leadless pacemaker is similar in concept to the Nanostim leadless cardiac pacemaker (St Jude Medical), another device that is further ahead in testing. The two pacemakers differ slightly in terms of how they are lodged into the myocardium of the RV apex, however.
Another concept in leadless pacing is a multi-component ultrasound-based LV endocardial pacing system for cardiac resynchronization therapy: the WiCS system (Wireless Cardiac Stimulation, EBR systems, Sunnyvale, CA, USA). The (WICS®, EBR Systems, Inc.) effectively adds Cardiac Resynchronization Therapy (CRT) capability to an existing transvenous PM/ICD. It uses a pulse generator or receiver electrode delivered to the left ventricular endocardium via the transfemoral retrograde aortic approach and is powered by an ultrasound transmitter implanted in the chest wall. The WiSE CRT System uses a proprietary wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart.
The FDA clearance of the leadless device was based on an evaluation of data from a single study. This was a prospective, multicenter, single-arm study of 719 subjects implanted with the Micra TPS with two primary outcomes: efficacy and safety. 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.
The complication rate of the leadless pacemakers is influenced by the implanter learning curve for this new procedure. No long-term outcome data are yet available for the leadless pacemakers. Larger leadless pacing trials, with long-term follow-up and direct randomized comparison with conventional pacing systems, will be required to define the proper clinical role of these leadless systems. Although current leadless pacemakers are limited to right ventricular pacing, future advanced, communicating, multicomponent systems are expected to expand the potential benefits of leadless therapy to a larger patient population.
Evidence on the safety of leadless cardiac pacemaker implantation for bradyarrhythmias shows that there are serious but well-recognized complications. The evidence on efficacy is inadequate in quantity and quality:
Clinicians wishing to do leadless cardiac pacemaker implantation for bradyarrhythmias in people who cannot have conventional cardiac pacemaker implantation should:
Leadless/Wireless Cardiac pacemakers including, but not limited to the Nanostim, Micra devices, and WICS®, EBR Systems are considered investigational.
The short performance of leadless cardiac pacemakers is available, the intermediate and long-term performance of these devices requires significantly more published data. The unknown long term outcomes, coupled with the adverse event concerns during clinical trials indicate there is insufficient evidence on long term effectiveness and overall net health outcomes. Studies have mostly been limited to clinical trials with less than 2 years follow-up and they often failed to reflect real population outcomes. Additional studies are necessary to evaluate the safety, efficacy and stability of leadless pacemakers. Removal of the device, re-implantation, battery life questions, true comparison to transvenous systems and other noted complications are currently uncertain.
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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