Archived Policies - Surgery
Nerve Graft in Association with Radical Prostatectomy
This policy is no longer scheduled for routine literature review and update.
Unilateral or bilateral nerve graft in patients who have undergone resection of one or both neurovascular bundles as part of a radical prostatectomy is considered experimental, investigational and unproven.
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 report results from bilateral nerve grafts. They also report on 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.
Limited data are published regarding the long-term outcomes of sural nerve grafting. The largest study reported is a case series of 23 men with a mean 23-month follow-up. All men had 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. Outcomes included assessment of erectile function based on the International Index of Erectile Function, visual assessment and assessment by patients’ partners. Patients were also encouraged to use a variety of erectile dysfunction treatments, including intracavernosal injections, vacuum constriction devices or sildenafil citrate as needed. 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 graft, six (26%) had spontaneous, medically unassisted erections sufficient for sexual intercourse. An additional six men (26%) reported 40% to 60% spontaneous erections that were insufficient for intercourse. Four 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 eight to 12-months postoperatively and accelerated improvement at 12- to 18-months postoperatively. In addition, there are reports from the same group of surgeons who reported in 2001 that some 220 sural nerve grafts had been performed at their institution. Some surgeons had performed unilateral sural nerve grafts. However, without a controlled study in this population, it will be difficult to isolate the contribution of the sural nerve graft compared to the spontaneous recovery of erectile activity. In summary, the data are insufficient to permit scientific conclusions regarding the long-term effectiveness of sural nerve grafting in men undergoing prostatectomy.
A search of the literature did not identify any additional published articles that would alter the above conclusions; therefore, the coverage position remains investigational. Singh and colleagues investigated whether unilateral sural nerve graft would improve urinary function after radical prostatectomy. Patients with and without a sural nerve graft were invited to complete a questionnaire. Twelve months after surgery, 94.7% of patients with a sural nerve graft reported complete urinary control compared to 58.3% without a sural nerve graft. The authors concluded that these preliminary results required validation in larger, multi-center and prospective randomized studies. No additional studies were identified that focused on the outcome of potency.
A review of the literature was conducted based on the MEDLINE database for the period of 2006 through June 2007. Secin and colleagues reported results on 44 consecutive patients who underwent bilateral nerve grafting from 1999 to 2004 at Memorial Sloan-Kettering Cancer Center. The overall five-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. The authors concluded that nerve grafts might be beneficial in select patients, but a randomized, controlled trial was needed.
Sim reported on two-year results in 41 patients who received unilateral sural nerve grafts following radical prostatectomy when one neurovascular bundle was resected. This study was conducted from 2000 to 2003. 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. This group was older and was not matched on key characteristics to the group who received a nerve graft, and the erectile function was 26.5% (13 of 49). Nelson reported on results of using genitofemoral nerve grafts in 27 patients (five with bilateral grafts) with radical prostatectomy. At a mean follow-up of 14-months, 56% of patients reported erectile function sufficient for penetration. The authors noted uncertainty about whether their findings were a consequence of an effective unilateral nerve-sparing dissection or of the nerve grafting.
While these studies demonstrate that unilateral or bilateral nerve grafting is feasible, whether or not this technique results in improved patient outcomes following radical prostatectomy requires further study in randomized, controlled trials. Thus, the coverage position is unchanged.
A search of peer reviewed literature through July 2009 identified studies that were small, single-center cohort studies, with some having non-grafted comparison groups. Several studies report small numbers of patients or bilateral grafting that are insufficient for making comparisons or conclusions.
Zorn reported the experience of 27 (23 unilateral, four bilateral) sural nerve grafts on sexual and urological function over a mean of 26 months. Several comparisons were made using their prospectively collected database of non-grafted patients. At one-year, continence rates were not different for the grafted and non-grafted but nerve(s)-spared groups. Sexual function was defined using validated questionnaires, and 24 of 27 nerve-grafted patients were potent preoperatively. No differences between unilateral nerve graft and unilateral nerve sparing with no grafting were noted with respect to return to baseline sexual function. At mean follow-up of 26 months, 47.8% of unilaterally grafted patients had regained potency, compared to 56% for age-matched unilateral nerve sparing with no grafting.
Namiki et al. published a three-year study from Japan of the results of unilateral sural nerve graft on recovery of sexual and urological function. A total of 113 patients were compared: 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 two-years there was no difference between the nerve-grafted and the bilateral nerve-sparing patients with regard to sexual function scores. At three-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 six-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.
Hanson and colleagues described outcomes of erectile function following unilateral cavernosal nerve replacement for 40 patients. Median follow-up was 19 months, at which 21 of 29 patients (72%) reported being able to penetrate after prostatectomy. Sixteen of those 21 continued to require phosphodiesterase type 5 (PDE-5) inhibitors to facilitate penetration.
A retrospective review of 36 patients who underwent cavernous nerve interposition grafting for a three-year period was published in 2009. Postoperative erectile function was assessed by questionnaire. Predictors of potency, including age at surgery, time since surgery, and prostate specific antigen at surgery were accessed as well. A total of 33 patients (92%) were followed for a median of 32-months (10 patients having had bilateral grafting during radical cystectomy), 25-months (20 patients having had unilateral grafting during radical prostatectomy), 11-months (three patients having had bilateral grafting during radical cystectomy and prostatectomy). The rate of potency, defined as the ability to attain and maintain erection sufficient for penetration was at least 50% of the time with or without the use of PDE-5 inhibitors, was 31% (five of 13 men) for unilateral grafts, 38% (five or 16) for bilateral grafts, and 30% (three of ten) for bilateral grafts during radical cystectomy.
Randomized trials are still warranted to discern the effects of nerve grafting and nerve sparing and to remove selection biases present in the current studies. The coverag statement remains unchanged.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
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.
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, grafting and radical prostatectomy.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed or changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
Canto, E.L., Nath, R.K., et al. Cavermap-assisted sural nerve interposition graft during radical prostatectomy. Urologic Clinics of North America (2001) 28(4):839-48.
Kim, E.D., Nath, R., et al. Bilateral nerve grafting during retropubic prostatectomy: extended follow up. Urology (2001 December) 58(6):983-7.
Singh, H., Karakiewicz, P., et al. Impact of unilateral interposition sural nerve grafting on recovery of urinary function after radical prostatectomy. Urology (2004 June) 63(6):1122-7.
Nelson, B.A., Chang, S.S., et al. Morbidity and efficacy of genitofemoral nerve grafts with radical retropubic prostatectomy. Urology (2006 April) 67(4):789-92.
Sim, H.G., Kliot, M., et al. Two-year outcome of unilateral sural nerve interposition graft after radical prostatectomy. Urology (2006 December) 68(6):1290-4.
Nerve Graft in Association with Radical Prostatectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2007 February) Surgery 7.01.81.
Secin, F.P., Koppie, T.M., et al. Bilateral cavernous nerve interposition grafting during radical retropubic prostatectomy: Memorial Sloan-Kettering Cancer Center experience. The Journal of Urology (2007 February) 177(2):664-8.
Namiki, S., Saito, S., et al. Impact of unilateral sural nerve graft on recovery of potency and continence following radical prostatectomy: three year longitudinal study. The Journal of Urology (2007 May 11) 178(1):212-6.
Hanson, G.R., Borden, L.S., et al. Erectile function following unilateral cavernosal nerve replacement. Canadian Journal of Urology (2008 April) 15(2):3990-3.
Nerve Graft in Association with Radical Prostatectomy. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2008 May) Surgery 7.01.81.
Satkunasivam, R., Appu, S., et al. Recovery of erectile function after unilateral and bilateral cavernous nerve interposition grafting during radical pelvic surgery. Journal of Urology (2009 March) 181(3):1258-63.
9/1/2009 Revised/updated entire document. Coverage remains experimental, investigational and unproven.
9/1/2007 Revised/updated entire document8/15/2003 New medical document
|Title:||Effective Date:||End Date:|
|Nerve Graft With Radical Prostatectomy||01-01-2018||11-14-2018|
|Nerve Graft With Radical Prostatectomy||07-15-2017||12-31-2017|
|Nerve Graft With Radical Prostatectomy||01-01-2017||07-14-2017|
|Nerve Graft in Association With Radical Prostatectomy||05-15-2015||12-31-2016|
|Nerve Graft in Association With Radical Prostatectomy||07-01-2014||05-14-2015|
|Nerve Graft in Association with Radical Prostatectomy||10-15-2013||06-30-2014|
|Nerve Graft in Association with Radical Prostatectomy||09-01-2009||10-14-2013|
|Nerve Graft in Association with Radical Prostatectomy||09-01-2007||08-31-2009|
|Sural Nerve Graft in Association with Radical Prostatectomy||08-15-2003||08-31-2007|