Latest Review Date: October 2023

Category: Surgery                                                                 

POLICY:

Radiofrequency ablation of the renal sympathetic nerves for the treatment of uncontrolled hypertension is considered not medically necessary.

DESCRIPTION OF PROCEDURE OR SERVICE:

Radiofrequency ablation (RFA) of the renal sympathetic nerves is thought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure is said to decrease sympathetic activation, decrease vasoconstriction, and decrease activation of the renin-angiotensin system. RFA of the renal sympathetic nerves may act as a nonpharmacologic treatment for hypertension and has been proposed as a treatment option for patients with uncontrolled hypertension despite the use of antihypertensive medications.

Uncontrolled Hypertension

Hypertension is a widely prevalent condition, which is estimated to affect approximately 30% of the population in the United States. It accounts for a high burden of morbidity related to strokes, ischemic heart disease, kidney disease, and peripheral arterial disease. 

An estimated 1 in 4 adults with hypertension have their hypertension under control, but the remaining 77% (93 million) remain uncontrolled. Uncontrolled hypertension is diagnosed when an individual's blood pressure remains above targeted levels when a patient either:

• is not using, or is unable to use treatments to control blood pressure; or
• when hypertension persists despite antihypertensive therapies.

The definition of uncontrolled hypertension is inclusive of resistant hypertension in which blood pressure remains above the targeted range despite the use of 3 or more antihypertensive medications, including a diuretic, with complementary mechanisms of action. There are a number of factors that may contribute to uncontrolled hypertension, including nonadherence to medications, excessive salt intake, inadequate doses of medications, excess alcohol intake, volume overload, drug-induced hypertension, and other forms of secondary hypertension. Also, sometimes it is necessary to address comorbid conditions, i.e., obstructive sleep apnea, to adequately control BP.

RF Denervation of the Renal Sympathetic Nerves

Increased sympathetic nervous system activity has been linked to essential hypertension. Surgical sympathectomy has been shown to be effective in reducing blood pressure but is limited by the adverse effects of surgery and was largely abandoned after effective medications for hypertension became available. The renal sympathetic nerves arise from the thoracic nerve roots and innervate the renal artery, the renal pelvis, and the renal parenchyma. Radiofrequency ablation (RFA) is thought to decrease both the afferent sympathetic signals from the kidney to the brain and the efferent signals from the brain to the kidney. This procedure decreases sympathetic activation, decrease in vasoconstriction, and a decrease activation of the renin-angiotensin system.

The procedure is performed percutaneously with access at the femoral artery. A flexible catheter is threaded into the renal artery and controlled energy source, most commonly low-power radiofrequency (RF) energy is delivered to the arterial walls where the renal sympathetic nerves are located. Once adequate RF energy has been delivered to ablate the sympathetic nerves, the catheter is removed.

KEY POINTS:

The most recent literature review was updated through August 25, 2023.

Summary of Evidence

For individuals who uncontrolled hypertension, despite the use of anti-hypertensive medications, who receive RFA of the renal sympathetic nerves, the evidence includes several RCTs, numerous systematic reviews of the RCTs, and a multinational registry study. Relevant outcomes are symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. The proof of principle SPYRAL HTN-OFF MED study found that multielectrode renal denervation was superior to sham in the absence of background antihypertensive medication therapy, with between-group differences of -4.0 mmHg for 24-h SBP and -6.6 for office SBP at 3 months. The unpowered SPYRAL HTN-ON MED study also found significant between-group differences of -7.4 mmHg for 24-h SBP and -6.8mmHg for office SBP at 6 months; however, results were only significant for the subgroup of patients non-adherent to medications. Long-term data from the SPYRAL HTN-ON MED study suggest that blood pressure reductions with multielectrode renal denervation are progressive and sustained over time. The SPYRAL HTN-ON MED Expansion study failed to meet its primary efficacy endpoint and found only 0.03 mmHg difference between renal denervation and sham control groups at 6 months follow-up. A significant reduction in office blood pressure was noted at 6 months (-4.1 mmHg). Confounding of these outcome estimates by unbalanced medication changes, missing 24-h SBP outcome data, and timing of antihypertensive medications related to 24-h SBP assessment may explain the discordant results between the pilot and expansion phases of this trial. Study interpretation is also complicated by short-term blinded follow-up and imputation of excluded crossover patient data. It is unclear which patients are most likely to derive benefit, and currently, there is no practical method to verify nerve destruction following ablation. Evidence from systematic reviews and meta-analyses are conflicting, but all available studies included evidence from both first and second-generation Symplicity catheters as well as multiple renal denervation methodologies such as ultrasound. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

American Heart Association et al

In 2015, the American Heart Association, American College of Cardiology, and American Society of Hypertension issued guidelines on the treatment of hypertension in patients with coronary artery disease. The guideline noted that the SYMPLICITY HTN-3 trial did not find a significant benefit from renal denervation and stated that additional RCTs are needed.

The American Heart Association, American College of Cardiology, and 9 additional specialty societies (2018) published joint guidelines on the prevention, detection, evaluation, and management of high blood pressure in adults. In discussing resistant hypertension, the guidelines indicated that studies using catheter ablation of renal sympathetic nerves “have not provided sufficient evidence to recommend the use of these devices.”

The American Heart Association (2018) published a Scientific Statement on the detection, evaluation, and management of resistant hypertension. The AHA Statement discussed the lack of benefit found in the Symplicity HTN-3 trial, as well as its methodological limitations. The AHA Statement also referred to the more recent positive data from the SPYRAL HTN-OFF MED trial, but noted that because the enrolled patients did not have resistant hypertension, "at best, this represents a proof-of-principle study demonstrating the role of the renal sympathetic nervous system in hypertension." The AHA Statement concluded that "the role of device-based sympatholytic treatments, as with renal denervation and baroreceptor stimulation, awaits clarification."

Eighth Joint National Committee

In 2014, the Eighth Joint National Committee, which was appointed to provide recommendations about hypertension treatment, published an evidence-based guideline for the management of hypertension in adults.  This guideline does not discuss the use of renal denervation.

European Society for Hypertension (ESH)

The ESH, with endorsement by the European Renal Association and the International Society of Hypertension, issued guidance on the management of arterial hypertension in 2023. The following recommendations were issued concerning renal denervation:

• Renal denervation can be considered as a treatment option in patients with an eGFR of > 40 ml/min/1.73m2 who have uncontrolled blood pressure despite the use of anti-hypertensive drug combination therapy or if drug treatment elicits serious side effects. (Class of Recommendation: II, Level of Evidence: B)
• Renal denervation can be considered as an additional treatment option in patients with resistant hypertension if eGFR is > 40 ml/min/1.73m2 . (Class of Recommendation: II, Level of Evidence: B)
• Selection of patients to whom renal denervation is offered should be done in a shared decision-making process after objective and complete patient information is collected. (Class of Recommendation: I, Level of Evidence: C)
• Renal denervation should only be performed in experienced specialized centers to guarantee appropriate selection of eligible patients and completeness of the denervation procedure. (Class of Recommendation: I, Level of Evidence: C)

A class of recommendation I indicate a general consensus that the measure is useful, and a class II recommendation reflects that there is no general consensus and that only doubtful evidence exists. An 'A' level of evidence indicates that RCTs or metaanalyses with cardiovascular disease outcomes are available for this recommendation, a level 'B' suggests RCTs with surrogate measures, observational studies with cardiovascular disease outcomes or meta-analyses are available, and a C recommendation reflects either expert opinion or only observational or lower quality experimental evidence.

ESH recommendations did not discuss the specific use of radiofrequency renal denervation and included evidence from other modalities, such as ultrasound, in their evidence appraisal.

National Institute for Health and Care Excellence

In 2023, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of percutaneous transluminal radiofrequency sympathetic denervation of the renal artery for resistant hypertension, recommending that the procedure should only be used with special arrangements for clinical governance, consent, and audit or research due to limited evidence.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Renal artery denervation, Radiofrequency ablation of the renal sympathetic nerves, EnligHTN, One-Shot Renal Denervation System™ Simplicity, Thermocouple Catheter™, V2 renal denervation system, Vessix™

APPROVED BY GOVERNING BODIES:

No radiofrequency ablation (RFA) devices have been approved for ablation of the renal sympathetic nerves as a treatment for hypertension. There are several devices that have been developed for this purpose and are in various stages of application for U.S. Food and Drug Administration (FDA) approval.

• The Symplicity Spyral™ Renal Denervation System (Medtronic) is a multielectrode RFA catheter system designed to deliver 4-quadrant ablations. On August 23, 2023 the FDA Advisory Committee for Circulatory System Devices voted that the Symplicity Spyral system met its safety endpoint as well as its efficacy endpoint, but after a tied vote in which the chairperson cast the final vote, the committee determined that the device did not achieve a positive balance of benefits and harms.
• The EnligHTN™ Multi-Electrode Renal Denervation System (St. Jude Medical, Plymouth, MN) is an RFA catheter using a 4-point multi-ablation basket design.  In January 2014, the EnligHTN™ Renal Guiding Catheter received clearance for marketing through the 510(k) process based on substantial equivalence to predicate devices (product code: DQY) for the following indication: percutaneous use through an introducer sheath to facilitate a pathway to introduce interventional and diagnostic devices into the renal arterial vasculature.
• The Vessix™ Renal Denervation System (Boston Scientific Marlborough, MA, formerly the V2 renal denervation system, Vessix Vascular) is a combination of a RF balloon catheter and bipolar RF generator technologies, intended to permit a lower voltage intervention.

Other RFA catheters (e.g., Thermocouple Catheter™ [Biosense Webster]) used for other types of ablation procedures (e.g., cardiac electrophysiology procedures) have been used off-label for RFA of the renal arteries.

In 2020, the FDA granted breakthrough therapy designation to 2 renal artery denervation systems - SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System and Recor's Paradise Renal Denervation System - for treatment of patients with persistently elevated blood pressure. However, ultrasound-based renal denervation systems are outside of the scope of this evidence review.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

REFERENCES:

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37. Kandzari DE, Bhatt DL, Sobotka PA et al. Catheter-based renal denervation for resistant hypertension: rationale and design of the SYMPLICITY HTN-3 trial. Clin Cardiol 2012; 35(9):528-535.
38. Kandzari DE, Bohm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. Jun 092018; 391(10137): 2346-2355.
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53. Miroslawska A, Solbu M, Skjolsvik E, et al. Renal sympathetic denervation: effect on ambulatory blood pressure and blood pressure variability in patients with treatment-resistant hypertension. The ReShape CV-risk study. J Hum Hypertens. Mar 2016; 30(3):153-157. 
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POLICY HISTORY:

Medical Policy Panel, August 2012

Medical Policy Group, August 2012 (4): New policy

Medical Policy Administration Committee, August 2012

Available for comment September 18 through November 1, 2012

Medical Policy Panel, September 2013

Medical Policy Group, September 2013 (4): Updated Key Points, Key Words, Approved Governing Bodies and References. No changes to the policy statement at this time.

Medical Policy Group, December 2013 (1): 2014 Coding Update: added new codes 0338T and 0339T, effective 01/01/2014

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (3): 2014 Updates to Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Panel, September 2015

Medical Policy Group, September 2015 (4): Updates to Description, Key Points, Key Words, Coding and References; no change in policy statement.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (4):  Updates to Description, Key Points, and References; no change in policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (4): Updates to Key Points.  No change to policy statement.

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (4): Updates to Key Points, Governing Bodies, Practice Guidelines and References.

Medical Policy Panel, September 2019Medical Policy Group, September 2019 (4): Updates to References. No change to policy statement.

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (4):  Updates to Key Points, Approved by Governing Bodies, Previous Coding section, and References.  Removed 64999 from Previous Coding section.

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (4): Updates to Key Points, Approved by Governing Bodies, and References.  Policy statement updated to remove “investigational”. No change to policy intent. References removed.

Medical Policy Panel, October 2022

Medical Policy Group, November 2022 (4): Updates to Title, Description, Key Points, Approved by Governing Bodies, and References.  Title and Policy statement updated to include “uncontrolled” hypertension. No change in policy intent.

Medical Policy Panel, October 2023

Medical Policy Group, October 2023 (4): Updates to Policy, Description, Key Points, Approved by Governing Bodies, Benefit Application, and References.  Removed “resistant” from policy statement. Policy intent unchanged, resistant is being encompassed under uncontrolled.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.