| Coverage Policy Manual | |
| Policy #: | 2011062 |
| Category: | Surgery |
| Initiated: | September 2011 |
| Last Review: | September 2023 |
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| Electrical Stimulation, Baroreflex Stimulation for the Treatment of Hypertension | |
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| Description: |
Baroreflex stimulation devices are used to provide baroreflex activation therapy® (BAT®) which refers to electrical stimulation of the baroreceptors in the carotid arteries by means of an implanted device. Activation of the baroreflex causes inhibition of the sympathetic nervous system, resulting in a variety of physiologic changes including slowed heart rate and decreased blood pressure. Use of baroreflex stimulation devices has therefore been proposed as a treatment for hypertension that is resistant to standard medications, as well as related conditions which are associated with high sympathetic tone.
The baroreceptors are pressure sensors contained within the walls of the carotid arteries. They are part of the autonomic nervous system that regulates basic physiologic functions such as heart rate and blood pressure. When these receptors are stretched, as occurs with increases in blood pressure, the baroreflex is activated. Activation of the baroreflex sends signals to the brain, which responds by inhibiting sympathetic nervous system output and increasing parasympathetic nervous system output. The effect of this activation is to reduce heart rate and blood pressure, thereby helping to maintain homeostasis of the circulatory system.
The use of baroreflex stimulation devices (also known as baroreflex activation therapy) is a potential alternative treatment for resistant hypertension and heart failure. Both hypertension and heart failure are relatively common conditions and are initially treated with medications and lifestyle changes. A substantial portion of patients are unresponsive to conventional therapy and treating these patients is often challenging, expensive, and can lead to adverse events. As a result, there is a large unmet need for additional treatments
Regulatory Status
In 2014, the Barostim neo® Legacy System (CVRx, Minneapolis, MN) received a humanitarian device exemption from the Food and Drug Administration (FDA) for use in patients with treatment-resistant hypertension who received Rheos® Carotid Sinus leads as part of the Rheos pivotal trial and were considered responders in that trial (FDA, 2014).
In 2019, Barostim Neo™ was granted premarket approval (PMA P180050) and is indicated for the improvement of symptoms of heart failure (ie, quality of life, six-minute hall walk, and functional status) for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are New York Heart Association (NYHA) Class III or Class II ( with a recent history of Class III), and have a left ventricular ejection fraction ≤35% and a N-terminal pro-B-type natriuretic peptide (NT-proBNP) <1600 pg/ml, excluding patients indicated for Cardiac Resynchronization Therapy according to the American Heart Association/American College of Cardiology/European Society of Cardiology guidelines.
It was the first device to be granted approval via the Expedited Access Pathway (FDA, 2019; Zile, 2018). The Expedited Access Pathway will hasten the approval of novel therapies that target life-threatening conditions.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of baroreflex stimulation implanted devices to treat hypertension or any other indication does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. Primary coverage criteria excludes services that are being studied in Phase I, II, or III clinical trials.
For members with contracts without primary coverage criteria, the use of baroreflex stimulation implanted devices to treat hypertension or any other indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
A literature review was performed for the period of January 1, 2000 to June 30, 2011, focusing on identification of controlled trials, particularly randomized controlled trials (RCTs), or prospective cohort studies. The evidence identified consists of several small, single-arm feasibility trials and preliminary results from an RCT presented at a scientific meeting. All of the available trials enrolled patients with resistant hypertension.
The largest published study to date is the DEBut-HT trial, (Scheffers, 2010) which was a multicenter, single-arm feasibility trial of the Rheos® BAT system. This trial enrolled 45 subjects, from 9 clinical centers in Europe, with resistant hypertension defined as a blood pressure of greater than 160/90 despite treatment with at least 3 antihypertensive drugs, including a diuretic. The planned follow-up period was 3 months, with a smaller number of patients followed for up to 2 years. In 37 patients completing the 3-month protocol, systolic office blood pressure (BP) was reduced by 21+4 mm Hg (p<0.0001) and diastolic BP was reduced by 12+2 mm Hg (p<0.001). There was a smaller reduction in 24-hour ambulatory BP (n=26), with a decrease of 6+3 mm Hg in systolic BP (p=0.10) and a decrease of 4+2 mm Hg in diastolic BP (p=0.04). In 26 patients followed for 1 year, the declines in office BP were 30+6 mm Hg systolic (p<0.001) and 20+4 mm Hg diastolic (p<0.001). For ambulatory BP (n=15), the 1-year declines were 13+3 mm Hg systolic (p<0.001) and 8+2 mm Hg diastolic (p=0.001). A total of 7/42 patients (16. 7 %)experienced adverse events. Three patients required device removal due to infection; one patient experienced perioperative stroke; one patient experienced tongue paresis due to hypoglossal nerve injury; one patient had postoperative pulmonary edema; and one patient required reintervention for movement of the device.
Several other smaller feasibility trials have been reported. For example, Heusser et al. ( Heusser) treated 12 individuals who had treatment- resistant hypertension with the Rheos® system. The mean baseline BP was 193/94 mm Hg, and at 1 month following implantation, there were decreases in systolic BP of 3 +10 mm Hg (p=0.01). The decrease in diastolic BP was not reported. Tordoir et al. (Tordoir, 2007) treated 21 patients with the Rheos® system and reported acute decreases in BP at one to three days post-implantation. The mean baseline BP was 189.6/110.7mm Hg, with a reduction post-treatment of 28 +/-22mmHg systolic, and 16 +/-11 diastolic. Adverse events reported included infection necessitating removal (n=1), hypoglossal nerve injury (n=1), wound complications (n=3); intraoperative bradycardia (n=2); and pain (n=5).
Bisognano and colleagues reported the results of a randomized controlled trial, the Rheos® pivotal trial, (Bisognano, 2011). This trial is a double-blind, randomized trial of 265 patients. All patients had the Rheos® system implanted, and patients were randomized to the device turned on or off in a 2:1 fashion. At six months, 42% of the patients in the active treatment group reached a target systolic BP of 149, compared with 24% in the control group (p value not reported). The target outcomes were not met for short term efficacy, defined as the percent of patients with at least a 10mm Hg drop in BP, and safety, defined as freedom from adverse events in >82% of patients.
A search of online site ClinicalTrials.Gov revealed the following ongoing trials listed:
The Rheos® Feasibility Trial (NCT01077180): This single-armed study of 16 patients is a Phase II study intended to assess safety, device performance, and protocol parameters of the Rheos® system in patients with resistant hypertension. The current status is listed as ongoing but not recruiting participants. The estimated completion date is March 2012.
The Rheos® HOPE4HF Trial (NCT00957073): This randomized trial of 540 patients is intended to assess the safety and efficacy of the Rheos® system in patients with heart failure and preserved ejection fraction. Primary outcomes include a composite of cardiovascular death/heart failure events and procedure-related complications; secondary outcomes include cardiovascular events, changes in left ventricular mass, and changes in quality of life. The current status is listed as currently recruiting participants. The estimated completion date is December, 2014.
The use of baroreflex stimulation devices is a potential alternative treatment for resistant hypertension. At least one device is in the development stages, but has not received FDA approval for any indications. Small, uncontrolled feasibility studies report short-term reductions in blood pressure, together with adverse evenets such as infection, hypoglossal nerve injury, and wound complications. Preliminary results of an RCT have been presented at a scientific meeting, but not yet published in a peer-reviewed journal. These results report that more patients in the treatment group reached a target systolic BP at six months, but that the main BP efficacy endpoints and the main safety endpoints were not met. Further research from RCTs is needed to determine whether baroreflex activation therapy is effective in reducing blood pressure for patients with resistant hypertension.
2012 Update
A search of the MEDLINE database was conducted through September 2012. The following is a summary of articles reviewed:
Hoppe et al. (2012) published the results of a single-arm series of 30 patients treated with a “second-generation” device, called the Barostim neo™ (CVRx™, Minneapolis, MN). This system consists of a unilateral electrode and lead that is attached to the carotid sinus and a pulse generator that is implanted subcutaneously in the chest wall. Programming is performed via radiofrequency telemetry using an external laptop computer and software. Thirty patients from 7 centers in Europe and Canada with resistant hypertension were treated with this device and followed for a 6-month period. The mean baseline BP was 172/100. At 6 months, there was a decrease in BP of 26.0 mmHg systolic and 12.4 mmHg diastolic. The percent of patients achieving adequate BP control, defined as a systolic BP or 140 or less, was 43%. There were 3 perioperative complications with the insertion sites.
A search of online site clinicaltrials.Gov revealed the following ongoing randomized, controlled trials of baroreflex stimulation therapy in addition to the ones listed above:
NCT01471834 – (Barostim Neo System in the Treatment of Resistant Hypertension) This trial is an RCT comparing baroreflex stimulation to conventional therapy in patients with resistant hypertension. The primary outcome measure is change in systolic BP at 6 months’ follow-up. Enrollment is planned for 160 participants. The status of this trial is listed as “not yet open for participant recruitment”, and an estimated completion date is not given.
NCT01471860 - (Barostim Neo System in the Treatment of Heart Failure) This trial is an RCT comparing baroreflex stimulation with medical management in patients with symptomatic heart failure despite a stable pharmacologic regimen. The primary outcome measure is change in left ventricular (LV) ejection fraction at 6 months’ follow-up. The planned enrollment is for 150 participants, with estimated completion date of February 2013. The current status of this trial is given as “not yet open for participant recruitment”.
NCT00718939 – ( Rheos® Diastolic Heart Failure) trial is an RCT that compares baroreflex stimulation with usual care in patients with clinical heart failure and an ejection fraction of 45% or greater. The primary outcome measure is change in LV mass at 6 months’ follow-up. Enrollment is planned for 60 patients, with an estimated completion date of January 2011. Although this estimated completion date has passed, there is no record of publications from this trial and current status is listed as “unknown because the information has not been verified recently.”
In summary, further research from RCTs is needed to determine whether baroreflex activation therapy is effective in reducing blood pressure for patients with resistant hypertension. Because of limited evidence showing benefit, and the lack of FDA approval, this treatment is considered investigational.
2013 Update
A search of the MEDLINE database did not reveal any new information that would prompt a change in the coverage statement.
Bakris and colleagues published data from 12 months of follow-up of patients who actively participated in the Rheos® pivotal trial (Bakris, 2012). A total of 276 of the 322 implanted patients (86%) consented to long-term open-label follow-up. After a mean follow-up of 28 months, 244 of 276 (88%) were considered to be clinically significant responders. Response was defined as sustained achievement of the target systolic blood pressure (140 mm Hg or less, or 130 mm Hg or less for patients with diabetes or renal disease), or a reduction in systolic blood pressure of 20 mm Hg or more from device activation. Alternatively, patients could qualify as a responder if their implanted device was deactivated and if they had an increase in systolic blood pressure of at least 20 mm Hg in the 30 days after device deactivation. In the extension study, there was no comparison group.
Ongoing Clinical Trials
A search of online site ClinicalTrials.Gov revealed the following ongoing randomized, controlled trials of baroreflex stimulation therapy:
CVRx Barostim Hypertension Pivotal Trial (NCT01679132) : This RCT is evaluating the safety and efficacy of the Barostim Neo device in people with treatment-resistant hypertension. Resistant hypertension is defined as a systolic blood pressure of at least 160 mm Hg, despite a stable regimen of 4 or more maximally tolerated anti-hypertensive medications. Patients will be randomized to receive optimal medical management alone or optimal medical management plus baroreflex stimulation. Primary outcomes are reduction in systolic blood pressure at 6 months and adverse events. The expected enrollment is 310 patients and the estimated date of study completion is July 2015.
Barostim Hope for Heart Failure (HOPE4HF) Study (NCT01720160) : This RCT is evaluating the safety and efficacy of the Barostim Neo device in people with heart failure. Patients will be randomized to receive optimal medical management alone or optimal medical management plus baroreflex stimulation. Primary outcomes are improvements in heart failure metrics and system and procedure-related adverse events. The expected enrollment is 60 patients and the estimated date of study completion is December 2015.
Barostim Neo System in the Treatment of Heart Failure (NCT01471860) : This is an RCT comparing baroreflex stimulation with medical management in patients with symptomatic heart failure despite a stable pharmacologic regimen. The primary outcome measure is change in left ventricular (LV) ejection fraction after 6 months’ follow-up. The planned enrollment is for 150 participants, with an estimated completion date of November 2014.
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement.
2015 Update
A literature search conducted using the MEDLINE database through August 2015 did not reveal any new information that would prompt a change in the coverage statement.
One published RCT was identified evaluating baroreflex stimulation for treatment of heart failure. This study, published by Abraham et al in 2015 was non-blinded and included 146 patients with New York Heart Association (NYHA) class III heart failure and an ejection fraction of 35% or less despite guideline-directed medical therapy (Abraham, 2015). Patients were randomized to receive baroreflex stimulation (CVRx Barostim Neo system) in addition to medical therapy (n=76) or continued medical therapy alone (n=70) for 6 months. The primary safety outcome was the proportion of patients free from major adverse neurological and cardiovascular events (MANCE). The trialists specified 3 primary efficacy end points: changes in NYHA functional class, quality of life score, and 6-minute walk distance (6MWD).
The overall MANCE-free rate was 97.2%; rates were not reported separately for the baroreflex stimulation and control groups. In terms of the efficacy outcomes, there was significant improvement in the baroreflex stimulation group versus the control group on each of the 3 outcomes. Significantly more patients in the treatment group (55%) had at least a 1-class improvement in NYHA functional class than in the control group (24%) (p<0.002). The mean quality of life score, as assessed by the Minnesota Living with Heart Failure Questionnaire, improved significantly more in the treatment group than in the control group (-17.4 points vs 2.1 points, respectively, p<0.001). Similarly, the 6MWD improved significantly more in the treatment group than in the control group (mean, 59.6 meters and 1.5 meters, respectively, p=0.004.).
Limitations of this study include a relatively small sample size for a common condition, relatively short intervention period, and lack of blinding; some of the positive findings on the subjective patient-reported outcomes may be due at least in part to a placebo effect. Also, the source of study funding in the Abraham et al study was not reported, and nearly all coauthors had financial links to the manufacturer. Additional RCTs with larger sample sizes and longer follow-up are needed to confirm these positive findings. Moreover, baroreflex stimulation devices are not cleared or approved by the U.S. Food and Drug Administration for use in the United States.
2017 Update
A literature search conducted using the MEDLINE database through August 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A single-arm study using the second-generation Neo device to treat uncontrolled hypertension was published in 2016 by Wallbach et al (Wallback, 2016). The study reported on 44 patients with resistant hypertension, defined as an office BP at least 140 mm Hg or 130 mm Hg for patients with chronic kidney disease and proteinuria, despite treatment with at least 3 antihypertensive medications including a diuretic. Mean baseline office BP was 171/91 mm Hg. After 6 months of baroreflex activation therapy, mean office BP decreased to 151±26 mm Hg over 82±17 mm Hg (pre to post, p<0.001). At 6 months, the mean number of BP medications used per patient decreased from 6.5±1.5 at baseline to 6.0±1.8 (p<0.03). One procedure-related major adverse event occurred, a contralateral stroke. Ten (23%) of the 44 patients experienced a minor procedure-related complication. The most common minor adverse events were disturbance of wound healing (n=5 [11%]) and postoperative hematoma (n=4 [9%]). One patient had revision surgery but explantation was not needed.
One RCT, discussed in an earlier update, has evaluated baroreflex stimulation for the treatment of heart failure Abraham, 2015). Twelve-month results for 101 (69%) of 146 patients were reported by Weaver et al (2016). No additional system- or procedure-related MANCE occurred between 6 and 12 months. Moreover, outcomes for NYHA functional class improvement, QOL score, and 6MWD were all significantly better in the treatment group than in the control group at 12 months. This analysis had a substantial amount of missing data. Overall, the limitations of this RCT included a relatively small sample size for a common condition, relatively short intervention period, and lack of blinding; some of the positive findings on the subjective patient-reported outcomes may be due at least in part to a placebo effect. Additional RCTs with larger sample sizes and longer follow-up are needed to confirm these positive findings.
National Institute for Health and Care Excellence
In 2015, National Institute for Health and Care Excellence issued guidance that stated: “Current evidence on the safety and efficacy of implanting a baroreceptor stimulation device for resistant hypertension is inadequate. Therefore, this procedure should only be used in the context of research” (NICE, 2015).
Summary of Evidence
For individuals who have treatment-resistant hypertension who receive baroreflex stimulation therapy, the evidence includes 1 randomized controlled trial (RCT) and several small uncontrolled studies. Relevant outcomes are overall survival, functional outcomes, quality of life, hospitalizations, medication use, and treatment-resistant morbidity. The uncontrolled studies have reported short-term reductions in blood pressure in patients treated with baroreflex stimulation devices, as well as adverse events such as infection, hypoglossal nerve injury, and wound complications. The RCT comparing baroreflex stimulation with continued medical management met some of the efficacy end points but not others and 2 of its 3 predefined safety end points. Additional RCTs are needed to permit conclusions on the efficacy and safety. In addition, baroreflex stimulation currently has a very narrow FDA approval (ie, for patients who previously participated in a pivotal trial) and broader approval or clearance is needed for wider application. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have treatment-resistant heart failure who receive baroreflex stimulation therapy, the evidence includes 1 RCT. Relevant outcomes are overall survival, functional outcomes, quality of life, hospitalizations, medication use, and treatment-resistant morbidity. The RCT met all 3 efficacy end points but had methodologic limitations, including lack of blinding, a relatively small sample size for a common condition and a relatively short intervention period. A second, larger, RCT designed to assess the effects of the intervention on mortality, safety, functional, and quality of life outcomes, is underway. In addition, the 1 baroreflex stimulation device with humanitarian device exemption approval currently has only a very narrow FDA approval (ie, for patients who previously participated in a pivotal trial) and broader approval or clearance is needed for wider application. The evidence is insufficient to determine the effect of the
technology on health outcomes.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2018. No new literature was identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2020, Cai et al published a meta-analysis evaluating the efficacy of baroreflex activation therapy for heart failure (Cai, 2020). The meta-analysis included 4 RCTs and concluded that baroreflex activation therapy significantly improves quality of life score, 6-minute hall walk distance, New York Heart Association (NYHA) class, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and duration of hospitalization compared to control. However, the 4 RCTs included in the analysis all represented the same patient population from the Hope for Heart Failure (HOPE4HF) study (NCT01471860 and NCT01720160) and did not account for the overlapping population between studies. Therefore, this meta-analysis likely overestimated the true effect of baroreflex activation therapy.
In 2019, the Barostim Neo System was the first device to receive premarket approval through the U.S. Food and Drug Administration's (FDA's) Expedited Access Pathway (FDA, 2019). The safety and effectiveness data reviewed by the FDA was reported in the Barostim Neo-Baroreflex Activation Therapy for Heart Failure (BeAT-HF) trial (Zile, 2018; Zile, 2020).
BeAT-HF examined the safety and effectiveness of baroreflex activation therapy in heart failure patients with reduced ejection fraction using an Expedited and Extended Phase design. In the Expedited Phase, baroreflex activation therapy plus guideline-directed medical therapy was compared at 6 months post-implant to guideline-directed medical therapy alone using 3 intermediate end points: 6-minute hall walk distance , Minnesota Living with Heart Failure Questionnaire, and NT-proBNP. The rate of heart failure morbidity and cardiovascular mortality was compared between the arms to evaluate early trending using predictive probability modeling.
In the Expedited Phase, investigators randomized 264 intended use patients. The primary safety endpoint was major adverse neurological and cardiovascular event free rate , which was only measured in the baroreflex group ; the lower bound of the one-sided 95% CI of the event-free rate had to be > 85%. Results analysts were blinded to arm assignment. At 6 months, the major adverse neurological and cardiovascular event -free rate was 96.8% (121 of 125 patients), and the one-sided 95% lower bound was 92.8% (p<.001). The FDA concluded from these results that the system was safe for the intended use population, and all effectiveness endpoints showed a statistically significant benefit for baroreflex activation therapy plus guideline-directed medical therapy compared to guideline-directed medical therapy alone.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2022, the American Heart Association, American College of Cardiology, and multiple other organizations published a guideline on management of heart failure (AHA/ACC/HFSA Guideline for the Management of Heart Failure, 2022). The guideline states that baroreceptor stimulation has produced mixed results and data regarding mortality and hospitalization are lacking.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Coats et al conducted a patient-level meta-analysis (N=554) comparing patients who received baroreceptor activation therapy in addition to guideline-directed medical therapy or guideline-directed medical therapy alone (Coats, 2022). Patients included in the analysis were enrolled in 1 of 2 RCTs (HOPE4HF and Barostim Neo-Baroreflex Activation Therapy for Heart Failure [BeAT-HF; both described below]). The studies were conducted between 2012 and 2018 in North American and European countries and enrolled patients with a left ventricular ejection fraction (LVEF) less than or equal to 35%. More than 80% of patients were male and all had NYHA Class III heart failure (or Class II with a recent history of Class III). Similar to the results of the individual trials, at 6 months, patients treated with baroreceptor activation therapy had improved 6-minute hall walk distance (48.5 meters; 95% confidence interval [CI], 32.7 to 64.2). More patients had improvements in NYHA in the baroreceptor activation therapy group with a 3.4 higher odds of improving at least 1 NYHA class compared to medical therapy alone. Quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) was also improved with the addition of baroreceptor activation therapy (-13.4 points; 95% CI, -17.1 to -9.6). This analysis is limited by the small number of RCTs and the open-label design of these trials.
BeAT-HF includes an extended phase in which the heart failure morbidity and cardiovascular mortality end point is based on an expected event rate of 0.4 events/patient/year in the guideline-directed medical therapy arm. This trial has preliminary results, but is not yet fully published (GlobeNewswire, 2023).
In 2022, the American Heart Association, American College of Cardiology, and multiple other organizations published a guideline on management of heart failure (Heidenreich, 2022). The guideline states that baroreceptor stimulation has produced mixed results, and data regarding mortality and hospitalization are lacking.
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| References: |
Abraham WT, Zile MR, Weaver FA, et al.(2015) Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. Jun 2015;3(6):487-496. PMID 25982108 Acelajado MC, Calhoun DA.(2010) Resistant hypertension, secondary hypertension, and hypertensive crises: diagnostic evaluation and treatment. Cardiol Clin 2010; 28(4):639-54. AHA/ACC/HFSA Guideline for the Management of Heart Failure:(2022) A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. JACC. Published online April 1, 2022. https://doi.org/10.1016/j.jacc.2021.12.012 Bakris GL, Nadim MK, Haller H et al.(2012) Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens 2012; 6(2):152-8. Bisognano JD, Bakris G, Nadim Mk, et al.(2011) Baroreflex activation therapy lowers blood presure in patients with resistant hypertension results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Ccardiol. 2011 Aug 9;58(7):765-73. Cai G, Guo K, Zhang D, et al.(2020) The efficacy of baroreflex activation therapy for heart failure: A meta-analysis of randomized controlled trials. Medicine (Baltimore). Nov 06 2020; 99(45): e22951. PMID 33157936 Food and Drug Administration (FDA).(2019) Summary of Safety and Effectiveness Data (SSED). 16 Aug 2019; https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf. Accessed March 31, 2021. Food and Drug Administration.(2014) Humanitarian Device Exemption (HDE): Barostim Neo Legacy System. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=h130007. Accessed April 17, 2017. Food and Drug Administration.(2015) Letter: Expedited Access Pathway (EAP) Designation. 2015; http://www.cvrx.com/wp-content/uploads/2013/05/900108-001_Q150760_FDA-Grant-Letter-for-EAPDesignation-Request_26Jun15-1.pdf. Accessed April 17, 2017. Heusser K, Tank J, Engeli S et al.(2010) Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension 2010; 55(3):619-26. Hoppe UC, Brandt MC, Wachter R et al.(2012) Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens 2012; 6(4):270-6. National Institute for Clinical and Care Excellence (NICE).(2015) Implanting a baroreceptor stimulation device for resistant hypertension [IPG533]. 2015; https://www.nice.org.uk/guidance/ipg533. Accessed April 18, 2017. Sanchez L NM, et al.(2011) Baroreflex activation therapy sustanably lowers blood pressure in patients with resistant hypertension: Results from the Rheos Pivotal Trial. Paper presented at: American College of Cardiology Annual Meeting 4/5/11, 2011; New Orleans, LA. Scheffers IJ, Kroon AA, Schmidli J et al.(2010) Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol 2010; 56(15):1254-8. Sponsored by CRVx Inc. Barostim Hope for Heart Failure (HOPE4HF) Study (NCT01720160). Available online at: www.clinicaltrials.gov. Last accessed September, 2013. Sponsored by CRVx Inc. Barostim Neo System in the Treatment of Heart Failure (NCT01471860). Available online at: www.clinicaltrial.gov. Last accessed September, 2013. Sponsored by CRVx Inc. CVRx Barostim Hypertension Pivotal Trial (NCT01679132). Available online at: www.clinicaltrials.gov. Last accessed September, 2013. Tordoir JH, Scheffers I, Schmidli J et al.(2007) An implantable carotid sinus baroreflex activating system: surgical technique and short-term outcome from a multi-center feasibility trial for the treatment of resistant hypertension. Eur J Vasc Endovasc Surg 2007; 33(4):414-21. Wallbach M, Lehnig LY, Schroer C, et al.(2016) Effects of baroreflex activation therapy on ambulatory blood pressure in patients with resistant hypertension. Hypertension. Apr 2016;67(4):701-709. PMID 26902491 Weaver FA, Abraham WT, Little WC, et al.(2016) Surgical experience and long-term results of baroreflex activation therapy for heart failure with reduced ejection fraction. Semin Thorac Cardiovasc Surg. Summer 2016;28(2):320-328. PMID 28043438 www.clinicaltrials.gov.(2012) Barostim Neo System in the Treatment of Heart Failure. NCT01471860. Accessed 10/23/2012. www.clinicaltrials.gov.(2012) Barostim Neo System in the Treatment of Resistant Hypertension. NCT01471834. Accessed 10/23/2012. www.clinicaltrials.gov.(2012) Rheos® Diastolic Heart Failure. NCT00718939. Accessed 10/23/2012. Zile MR, Abraham WT, Lindenfeld J, et al.(2018) First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF. Am Heart J. Oct 2018; 204: 139-150. PMID 30118942 Zile MR, Lindenfeld J, Weaver FA, et al.(2020) Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. Jul 07 2020; 76(1): 1-13. PMID 32616150 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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