mp-503
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Radiofrequency Ablation of the Renal Sympathetic Nerves as a Treatment for Resistant Hypertension

Policy Number: MP-503

 

Latest Review Date: September 2021

Category: Surgery                                                                 

POLICY:

Radiofrequency ablation of the renal sympathetic nerves for the treatment of resistant 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 resistant hypertension.

Resistant 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. Resistant hypertension is defined as elevated blood pressure (BP) despite treatment with at least three antihypertensive agents at optimal doses. Resistant hypertension is also a relatively common condition, given the large number of individuals with hypertension. In large clinical trials of hypertension treatment, up to 20 to 30% of participants meet the definition for resistant hypertension, and in tertiary care hypertension clinics, the prevalence has been estimated to be 11 to 18%. Resistant hypertension is associated with a higher risk for adverse outcomes such as stroke, myocardial infarction (MI), heart failure, and kidney failure.

There are a number of factors that may contribute to uncontrolled hypertension, and these should be considered and addressed in all patients with hypertension before labeling a patient resistant. These include 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.

Treatment

Treatment for resistant hypertension is mainly intensified drug therapy, sometimes with the use of non-traditional antihypertensive medications such as spironolactone and/or minoxidil. However, control of resistant hypertension with additional medications is often challenging and can lead to high costs and frequent adverse effects of treatment. As a result, there is a large unmet need for additional treatments that can control resistant hypertension. Non-pharmacologic interventions for resistant hypertension include modulation of the baroreflex receptor, and/or radiofrequency (RF) denervation of the renal nerves.

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 July 23, 2021.

Summary of Evidence

For individuals who have hypertension resistant to standard medical management who receive RFA of the renal sympathetic nerves, the evidence includes numerous RCTs, numerous systematic reviews of the RCTs, as well as multiple nonrandomized comparative studies and case series. Relevant outcomes are symptoms, change in disease status, morbid events, medication use, and treatment-related morbidity. The largest trial, the Symplicity HTN-3 trial, used a sham-controlled design to reduce the likelihood of placebo effect and demonstrated no significant differences between renal denervation and sham control patients in office-based or ambulatory blood pressure at 6-month follow-up. The Symplicity HTN-3 results were in contrast to other studies not using a sham control design, including Symplicity HTN-2 and the Renal Denervation for Hypertension (DENERHTN) trial, which reported efficacy in reducing blood pressure over a 6-month period compared with a control group. However, results from Symplicity HTN-3 have been supported by a number of subsequent smaller sham controlled trials. Meta-analyses of the RCTs have also reported inconsistent findings, with most analyses showing no significant benefit in blood pressure measurements following RFA. Single-arm studies with overlapping populations have reported improvements in blood pressure and related physiologic parameters, such as echocardiographic measures of left ventricular hypertrophy, that appear to be durable up to 24 months of follow-up. The strongest evidence comes from sham-controlled trials, the largest of which found no significant benefits with renal denervation. 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.

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™ Renal Denervation System (Medtronic, Minneapolis, MN). In April 2018, FDA approved an investigational device exemption pivotal trial, SPYRAL HTN. The trial is randomized and sham-controlled and is designed to evaluate the RFA device as an alternative to exercise or lifestyle modification in patients with uncontrolled hypertension not treated with medication. Bohm et al (2020) has already published the 3-month results. The trial remains ongoing, however, with planned follow-up for 3 years for evaluation of long-term efficacy and safety. An additional randomized trial in patients with uncontrolled hypertension despite antihypertensive medication is ongoing
  • 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.
  • 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.

 

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.

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.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING: 

CPT Codes:

0338T

Transcatheter renal sympathetic denervation, percutaneous approach including arterial puncture, selective catheter placement(s) renal artery(ies), fluoroscopy, contrast injection(s), intraprocedural roadmapping and radiological supervision and interpretation, including pressure gradient measurements, flush aortogram and diagnostic renal angiography when performed; unilateral

0339T

Transcatheter renal sympathetic denervation, percutaneous approach including arterial puncture, selective catheter placement(s) renal artery(ies), fluoroscopy, contrast injection(s), intraprocedural roadmapping and radiological supervision and interpretation, including pressure gradient measurements, flush aortogram and diagnostic renal angiography when performed; bilateral

 

REFERENCES:

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  30. Hering D, Mahfoud F, Walton AS et al. Renal denervation in moderate to severe CKD. J Am Soc Nephrol 2012; 23(7):1250-7.
  31. Hering D, Marusic P, Walton AS, et al. Sustained sympathetic and blood pressure reduction 1 year after renal denervation in patients with resistant hypertension. Hypertension. Jul 2014; 64(1):118-124.
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  34. Jin Y, Jacobs L, Baelen M, et al. Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial. Blood Press. Jun 2014; 23(3):138-146.
  35. Kaiser L, Beister T, Wiese A, et al. Results of the ALSTER BP real-world registry on renal denervation employing the Symplicity system. EuroIntervention. May 2014; 10(1):157-165.
  36. 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.
  37. Kario K, Bhatt DL, Brar S, et al. Effect of catheter-based renal denervation on morning and nocturnal blood pressure: insights from SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. Dec 2015; 66(6):1130-1137.
  38. Kario K, Ogawa H, Okumura K, et al. SYMPLICITY HTN-Japan - first randomized controlled trial of catheter- based renal denervation in Asian patients. Circ J. Apr 2015;79(6):1222-1229.
  39. Korovesis S, Giazitzoglou E, Pantos I, et al. Renal denervation for resistant hypertension: acute results and long-term follow-up. Hellenic J Cardiol. May-Jun 2014; 55(3):211-216.
  40. Krum H, Schlaich M, Whitbourn R et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009; 373(9671):1275-81.
  41. Krum H, Schlaich MP, Sobotka PA, et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet. Feb 15 2014; 383(9917):622-629.
  42. Kwok CS, Loke YK, Pradhan S, et al. Renal denervation and blood pressure reduction in resistant hypertension: a systematic review and meta-analysis. Open Heart. 2014; 1(1):e000092.
  43. Lobo MD, de Belder MA, Cleveland T, et al. Joint UK societies' 2014 consensus statement on renal denervation for resistant hypertension. Heart. Jan 2015; 101(1):10-16.
  44. Lu D, Wang K, Liu Q, et al. Reductions of left ventricular mass and atrial size following renal denervation: a meta-analysis. Clin Res Cardiol. Aug 2016; 105(8):648-656.
  45. Mahfoud F, Cremers B, Janker J et al. Renal hemodynamics and renal function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension 2012; 60(2):419-424.
  46. Mahfoud F, Lüscher TF, Andersson B, et al. Expert consensus document from the European Society of Cardiology on catheter-based renal denervation. Eur Heart J. April 25, 2013 2013.
  47. Mahfoud F, Bakris G, Bhatt DL, et al. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur Heart J. Jan 7 2017;38(2):93-100.
  48. Mathiassen ON, Vase H, Bech JN, et al. Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial. J Hypertens. Aug 2016; 34(8):1639-1647.
  49. 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.
  50. Oliveras A, Armario P, Clara A, et al. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial. J Hypertens.
  51. Ott C, Mahfoud F, Schmid A et al. Renal denervation in moderate treatment resistant hypertension. J Am Coll Cardiol 2013.
  52. Pancholy SB, Shantha GP, Patel TM, et al. Meta-analysis of the effect of renal denervation on blood pressure and pulse pressure in patients with resistant systemic hypertension. Am J Cardiol. Sep 15 2014; 114(6):856-861.
  53. Pappaccogli M, Covella M, Berra E, et al. Effectiveness of renal denervation in resistant hypertension: a meta- analysis of 11 controlled studies. High Blood Press Cardiovasc Prev. May 11 2018.
  54. Pokushalov E, Romanov A, Corbucci G et al. A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol 2012; 60(13):1163-70.
  55. Prochnau D, Lucas N, Kuehnert H et al. Catheter-based renal denervation for drug-resistant hypertension by using a standard electrophysiology catheter. EuroIntervention 2012; 7(9):1077-80.
  56. Rosa J, Widimsky P, Tousek P, et al. Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study. Hypertension. Feb 2015; 65(2):407-413.
  57. Rosendorff C, Lackland DT, Allison M, et al. Treatment of hypertension in patients with coronary artery disease: a scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension. Circulation. May 12 2015; 131(19):e435-470.
  58. Schirmer SH, Sayed MM, Reil JC, et al. Atrial Remodeling Following Catheter-Based Renal Denervation Occurs in a Blood Pressure- and Heart Rate-Independent Manner. JACC Cardiovasc Interv. Jun 2015; 8(7):972-980.
  59. Schirmer SH, Sayed MM, Reil JC, et al. Improvements in left ventricular hypertrophy and diastolic function following renal denervation: effects beyond blood pressure and heart rate reduction. J Am Coll Cardiol. May 13 2014; 63(18):1916-1923.
  60. Schneider S, Promny D, Sinnecker D, et al. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. Nov 2015; 30(11):1928-1936.
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  62. Shantha GP, Pancholy SB. Effect of renal sympathetic denervation on apnea-hypopnea index in patients with obstructive sleep apnea: a systematic review and meta-analysis. Sleep Breath. May 17 2014.
  63. Sun D, Li C, Li M, et al. Renal denervation vs pharmacotherapy for resistant hypertension: a meta-analysis. J Clin Hypertens (Greenwich).
  64. Symplicity HTN-1 Investigators. Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension 2011; 57(5):911-7.
  65. Ukena C, Mahfoud F, Kindermann I et al. Cardiorespiratory response to exercise after renal sympathetic denervation in patients with resistant hypertension. J Am Coll Cardiol 2011; 58(11):1176-82.
  66. Ukena C, Mahfoud F, Spies A, et al. Effects of renal sympathetic denervation on heart rate and atrioventricular conduction in patients with resistant hypertension. Int J Cardiol. Sep 10 2013; 167(6):2846-2851.
  67. Verheye S, Ormiston J, Bergmann MW, et al. Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention. Feb 2015; 10(10):1221-1229.
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  72. Zhang X, Wu N, Yan W, et al. The effects of renal denervation on resistant hypertension patients: a meta-analysis. Blood Press Monit. Aug 2016; 21(4):206-214.
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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. The following references were removed:  Dong H, Jiang X, Liang T, et al. One-year outcomes of percutaneous renal denervation for the treatment of resistant hypertension: the first Chinese experience.;  Dores H, de Sousa Almeida M, de Araujo Goncalves P, et al. Renal denervation in patients with resistant hypertension: six-month results.; Ezzahti M, Moelker A, Friesema EC, et al. Blood pressure and neurohormonal responses to renal nerve ablation in treatment-resistant hypertension. ; Fengler K, Heinemann D, Okon T, et al. Renal denervation improves exercise blood pressure: insights from a randomized, sham-controlled trial. ;Id D, Kaltenbach B, Bertog SC, et al. Does the presence of accessory renal arteries affect the efficacy of renal denervation? ; Kiuchi MG, Maia GL, de Queiroz Carreira MA, et al. Effects of renal denervation with a standard irrigated cardiac ablation catheter on blood pressure and renal function in patients with chronic kidney disease and resistant hypertension. ; Lambert T, Gammer V, Nahler A, et al. Individual-patient visit-by-visit office and ambulatory blood pressure measurements over 24months in patients undergoing renal denervation for hypertension.; Lambert GW, Hering D, Esler MD et al. Health-related quality of life after renal denervation in patients with treatment-resistant hypertension.;  Mabin T, Sapoval M, Cabane V et al. First experience with endovascular ultrasound renal denervation for the treatment of resistant hypertension.;  Mahfoud F, Urban D, Teller D, et al. Effect of renal denervation on left ventricular mass and function in patients with resistant hypertension: data from a multi-centre cardiovascular magnetic resonance imaging trial.;  Ott C, Mahfoud F, Schmid A, et al. Improvement of albuminuria after renal denervation. ; Sievert H, Schofer J, Ormiston J, et al. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study.; Simonetti G, Spinelli A, Gandini R et al. Endovascular radiofrequency renal denervation in treating refractory arterial hypertension: a preliminary experience.; Tsioufis C, Dimitriadis K, Tsiachris D et al. Catheter-based renal sympathetic denervation for the treatment of resistant hypertension: first experience in Greece with significant ambulatory blood pressure reduction.

 

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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.