Medical Policy

 

Subject: Carotid Sinus Baroreceptor Stimulation Devices
Document #: SURG.00124 Publish Date:    06/06/2018
Status: Reviewed Last Review Date:    05/03/2018

Description/Scope

This document addresses the insertion and use of a carotid sinus baroreflex activation device which has been proposed for the treatment of drug-resistant hypertension.

Position Statement

Investigational and Not Medically Necessary:

The use of a carotid sinus baroreflex activation device is considered investigational and not medically necessary for all indications.

Rationale

Drug-resistant hypertension is diagnosed when blood pressure remains above goal despite the use of three concurrent antihypertensive agents of different classes. Of the three agents, one should be a diuretic and all of them should be prescribed at their optimal dose amounts. The number of individuals with drug-resistant hypertension is unknown but is estimated to be 20% to 30% of clinical trial participants with the prevalence expected to increase due to the aging of the population. Drug-resistant hypertension is not the same as uncontrolled hypertension. Uncontrolled hypertension is a lack of blood pressure control due to poor adherence or an insufficient treatment regimen.

New treatment options are being explored to treat drug-resistant hypertension. One such approach is the electrical activation of the carotid sinus baroreflex. This procedure was first introduced in the 1960s and 1970s for the treatment of drug-resistant hypertension and refractory angina pectoris. It consisted of chronically stimulating the carotid sinus nerves using implanted nerve electrodes with an implantable radiofrequency controlled receiver. At that time, this approach was not adopted as a viable treatment option for hypertension due to the development of new drugs used in the treatment of hypertension and the technical limitations of implantable medical devices during that time period. Newer devices are now being developed, first-generation and second-generation devices, which bilaterally activate the carotid sinus baroreflex by electrically stimulating the carotid sinus wall. A surgical implant procedure is used to place the device under the skin near the clavicle. The electrodes are placed on the carotid arteries and the leads run under the skin and are connected to a battery powered implanted impulse generator device. Blood pressure lowering is felt to be mediated through sympathetic inhibition (Heusser, 2010).

Tordoir and colleagues (2007) report on the preliminary analysis of 17 participants with drug-resistant hypertension. During this study the participants’ antihypertensive regimens remained the same for the first 4 months. The participants were analyzed at the 4-month follow-up (3 months following the continued electrical baroreflex activation therapy). Investigators hypothesized that there would be a reduction of at least 10 mm Hg of systolic blood pressure at the 4-month follow-up. Adverse events related to the device included intraoperative bradycardia and pain. Adverse events related to the procedure included infection, hypoglossal nerve injury, intraoperative bradycardia, pain, wound complication, extravascular tissue stimulation, anesthesia complications, and injury to local tissue. One-month systolic blood pressure (prior to device activation) ranged from 144-184 and diastolic blood pressure ranged from 84-105. At 4 months, systolic blood pressure ranged from 143-165 and diastolic blood pressure ranged from 81-95. The investigators also reported that “the degree of hemodynamic change was directly related to the amplitude of stimulation.” The authors concluded that the preliminary data suggest reasonable safety of the implant and sustained hemodynamic response up to 4 months. However, the authors further noted that “long-term therapeutic results of this ongoing safety and efficacy trial are needed as the basis for a multi-center, controlled trial of the device for this indication” (Tordoir, 2007).

Scheffers and colleagues (2010) reported on the safety and efficacy of an implantable device for use in drug-resistant hypertension. The Device Based Therapy in Hypertension Trial (DEBuT-HT) studied 45 subjects over a 3-month time period for the safety and efficacy of the carotid sinus baroreflex activation device. Blood pressure of the participants was greater than or equal to 160/90 despite the use of at least three antihypertensive medications (one of which was a diuretic). All participants were deemed compliant with their medication regimen and the regimen was kept constant for 2 months prior to entering the study. The study baseline time point was 1 month following insertion of the device which is when the device was activated. Participants were followed monthly for the first 3 months and annually thereafter. Of the 45 participants who received the implanted device, the first 3 subjects were excluded from the analysis per protocol of the study. Four subjects dropped out of the study and 1 missed visits resulting in 37 participants available for evaluation. At the 3-month office evaluation, systolic blood pressure decreased by 21 mm Hg and diastolic blood pressure decreased by 12 mm Hg. Twenty-six participants were evaluated at 1 year. At that time, systolic blood pressure decreased by 30 mm Hg and diastolic blood pressure decreased by 20 mm Hg. At the 2-year visit, only 17 participants were available for evaluation. Systolic blood pressure decreased by 33 mm Hg and diastolic blood pressure decreased by 22 mm Hg.

Bisognano (2011) reported the results of the Rheos® Pivotal Trial which was a randomized, double-blind, placebo-controlled study to measure safety and efficacy of a baroreflex activation device for individuals with drug-resistant hypertension. A total of 265 individuals met enrollment criteria which consisted of systolic blood pressure ≥ 160 mm Hg with diastolic blood pressure ≥ 80 mm Hg. At least 1 month of maximally tolerated therapy with at least three antihypertensive medications (including a diuretic) was completed before the next blood pressure reading. After 1 month of drug therapy, participants were randomized into 2 groups; Group A consisted of 181 individuals who received immediate implant of a baroreflex activation device. Group B was 84 individuals who received the implant of a baroreflex activation device following a 6-month deferment. Primary endpoints were: 1) acute efficacy; 2) sustained efficacy; 3) procedure safety; 4) baroreflex activation therapy safety; and 5) device safety. Secondary endpoints included mean change of systolic blood pressure and a comparison of immediate versus deferred efficacy. In order to maintain blinding, statistical analyses were completed by a data monitoring committee. At the 6-month analysis, 95 participants had not yet completed their 6-month visit and the committee advised that it was unlikely the trial would attain significance for the acute efficacy analysis. The trial also failed to meet the endpoint for procedure safety with an event-free rate of 74.8% which was less than the pre-specified criterion of 82%. The majority of events were related to the carotid sinus lead placement, but also included general surgical complications, respiratory complaints, and wound complications. The mean change in systolic blood pressure decreased by 16 ± 29 mm Hg at 6 months for Group A and 9 ± 29 mm Hg for Group B. At 12 months (in which Group A had received 12 months of baroreflex activation therapy) the mean systolic blood pressure decrease was 25 ± 32 mm Hg, Group B had received 6 months of baroreflex activation therapy at the 12-month visit and their mean systolic blood pressure decrease was 25 ± 31 mm Hg.

Bakris and colleagues (2012) reported on the long-term follow-up of the Rheos Pivotal Trial. Several individuals from the Rheos trial participated in a single-arm, open-label, non-randomized continuation study to assess safety and efficacy of baroreflex activation therapy at 12 months. There were 276 participants from the original Rheos trial that remained in the continuation trial. These participants were measured for clinically significant response as measured by a systolic blood pressure less than or equal to 140 mm Hg (less than 130 mm Hg in diabetics or those with renal disease) or if systolic blood pressure dropped by 20 mm Hg or more from device activation. A total of 244 of the 276 participants were classified as clinically significant responders. The status of 32 participants is as yet undetermined. At month 12, systolic blood pressure dropped more than 30 mm Hg from the preimplantation to the low 140s with an average systolic blood pressure of 143 mm Hg. There have been 13 deaths throughout the course of the trial, none of which were judged to be related to either the procedure or the device. The longer term follow-up shows great potential of baroreflex activation therapy in the treatment of resistant hypertension. However, there are limitations including dilution of statistical power by the high observed variability in blood pressure measurements and the hampering by baseline levels of and adjustments to aggressive medical therapy. Future studies with stable background therapies and fewer confounding therapies are reasonable and the strength of conclusions is limited by the exclusion of the participants deemed to be nonresponders.

A second generation device has now been developed. Hoppe and colleagues (2012) reports on 30 participants with resistant hypertension with a systolic blood pressure greater than or equal to 140 mm Hg. The primary efficacy objective was a reduction in systolic blood pressure through 6 months of baroreflex activation therapy. The primary safety objective was description of all complications though the 6 months of therapy. Baroreflex activation therapy was initiated 2 weeks after being implanted. One participant missed their 6-month visit and data was collected for 29 participants at 6 months. Preimplant baseline blood pressures were 171.1 ± 20.2/99.5 ± 13.9 mm Hg. Postimplant systolic blood pressure was reduced by an average of 26.1 ± 3.3 mm Hg and remained stable at the 6-month visit. Complications included a self-inflicted wound complication, a pulse generator pocket hematoma, and discomfort in the pulse generator pocket which prompted the request to have the device repositioned. Larger scale, randomized controlled trials with long-term follow-up are necessary to evaluate efficacy and safety of baroreflex activation therapy.

In a 2016 prospective trial by Wallbach and colleagues, the authors evaluated the impact of the second generation baroreflex activation therapy device on 24-hour ambulatory blood pressure in those individuals with hypertension refractory to therapy. Study inclusion criteria included office systolic blood pressure greater than or equal to 140 mm Hg or greater than or equal to 130 mm Hg for those individuals with chronic kidney disease and proteinuria, therapy of at least three antihypertensive medications including a diuretic, and age greater than or equal to 18 years. All study participants had been treated for hypertension for at least 1 year and baseline medication was unchanged for at least 3 months prior to implantation of the device. A total of 51 participants were included in the study, however 7 participants were excluded from analysis due to missing or insufficient follow-up ambulatory blood pressure data. All participants had ambulatory blood pressure performed prior to implantation of the baroreflex activation therapy device and at 6 months after initiation of the therapy device. Adverse events included 1 participant with contralateral stroke and 10 participants with procedure-related complications including disturbance of wound healing, post-operative hematoma, hematoma of the vocal cord, repositioning and revision surgeries. There was a drop in systolic blood pressure of greater than or equal to 10 mm Hg in office or greater than or equal to 5 mm Hg in ambulatory blood pressure in 34 of 44 participants. The withdrawal of at least one antihypertensive drug was realizable in 16 participants and 10 participants had antihypertensive treatment increased. This study has several limitations which include a small sample size and lack of a control group which according to the authors would be “crucial in defining real outcomes.” It is also noted that the study inclusion criteria for blood pressure was readings taken during the office and not ambulatory readings. While this approach holds promise for those individuals with drug-resistant hypertension, further clinical trials are necessary to establish the safety and durable benefit of the device. 

In 2014, the Barostim neo® Legacy System (CVRx, Inc., Minneapolis, MN) received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA). The device is indicated for use in individuals with resistant hypertension who had bilateral implantation of the Rheos® carotid sinus leads which have been discontinued and are considered obsolete and were determined responders in the Rheos pivotal clinical study. The HDE approval process is applicable to devices intended to benefit individuals in the treatment or diagnosis of conditions or diseases that affect fewer than 4000 individuals in the U.S. per year. An HDE application is not required to submit the results of scientifically valid clinical investigations demonstrating the effectiveness of the device for its intended use. However, the application must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable health benefit outweighs the risks from its use.

Background/Overview

Blood pressure is the force of blood against the walls of arteries. It is measured by two numbers: the systolic pressure (when the heart beats) over the diastolic pressure (when the heart relaxes between beats). The numbers are written or expressed with the systolic number over the diastolic number. When blood pressure stays elevated over time it is considered to be high blood pressure. Blood pressure is considered to be hypertensive (higher than normal) when the systolic number is greater than 140 mm Hg and/or the diastolic number is greater than 90 mm Hg. The American Heart Association (AHA) reports that 76.4 million adults in the United States have been diagnosed with hypertension. Many individuals with hypertension take anti-hypertensive medications to control their blood pressure. Some individuals with hypertension are resistant to the medication. For those who have drug-resistant hypertension other treatment options are being explored; in particular, electrical stimulation of the carotid sinus baroreceptors.

The carotid sinus is an enlarged area in the neck at the point of bifurcation of the carotid artery which contains baroreceptors (pressure receptors). When the baroreceptors are stimulated this causes slowing of the heart rate, vasodilation (widening of the blood vessel) and a decrease in blood pressure.

Definitions

Hypertension: The term used to describe high blood pressure.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

0266T

Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)

0267T

Implantation or replacement of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed)

0268T

Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed)

0269T

Revision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed)

0270T

Revision or removal of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed)

0271T

Revision or removal of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed)

0272T

Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day);

0273T

Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (eg, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming

 

 

ICD-10 Procedure

 

03HK0MZ

Insertion of stimulator lead into right internal carotid artery, open approach

03HK3MZ

Insertion of stimulator lead into right internal carotid artery, percutaneous approach

03HK4MZ

Insertion of stimulator lead into right internal carotid artery, percutaneous endoscopic approach

03HL0MZ

Insertion of stimulator lead into left internal carotid artery, open approach

03HL3MZ

Insertion of stimulator lead into left internal carotid artery, percutaneous approach

03HL4MZ

Insertion of stimulator lead into left internal carotid artery, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Bakris GL, Nadim MK, Haller H, et al. 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):152-158.
  2. Bisognano JD, Bakris G, Nadim MK, et al. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled Rheos pivotal trial. J Am Coll Cardiol. 2011; 58(7):765-773.
  3. Heusser K, Tank J, Engeli S, et al. Carotid baroreceptor stimulation, sympathetic activity, baroreflex function, and blood pressure in hypertensive patients. Hypertension. 2010; 55(3):619-626.
  4. Hoppe UC, Brandt MC, Wachter R, et al. 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):270-276.
  5. Illig KA, Levy M, Sanchez L, et al. An implantable carotid sinus stimulator for drug-resistant hypertension: surgical technique and short-term outcome from the multicenter phase II Rheos feasibility trial. J Vasc Surg. 2006; 44(6):1213-1218.
  6. Joshi N, Taylor J, Bisognano JD. Implantable device therapy for the treatment of resistant hypertension. J Cardiovasc Transl Res. 2009; 2(2):150-153.
  7. Lovett EG, Schafer J, Kaufman CL. Chronic baroreflex activation by the Rheos system: an overview of results from European and North American feasibility studies. Conf Proc IEEE Eng Med Biol Soc. 2009; 2009:4626-4630.
  8. Scheffers IJ, Kroon AA, Schmidli J, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010; 56(15):1254-1258.
  9. Tordoir J, Scheffers I, Schmidli J, et al. 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):414-421.
  10. Wallbach M, Lehnig LY, Schroer C, et al. Effects of baroreflex activation therapy on ambulatory blood pressure in patients with resistant hypertension. Hypertension. 2016; 67(4):701-709.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Heart Association (AHA). Resistant hypertension: diagnosis, evaluation, and treatment: A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension 2008; 51(6):1403-1419. Available at: http://hyper.ahajournals.org/cgi/reprint/HYPERTENSIONAHA.108.189141. Accessed on April 12, 2018.
  2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness: Barostim neo® Legacy System. Humanitarian Device Exemption No. H130007. Rockville, MD: December 12, 2014. Accessible at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm. Accessed on April 12, 2018.
Websites for Additional Information
  1. American Heart Association. http://www.heart.org/HEARTORG/. Accessed on April 12, 2018.
Index

Barostim neo System
Hypertension
Rheos System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

05/03/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated References section.

Reviewed

05/04/2017

MPTAC review. Updated Rationale and References sections.

Reviewed

05/05/2016

MPTAC review. Removed ICD-9 codes from Coding section.

Reviewed

05/07/2015

MPTAC review. Updated Rationale and References.

Reviewed

05/15/2014

MPTAC review. No change to Position Statement.

Reviewed

05/09/2013

MPTAC review. Updated Rationale, Background/Overview and References.

Reviewed

05/10/2012

MPTAC review. Title change to “Carotid Sinus Baroreceptor Stimulation Devices”. Updated Description/Scope, Rationale, References, and Index.

New

05/19/2011

MPTAC review. Initial document development.