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MP 7.01.81 Nerve Graft in Association with Radical Prostatectomy

Medical Policy    
Section
Surgery
 
Original Policy Date
11/20/01
Last Review Status/Date
Reviewed with literature search/12:2012
Issue
12:2012
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


Description

Nerve grafting to replace cavernous nerves resected at the time of radical prostatectomy is proposed to reduce the risk of erectile dysfunction after this surgery. The sural nerve is most commonly used in grafting.

Erectile dysfunction is a common problem after radical prostatectomy. In particular, spontaneous erections are usually absent in patients whose extent of prostate cancer requires bilateral resection of the neurovascular bundles as part of the radical prostatectomy procedure. A variety of noninvasive treatments are available, including vacuum constriction devices and intracavernosal injection therapy. However, spontaneous erectile activity is preferred by patients. Studies have reported results from bilateral nerve grafts; there are also reports of unilateral grafts when only one neurovascular bundle has been resected.

There has been interest in sural nerve grafting to replace cavernous nerves resected at the time of prostatectomy. The sural nerve is considered expendable and has been used extensively in other nerve grafting procedures, such as brachial plexus and peripheral nerve injuries. As applied to prostatectomy, a portion of the sural nerve is harvested from one leg and then anastomosed to the divided ends of the cavernous nerve. Reports are also being published using other nerves, such as the genitofemoral nerve.


Policy

Unilateral or bilateral nerve graft is considered investigational in patients who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy.


Policy Guidelines

There are no specific CPT codes describing sural nerve grafting of the cavernous nerves; the CPT codes describing nerve grafts specifically identify the anatomic site and do not include the cavernous nerves. Therefore CPT code 64999 (unlisted procedure, nervous system) may be used to describe the nerve harvest and grafting component of the procedure. Alternatively, a nonspecific CPT code for nerve repair – 64910 or 64911 - may be used.


Benefit Application
BlueCard/National Account Issues

Nerve grafting in association with radical prostatectomy is a specialized procedure that may require out-of-network referral.

In some cases, the nerve-harvesting procedure may be performed by a plastic surgeon or a neurosurgeon; in other cases, a urologist may perform both the nerve-harvesting, graft, and radical prostatectomy.

Specific contractual exclusions regarding treatment of impotence may apply.


Rationale

After an initial literature search was performed in 2001, the policy was updated regularly with a literature review using MEDLINE. Most recently, the literature was searched from October 2011 through October 2012. Following is a summary of the literature to date:

The first randomized controlled trial (RCT) that evaluated nerve grafting was published in 2009 by Davis and colleagues. (1) Eligibility criteria included age 65 years or younger, normal self-report baseline erectile function, and scheduled for a unilateral nerve-sparing radical prostatectomy with preservation of one neurovascular bundle. All patients had the other neurovascular bundle removed, and patients were randomly assigned to receive or not receive sural nerve-grafting after its removal. The primary outcome was potency 2 years post-surgery, defined as the ability to have intercourse with or without erectile dysfunction medication. The investigators estimated that the control group would have a 40% potency rate and powered the study to detect an absolute difference of 20% between groups. All patients received the same early erectile dysfunction therapy including medication and mechanical devices. A sample size of 200 was originally planned to provide 80% power. However, after 107 patients were randomly assigned, a pre-planned interim analysis of evaluable patients found similar rates of potency in the 2 groups; the Data Monitoring Committee estimated that there was less than a 5% chance that there would be a significant difference between groups with additional recruitment and the trial was stopped early. When data collection ended, endpoint data were available for 66 patients who had either achieved potency or had been followed up for 2 years without potency. Potency was achieved in 32 of 45 (71%) sural nerve-graft patients and 14 of 21 (67%) control patients (p=0.78). The authors concluded that unilateral sural nerve-graft did not result in an absolute improvement of 20% in the rate of potency but that a smaller effect cannot be ruled out. A limitation of the study was that it was non-blinded, which could have impacted self-report of potency.

Other than the Davis et al. study, the published literature consists of case series. When the initial literature search was performed, the largest available series included 23 men with a mean of 23-month follow-up. (2) This study, by Kim et al., included men with clinically localized but high-volume prostate cancer such that bilateral resection of the neurovascular bundles was considered necessary. Before surgery, all men reported spontaneous erection. The results were compared to a group of 12 men who were potent preoperatively and had undergone prostatectomy with bilateral nerve resection but who declined nerve-graft placement. Of the 23 men undergoing nerve grafting, 6 (26%) had spontaneous, medically unassisted erection sufficient for sexual intercourse. An additional 6 men (26%) reported 40% to 60% spontaneous erection that was insufficient for intercourse; 4 of these patients were able to have intercourse using sildenafil. Therefore, a total of 10 of the 23 patients were able to have intercourse, either spontaneously or with pharmacologic therapy. A total of 11 men had no clinical response even with the use of sildenafil. Not unexpectedly, all outcomes were significantly better compared to the control group. Side effects of the sural nerve donor site, which included incisional pain and a sensory deficit along the lateral aspect of the foot, were considered tolerable. The authors noted improvement 8 to 12 months postoperatively and accelerated improvement at 12 to 18 months postoperatively.

Subsequent literature searches identified additional case series. The largest published series and those with the longest follow-up are described below:

In 2007, Namiki and colleagues published a series in Japan with 3-year follow-up.(3) A total of 113 patients were evaluated: 19 patients with unilateral nerve-sparing plus sural nerve graft, 60 patients with unilateral nerve-sparing but no grafting, and 34 patients with bilateral nerve-sparing surgery. Sexual function was assessed with validated questionnaires, and at 2 years, there was no difference between the nerve-grafted and the bilateral nerve-sparing patients with regard to sexual function scores. At 3 years, 25% and 28% of patients in the nerve-grafted and bilateral nerve-sparing groups, respectively, considered their sexual function as fair or good. Urinary function returned to baseline in the nerve-grafted and bilateral nerve-sparing groups at 6 months and in the unilateral nerve-sparing group at 12 months. Differences in sexual function were present at baseline with the nerve-grafted and bilateral nerve-sparing patients reporting higher baseline function than the unilateral nerve-sparing group.

A study by Secin and colleagues had 5-year follow-up.(4) The authors reported results on 44 consecutive patients who underwent bilateral nerve grafting from 1999 to 2004 at Memorial Sloan-Kettering Cancer Center. The overall 5-year recovery of erectile function was 34%, and the rate of consistent function was 11%. None of a number of variables (e.g., age, type of nerve [sural, genitofemoral, ilioinguinal], comorbidities) was significantly associated with recovery of postoperative erectile function.

Sim et al. reported on 2-year results in 41 patients who received unilateral sural nerve grafts following radical prostatectomy when 1 neurovascular bundle was resected.(5) In this series, recovery of erectile function was reported for 63% of patients (based on 24 of 38 patients). This study also reported on erectile function on another group of patients who had unilateral resection at the same institution but without a nerve graft. In this group, which was older and was not matched on key characteristics to the group who received a nerve graft, the erectile function was 26.5% (13 of 49).

A recent case series reviewed the records of 131 men who had unilateral nerve grafts after radical prostatectomy with unilateral neurovascular bundle resection. (6) Men who had prior radiation or hormonal treatment were excluded. Another eligibility criterion was satisfactory erections presurgery as assessed by a 5-point scale (1=full erections; 2=diminished erections, but routinely sufficient for sexual intercourse; 3=partial erections occasionally satisfactory for intercourse; 4=partial erections unsatisfactory for intercourse; and 5=no erections). A total of 49 men received sural nerve grafts, 79 received genitofemoral nerve grafts, and 3 received ilioinguinal nerve grafts. Recovery of erections was evaluated at each follow-up visit according to the 5-point scale (also called 5 levels). The median patient age was 58.7 years, and the median follow-up was 37 months. According to actuarial analysis, the 5-year probability of recovering erections of level 3 or better was 46%. The probability of recovering erections of at least level 2 or level 1 was 34% and 12%, respectively.

Ongoing Clinical Trials

A search of the online ClinicalTrials.gov database in October 2011 did not identify any ongoing trials on nerve grafting but did identify a single-arm pilot study on a related topic, nerve reconstruction in conjunction with robotic-assisted prostatectomy. (7) The study evaluates the use of AVANCE, an allograft tissue product, for nerve reconstruction and is sponsored by the manufacturer of AVANCE. Technical feasibility is the primary outcome, and erectile function is one of the secondary outcomes.

Clinical Input Received Through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received from 4 academic medical centers while this policy was under review in 2008; no input was received from physician specialty societies. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. Input from these 4 centers agreed that this procedure is considered investigational as adopted in the policy in May 2008.

Summary

Nerve-grafting, most commonly using the sural nerve, at the time of radical prostatectomy has been proposed to reduce the risk of postoperative erectile dysfunction. Only one randomized controlled trial that evaluated sural nerve-grafting with radical prostatectomy has been published, and this study did not find that unilateral nerve-grafting was associated with a statistically significant improvement in potency rates 2 years post-surgery. Due to the negative findings of this study, and the lack of other controlled studies evaluating unilateral or bilateral nerve grafting, the technique is considered investigational.

Practice Guidelines and Position Statements

The 2012 National Comprehensive Care Network (NCCN) prostate cancer guideline states that replacement of resected nerves has not been shown to be beneficial for recovery of erectile function after radical prostatectomy. (8)

Medicare National Coverage

No national coverage determination.

References:

    1. Davis JW, Chang DW, Chevray P et al. Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. Eur Urol 2009; 55(5):1135-43.
    2. Kim ED, Nath R, Slawin KM et al. Bilateral nerve grafting during radical retropubic prostatectomy: extended follow-up. Urology 2001; 58(6):983-7.
    3. Namiki S, Saito S, Nakagawa H et al. Impact of unilateral sural nerve graft on recovery of potency and continence following radical prostatectomy: 3-year longitudinal study. J Urol 2007; 178(1):212-6; discussion 16.
    4. Secin FP, Koppie TM, Scardino PT et al. Bilateral cavernous nerve interposition grafting during radical retropubic prostatectomy: Memorial Sloan-Kettering Cancer Center experience. J Urol 2007; 177(2):664-8.
    5. Sim HG, Kliot M, Lange PH et al. Two-year outcome of unilateral sural nerve interposition graft after radical prostatectomy. Urology 2006; 68(6):1290-4.
    6. Rabbani F, Ramasamy R, Patel MI et al. Predictors of recovery of erectile function after unilateral cavernous nerve graft reconstruction at radical retropubic prostatectomy. J Sex Med 2010; 7(1 Pt 1):166-81.
    7. Study of nerve reconstruction using AVANCE in subjects who undergo robotic assisted prostatectomy for treatment of prostate cancer (NCT00953277). Available online at: ClinicalTrials.gov. Last accessed November, 2012.
    8. National Comprehensive Cancer Network. Prostate Cancer. Clinical practice guidelines in oncology, v3.2012. Available online at: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Last accessed November, 2012.

 

Codes

Number

Description

CPT 64999 Unlisted procedure, nervous system
  55840 – 55845 Radical retropubic prostatectomy, code range
ICD-9 Procedure    
ICD-9 Diagnosis 185 Malignant neoplasm of prostate
  607.84 Impotence of organic origin
  997.99 Complications affecting other specified body systems, not elsewhere classified, other (to be reported with 607.84 when the impotence is a result of a previous radical prostatectomy)
  V45.77 Other postprocedural states; acquired absence of genital organs
HCPCS    
ICD-10-CM (effective 10/1/14)   Investigational for all relevant diagnoses
  C61 Malignant neoplasm of prostate
  N52.01-N52.9 Male erectile dysfunction code range (includes N52.31 Erectile dysfunction following radical prostatectomy)
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
  0VT00ZZ Surgical, male reproductive system, resection, prostate, open
Type of Service Surgery  
Place of Service Inpatient  


Index

Genitofemoral Nerve Graft, Prostatectomy
Nerve Graft, Prostatectomy
Prostatectomy, Genitofemoral Nerve Graft
Prostatectomy, Sural Nerve Graft
Sural Nerve Graft, Prostatectomy


Policy History

Date Action Reason
11/20/01 Add to Surgery section New policy
04/29/03 Replace policy Policy revised; sural nerve grafting now considered investigational
11/9/04 Replace policy Policy updated, reference added, no change in policy statement (editorial correction made to policy statement language)
08/17/05 Replace policy Policy updated with literature search, no change in policy statement
04/17/07 Replace policy Policy updated with literature search, no change in policy statement. “Sural nerve graft” replaced with “Nerve graft” in title and policy. Reference numbers 4 to 6 added
05/08/08 Replace policy Policy updated with literature search; reference numbers 7 and 8 added; clinical input reviewed. No change in policy statement
12/10/09 Replace policy Literature review update through October 2009; Rationale extensively rewritten; Reference number 1 added; other references re-numbered/removed. No change in policy statement.
12/09/10 Replace policy Literature review update through October 2010. Reference numbers 6 to 8 added. No change in policy statement.
12/08/11 Replace policy Literature review update through October 2011. No change in policy statement.
12/13/12 Replace Policy
Literature review update through October 2012. No change in policy statement.