Minimally invasive options have also been researched, in which some portion of the disc is removed or ablated, although these techniques are not precisely targeted at the offending extruding disc material. Ablative techniques include laser discectomy and radiofrequency decompression (see separate policy on 'Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)' - Policy #077 in the Treatment Section). Intradiscal electrothermal annuloplasty is another minimally invasive approach to low back pain. In this technique, radiofrequency energy is used to treat the surrounding disc annulus (see separate policy on 'Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty' - Policy #023 in the Treatment Section)

Herein, the policy addresses automated percutaneous and endoscopic discectomy, in which the disc decompression is accomplished by the physical removal of disc material rather than its ablation. Traditionally, discectomy was performed manually through an open incision, using cutting forceps to remove nuclear material from within the disc annulus. This technique was modified by automated devices that involve placement of a probe within the intervertebral disc and aspiration of disc material using a suction cutting device. Endoscopic techniques may be intradiscal or may involve extraction of noncontained and sequestered disc fragments from inside the spinal canal using an interlaminar or transforaminal approach. Following insertion of the endoscope, decompression is performed under visual control.

Regulatory Status

The Dekompressor® Percutaneous Discectomy Probe (Stryker), Herniatome Percutaneous Discectomy Device (Gallini Medical Devices), and the Nucleotome® (Clarus Medical) are examples of percutaneous discectomy devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA indication for these products is for "aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine." FDA product code: HRX.

A variety of endoscopes and associated surgical instruments have also been cleared for marketing by FDA through the 510(k) process.

A variety of endoscopes and associated surgical instruments have also been cleared for marketing by FDA through the 510(k) process.

Related Policies

• Discectomy (Policy #142 in the Surgery Section)
• Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty) (Policy #077 in the Treatment Section)
• Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty (Policy #023 in the Treatment Section)

(NOTE: Tubular discectomy is considered a variant of open discectomy with the only difference being the type of retraction used.)

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Automated Percutaneous Discectomy
Clinical Context and Therapy Purpose

The purpose of automated percutaneous discectomy in patients who have herniated intervertebral disc(s) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of automated percutaneous discectomy improve the net health outcome in individuals with herniated intervertebral disc(s)?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is individuals with herniated intervertebral disc(s).

Interventions

The therapy being considered is automated percutaneous discectomy.

Percutaneous discectomy is provided in a hospital setting with specialized staff, equipped to perform the surgical procedure and postsurgical care.

Comparators

The following therapies and practices are currently being used to treat herniated intervertebral disc(s): conservative therapy and open discectomy or microdiscectomy.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Specific outcomes measured by specific instruments may include improvements in functional outcomes assessed on the Oswestry Disability Index (ODI), reductions in pain using a visual analog scale (VAS), improvements in quality of life measured on the 36-Item Short-Form Health Survey (SF-36) and Euro-QOL-5D, and treatment-related morbidity including surgical success/failure and complications. To assess outcomes, follow-up at 1 year is considered appropriate.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Systematic reviews have assessed automated percutaneous discectomy compared to other interventions; however, the majority of these reviews contained observational studies published more than a decade ago with generally small patient populations and inconsistent results. Lewis et al (2015) published the most recent systematic review and network meta-analysis comparing trials of 21 different treatment strategies for sciatica.^1,Examples of the 21 treatment strategies included in the analysis include conservative care, disc surgery, intraoperative interventions, epidural injections, biologic agents, and percutaneous discectomy. Under the category of "percutaneous discectomy," reviewers combined automated percutaneous discectomy, percutaneous automated nucleotomy, nucleoplasty, and laser discectomy. They searched 28 databases and trial registries through December 2009. Ninety studies were included and 10 involved the percutaneous discectomy category as an intervention. Of the 10, 4 are relevant to this policy: 2 case-control studies of percutaneous endoscopic discectomy (2006, 2007), 1 RCT of percutaneous endoscopic discectomy (1993), and 1 RCT of automated percutaneous discectomy (1995). The remaining studies were published in a foreign language or involved other comparators (nucleolysis, chemonucleolysis). The global effects odds ratio for the category of percutaneous discectomy compared with inactive control was 0.82 (95% confidence interval, 0.39 to 1.72), which was inferior to disc surgery, epidural injections, and intraoperative interventions. The pain intensity weighted mean difference for the category of percutaneous discectomy compared with inactive control was 11.5 (95% confidence interval, -18.6 to 41.6). Reviewers concluded that there was no support for the effectiveness of percutaneous discectomy for the treatment of sciatica. Due to the inclusion of additional interventions into the broad category of percutaneous discectomy in this review, the relevance of these results to this policy is limited.

Randomized Controlled Trials

The 2002 Lumbar Automated Percutaneous Discectomy Outcomes Group(LAPDOG) trial is the most recent RCT to compare automated percutaneous discectomy with open discectomy in patients with lumbar disc herniation.^2, No additional RCTs have been identified since the 2002 LAPDOG trial. The trial was designed to recruit 330 patients but enrolled 36 patients for reasons not readily apparent. Twenty-seven patients were available at follow-up, with efficacy reported by 41% of those undergoing automated percutaneous discectomy and by 40% of those undergoing conventional discectomy. The trialists concluded that "It is difficult to understand the remarkable persistence of percutaneous discectomy in the face of a virtually complete lack of scientific support for its effectiveness in treated lumbar disc herniation." The tables below more fully describe key characteristics, results, and limitations of the LAPDOG trial.

Table 1. Characteristics of the LAPDOG Trial

Study	Countries	Sites	Dates	Participants	Interventions
Haines et al (2002)2,	US, Canada	10	NR	Patients with predominantly unilateral leg pain or paresthesia with no previous treatment for lumbar spinal disease, at least 2 of 4 objective signs, and an imaging study confirming disc herniation at the appropriate level	Automated percutaneous discectomy vs. conventional discectomy

LAPDOG: Lumbar Automated Percutaneous Discectomy Outcomes Group; NR: not reported.

Table 2. Results of the LAPDOG Trial

Study	Treatment successa  (at 6 months)	Treatment failureb  (at 6 months)	SF-36 Physical Functioning Subscore	SF-36 General Health Subscore	Modified Roland Score
Haines et al (2002)2,
N	27	27	NR	NR	NR
Automated percutaneous discectomy,	7 (41%)	10 (59%)	Pre- vs. postoperative mean difference: 35.7	Pre- vs. postoperative mean difference: 5.0	Pre- vs. postoperative mean difference: 9.7
Conventional discectomy	4 (40%)	6 (60%)	Pre- vs. postoperative mean difference: 36.1	Pre- vs. postoperative mean difference: 8.0	Pre- vs. postoperative mean difference: 10.6
p	0.95	0.95	0.96	0.58	0.74

LAPDOG: Lumbar Automated Percutaneous Discectomy Outcomes Group; NR: not reported.

^aSuccess was defined as either an excellent or good result as defined by an outcome matrix.
^bFailure was defined as not achieving success or requiring a second procedure during the follow-up period.

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-upe
Haines et al (2002)2,	4. Investigators believed that study inclusion criteria reflected an existing population with lumbar disc disease; however, results from only 27 patients were eventually analyzed from a planned enrollment of 330 patients			4. Primary outcomes of "success" or "failure" largely subjective in nature; investigators admit that the outcome measurement tool used can not be precisely reproduced	1,2. Outcomes reported only for 6 months of follow-up; 12 month follow-up was achieved for only 19 patients and the study did not report any of these results

^aPopulation key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^bIntervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^cComparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^dOutcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^eFollow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Haines et al (2002)2,		1,2. Blinding did not appear to occur		1. Of 34 initially randomized patients, 9 were lost to follow-up, 6 month follow-up data was obtained on only 27 patients, and 12 month follow-up data was obtained for only 19 patients	3. Power estimates led the investigators to plan enrollment of 330 patients in order to reliably identify a difference in success rate of 15% or greater; results were analyzed on 27 patients	1. Beyond the cursory discussion of lack of power, a discussion of the statistical analyses is nonexistent

^aAllocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^bBlinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^cSelective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^dData Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^ePower key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power
^fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Automated Percutaneous Discectomy

The evidence for automated percutaneous discectomy in individuals who have herniated intervertebral disc(s) includes small RCTs and systematic reviews. Evidence from small RCTs does not support the use of this procedure. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis. However, the clinical input is not generally supportive of a clinically meaningful improvement in net health outcome. Further details from clinical input are included in the Clinical Input section later in the review and the Appendix.

Percutaneous Endoscopic Discectomy
Clinical Context and Therapy Purpose

The purpose of percutaneous endoscopic discectomy in patients who have herniated intervertebral disc(s) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of percutaneous endoscopic discectomy improve the net health outcome in individuals with herniated intervertebral disc(s)?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is individuals with herniated intervertebral disc(s).

Interventions

The therapy being considered is percutaneous endoscopic discectomy.

Comparators

The following therapies and practices are currently being used to treat herniated intervertebral disc(s): conservative therapy and open discectomy or microdiscectomy.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Specific outcomes measured by specific instruments include improvements in functional outcomes assessed on the ODI, reductions in pain using a VAS, improvements in quality of life measured on the SF-36 and Euro-QOL-5D, and treatment-related morbidity including surgical success/failure and complications. To assess outcomes, follow-up at 1 year is considered appropriate.

Percutaneous endoscopic discectomy is provided in a hospital setting with specialized staff, equipped to perform the surgical procedure and postsurgical care.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

A number of systematic reviews have evaluated the efficacy and safety of percutaneous endoscopic discectomy to open discectomy or microendoscopic discectomy (MED). A comparison of the trials included in more recent systematic reviews (2016 to present) is shown in Table 5. The systematic reviews included a total of 46 trials published between 1993 and 2018. Characteristics and results of these reviews are summarized in Tables 6 and 7.

Table 5. Trials Included in Systematic Reviews of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

Trials	Systematic Reviews
	Cong et al (2016)4,	Li et al (2016)5,	Phan et al (2017)6,	Shi et al (2019)7,	Yu et al (2019) 8,	Xu et al (2020) 9,
Yoon et al (2012)10,			⚫	⚫	⚫	⚫
Li et al (2015)11,			⚫			⚫
Sinkemani et al (2015)12,			⚫	⚫	⚫	⚫
Song et al (2017)13,				⚫	⚫	⚫
Tu et al (2017)14,						⚫
Liu et al (2018)15,				⚫	⚫	⚫
Li et al (2018)16,				⚫	⚫	⚫
Abdurexiti et al (2018)17,				⚫	⚫	⚫
Chen et al (2018)18,				⚫	⚫	⚫
Liu et al (2012)19,					⚫
Wu et al (2009)20,				⚫
Yang et al (2015)21,				⚫
Duan et al (2016)22,				⚫
Zhao et al (2016)23,				⚫
Ding et al (2017)24,				⚫
Li et al (2017)25,				⚫
Liu et al (2017)26,				⚫
Luo et al (2017)27,				⚫
Qu et al (2017)28,				⚫
Chen et al (2018)29,				⚫
Wu et al (2018)30,				⚫
Belykh et al (2016)31,				⚫
Chen et al (2015)32,			⚫
Choi et al (2016)33,			⚫
Garg et al (2011)34,	⚫		⚫
Hermantin et al (1999)35,	⚫		⚫
Huang et al (2005)36,			⚫
Hussein et al (2014)37,	⚫		⚫
Kleinpeter et al (1995)38,			⚫
Lee et al (2009)39,		⚫	⚫
Martin-Laez et al (2012)40,			⚫
Mayer et al (1993)41,			⚫
Ohya et al (2016)42,			⚫
Pan et al (2014)43,			⚫
Righesso et al (2007)44,	⚫		⚫
Ruetten et al (2008)45,	⚫	⚫	⚫
Ruetten et al (2009)46,	⚫	⚫	⚫
Sasaoka et al (2006)47,			⚫
Schizas et al (2005)48,			⚫
Teli et al (2010)49,	⚫		⚫
Ruetten et al (2007)50,			⚫
Ruetten et al (2009)51,		⚫
Ruetten et al (2008)52,		⚫
Wang et al (2011)53,		⚫
Lee et al (2006)54,	⚫
Liu et al (2014)55,	⚫

Table 6. Summary of Systematic Reviews of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

Study	Dates	Trials	Participants	N (Range)	Design	Duration
Xu et al (2020)9,	Search dates not stated; included trials from 2012 to 2018	9	Patients with single-level lumbar disc herniation who underwent PELD or MED for treatment	984 (51-216)	1 Prospective RCTs 8 Retrospective nonrandomized comparative studies	Follow-up: 1 to > 6 years
Yu et al (2019)8,	To August 31, 2018	8	Patients with lumbar disc herniation who underwent PTED or MED procedures and were followed for at least 6 months	805 (51-216)	1 Prospective RCTs 7 Observational studies	Follow-up: 6 months to 5 years
Shi et al (2019)7,	To July 2018	18	Patients with single-level lumbar disc herniation with sciatica who underwent PELD or MED for treatment	2161 (51-273)	8 Prospective studies; 10 Retrospective studies	Follow-up: 3 months to >6 years
Phan et al (2017)6,	To February 2016	23	Patients who underwent either an endoscopic or open approach for disc herniation; the endoscopic approach consisted of patients who underwent either FED or MED while the open approach included those who underwent open discectomy or micro-discectomy	28,487 (20-26,612)	10 Prospective RCTs 4 Prospective observational studies 9 Retrospective observational studies	Follow-up: 3 to 104 months
Li et al (2016)5,	To January 31, 2015	6	Patients with disc herniation who underwent traditional discectomy surgery or full endoscopic procedures	730 (54-200)	4 RCTs; 2 non-RCTs	Follow-up: 20 to 34 months
Cong et al (2016)4,	To August 2014	9	Patients who underwent spinal endoscopic or open discectomy for symptomatic lumbar disc herniation	1092 (40-212)	9 RCTs	Follow-up: at least 1 year

FED: full-endoscopic technique discectomy; MED: microendoscopic discectomy; PELD: percutaneous endoscopic lumbar discectomy; PTED: percutaneous transforaminal endoscopic discectomy; RCT: randomized controlled trial

Table 7. Results of Systematic Reviews of Trials of Percutaneous Endoscopic Discectomy Versus Other Discectomy Procedures

Study	Length of stay	Leg pain VAS	Lower back pain VAS	ODI	Overall complication rate	Reoperation	Recurrence or residue
Xu et al (2020)9,
Total (N)	NR	NR	NR	NR	NR	NR	NR
Pooled effect (95% CI)	OR -1.041 (-1.493 to -0.583); 0.000	6 months to 2 years OR -0.138 (-0.384 to 0.108); 0.270 2 years OR 0.020 (-0.193 to 0.233); 0.855	6 months to 2 years -0.456 (-0.947 to 0.034); 0.068 2 years OR -0.856 (-1.488 to -0.224); 0.008	6 months to 2 years -0.077 (-0.370 to 0.215); 0.604 2 years OR -0.425 (-0.724 to -0.127); 0.005	OR 0.972 (0.635 to 1.488); 0.896	OR 1.136 (0.415 to 3.108); 0.805	OR 1.306 (0.664 to 2.566); 0.439
I2 (p)		53.8%; 0.090; 6 months to 2 years 4.4%; 0.351; 2 years	88%; 0.000; 6 months to 2 years 86.7%; 0.001; 2 years	75.3%; 0.000; 6 months to 2 years 52.7%; 0.121; 2 years
Yu et al (2019)8,
Total (N)	707	NR	NR	NR	659		443
Pooled effect (95% CI)	MD -1.92 (-2.90 to -0.94); <0.001	1 year postop or last follow-up: MD -0.07 (-0.22 to 0.08); 0.38	1 year postop or last follow-up: MD -0.41 (-0.76 to -0.06); 0.02	1 year postop or last follow-up: MD -0.27 (-1.71 to 1.16); 0.71	MD 1.01 (0.60 to 1.69); 0.98		MD 1.31 (0.54 to 3.17); 0.54
I2 (p)	88%				0%		0%
Shi et al (2019)7,
Total (N)	1717	742	742	1337	1527	805	928
Pooled effect (95% CI)	MD -2.29 (3.03 to -1.55); <0.00001	At last follow-up: MD -0.18 (-0.45 to 0.09); 0.19	At last follow-up: MD -0.77 (-1.31 to -0.24); 0.005	At last follow-up: MD -0.30 (-1.02 to 0.42); 0.41	OR 0.96 (0.65 to 1.43); 0.85	OR 2.67 (1.07 to 6.67); 0.04	OR 2.22 (1.02 to 4.83); 0.05
I2 (p)	96%; <0.00001	88%; <0.00001	95%; <0.00001	55%; 0.01	0%; 0.90	0%; 0.79	0%; 0.86
Phan et al (2017)6,
Total (N)	685	390		303	27,699	995	1081
Pooled effect (95% CI)	MD -4.79 (-6.52 to -3.07); <0.00001	MD -0.04 (-0.37 to 0.30); 0.84		MD -1.88 (-4.06 to 0.29); 0.09	OR 0.77 (0.45 to 1.31); 0.33	OR 1.46 (0.33 to 6.43); 0.61	OR 1.12 (0.60 to 2.09); 0.73
I2 (p)	99%; <0.00001	70%; 0.003		67% (0.03)	60%; 0.004	66%; 0.004	0%; 0.97
Li et al (2016)5,
Total (N)	320 (cervical); 410 (lumbar)	410	410	354	730	674
Pooled effect (95% CI)	Cervical: WMD -9.33 (-20.11 to 1.44); 0.09 Lumbar: WMD -12.16 (-17.24 to -7.09); <0.001	At 2 years: -0.58 (-1.46 to 0.29); 0.19	At 2 years: -1.98 (-6.36 to 2.40); 0.38	At 2 years: 1.60 (-5.17 to 8.38); 0.64	RR 0.35 (0.19 to 0.63); <0.001	RR 1.02 (0.59 to 1.75); 0.94
I2 (p)	Cervical: 97% Lumbar: 97%	44%; 0.15	93%; <0.001	21%; 0.28	0%	0%
Cong et al (2016)4,
Total (N)	NR				NR	NR	NR
Pooled effect (95% CI)	WMD -144.45 (-239.54 to -49.37); 0.003				OR 0.73 (0.34 to 1.57); 0.41	OR 0.98 (0.60 to 1.61); 0.93	OR 1.62 (0.84 to 3.12); 0.15
I2 (p)	99%				75%	0%	0%

CI: confidence interval; NR: not reported; MD: mean difference; ODI: Oswestry Disability Index; OR: odds ratio; RR: risk ratio; VAS: visual analogue scale; WMD: weighted mean difference

Results from the systematic reviews were fairly consistent with a significantly reduced length of hospitalization observed with endoscopic discectomy and sometimes significant improvements in VAS or ODI, but only at specific time points. Overall, no consistently significant improvement in VAS, ODI, total complication rate, reoperation, or recurrence was observed with endoscopic discectomy versus other interventions. Authors of the systematic reviews noted multiple limitations including the innate flaws of included studies (ie, observational designs, a limited number of studies meeting criteria for inclusion, small sample sizes, lack of allocation concealment and blinding), different methodologies contributing to heterogeneity in analyses, loss of usable and sufficient data resulting in difficulty performing accurate analysis of outcomes, and that a majority of the more recently completed studies were completed in China, which may affect the generalizability of the results to other populations.

Randomized Controlled Trials

A total of 48 trials comparing percutaneous endoscopic discectomy to other discectomy procedures are included in this policy. Forty-six of these trials were included in at least 1 systematic review (Table 5). Two additional more recent RCTs not included in any of the systematic reviews were identified.^56,;^57, Results of these trials were similar to those seen in the more comprehensive systematic reviews - percutaneous endoscopic discectomy was associated with a significant reduction in length of stay with no consistent improvement in patient-reported outcome measures such as VAS and ODI. Additionally, the trials did not assess any treatment-related morbidities including overall complication, reoperation, and recurrence rates. Key characteristics, results, and limitations of these RCTs are summarized in the following tables.

Table 8. Characteristics of RCTs of Percutaneous Endoscopic Discectomy

Study	Countries	Sites	Dates	Participants	Interventions
Wang et al 201956,	China	1	July 2015 to July 2016	Patients with single-segment lumbar disc herniation with imaging results consistent with symptoms	Percutaneous transforaminal endoscopic discectomy vs microendoscopic discectomy
Gibson et al 201757,	United Kingdom	1	May 2006 to January 2015	Patients with a single level prolapse with exiting and/or transversing nerve root compression and failure of conservative management	Transforaminal endoscopic discectomgy vs. microdiscectomy

Table 9. Results of RCTs of Percutaneous Endoscopic Discectomy

Study	Length of stay (days)	Leg pain VAS	Lower back pain VAS	ODI	SF-36 PCS
Wang et al 201956,
N	90	90	90	90
Percutaneous transforaminal endoscopic discectomy	Postoperative: 3.01 ± 0.52	Preoperative mean score vs. 6 months after surgery: 7.21 vs. 1.05	Preoperative mean score vs 6 months after surgery: 6.40 vs. 1.36	Preoperative mean score vs 6 months after surgery: 58.21% vs. 17.05%
Microendoscopic discectomy	Postoperative: 6.68 ± 0.30	Preoperative mean score vs. 6 months after surgery: 7.09 vs. 0.98	Preoperative mean score vs 6 months after surgery: 6.34 vs. 1.65	Preoperative mean score vs 6 months after surgery: 57.17% vs. 16.98%
p	0.001	0.097	0.523	0.864
Gibson et al 201757,				2.6
N	140	140a	140a	140a	140a
Transforaminal endoscopic discectomy	0.7 ± 0.7	1.9 ± 2.6	2.5 ± 2.5	18 ± 17	47.7 ± 10.6
Microdiscectomy	1.4 ± 1.3	3.5 ± 3.1	3.0 ± 2.8	22 ± 20	47.4 ± 10.6
p	<0.001	0.001	0.45	0.15	0.69

ODI: Oswestry Disability Index; SF-36 PCS: Short-Form-36 Physical Component Score; VAS: visual analogue scale.

^aPostoperative patient-reported outcome measures at 2 years.

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-upe
Wang et al 201956,	3. Study population similar to other trials with regard to age, sex; however, included patients from a single Chinese hospital			1. Morbidity-related outcomes such as complication and reoperation rates were not reported	1,2. Outcomes reported only for 6 months of follow-up
Gibson et al 201757,	3. Study population similar to other trials with regard to age, sex; however, included patient from a single Scottish hospital	1. For transforaminal endoscopic discectomy, a different anesthetic technique was utilized that may have favored a shorter length of stay		1. Morbidity-related outcomes such as complication and reoperation rates were not reported

^aPopulation key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^bIntervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^cComparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^dOutcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^eFollow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
Wang et al 201956,	3.	1,2. Blinding did not appear to occur			1.
Gibson et al 201757,		1,2. Blinding did not appear to occur		6. Data analyzed "as treated" not as "intention-to-treat"	1.

^aAllocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^bBlinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^cSelective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^dData Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^ePower key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power
^fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Gotecha et al (2016) published a prospective study on the use of transforaminal PELD for the treatment of lumbar disc herniation.^58, Efficacy and limitations of the procedure were studied in 120 patients with lumbar disc herniation. Using McNab criteria, 89% achieved excellent (no pain or restrictions) or good (occasional back/leg pain) status at 6 months of follow-up. The authors noted a limitation of the procedure is that during surgery on patients with L5 through S1 lumbar disc herniation, the iliac crest may interfere with the angle necessary to perform a successful discectomy.

A number of observational studies have also assessed the learning curve^59,60,61, and the need for longer follow-up for endoscopic discectomy.^62,63, The largest and longest follow-up to date has been reported by Choi et al (2015), who examined 10,228 patients at their institution who had had PELD over a 12-year period.^64, They found that 4.3% of cases required reoperation in the first 6 weeks due to incomplete removal of herniated discs (2.8%), recurrence (0.8%), persistent pain (0.4%), and approach-related pain (0.2%).

Section Summary: Percutaneous Endoscopic Discectomy

The evidence for percutaneous endoscopic discectomy in individuals who have herniated intervertebral disc(s) includes a number of RCTs and systematic reviews. Many of the more recent RCTs are conducted at institutions within China. There are few reports from the United States. Overall, results from RCTs and systematic reviews reveal a significantly reduced length of hospitalization with endoscopic discectomy and occasionally significant improvements in VAS or ODI, but only at specific time points. No consistently significant improvement in VAS, ODI, total complication rate, reoperation, or recurrence was observed with percutaneous endoscopic discectomy versus other interventions. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc herniation causing lumbar radiculopathy according to clinical input expert opinion. However, respondents were mixed in the level of support of this indication, and overall there was not a preponderance of clinical input support in general cases. Further details from clinical input are included in the Clinical Input section later in the review and the Appendix.

Summary of Evidence

For individuals who have herniated intervertebral disc(s) who receive automated percutaneous discectomy, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The published evidence from small RCTs is insufficient to evaluate the impact of automated percutaneous discectomy on the net health outcome. Well-designed and executed RCTs are needed to determine the benefits and risks of this procedure. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis. However, the clinical input is not generally supportive of a clinically meaningful improvement in net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have herniated intervertebral disc(s) who receive percutaneous endoscopic discectomy, the evidence includes a number of RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Many of the more recent RCTs are conducted at institutions within China. There are few reports from the United States. Results do not reveal a consistently significant improvement in patient-reported outcomes and treatment-related morbidity with percutaneous endoscopic discectomy in comparison to other discectomy interventions. Clinical input suggests this intervention may be an appropriate treatment option for the highly selected patient who has a small focal disc herniation causing lumbar radiculopathy according to clinical input expert opinion. However, respondents were mixed in the level of support of this indication, and overall there was not a preponderance of clinical input support in general cases. The evidence is insufficient to determine the effects of the technology on health outcomes.

CLINICAL INPUT
Objective

In 2018, clinical input was sought to help determine whether the use of either automated percutaneous discectomy or percutaneous endoscopic discectomy for individuals with herniated intervertebral disc(s) would provide a clinically meaningful improvement in the net health outcome and whether the use is consistent with generally accepted medical practice.

Respondents

Clinical input was provided by the following specialty societies and physician members identified by a specialty society or clinical health system:

• American Association of Neurological Surgeons / Congress Neurological Surgeons (AANS/CNS) Joint Section on Disorders of the Spine and Peripheral Nerves
• North American Spine Society (NASS) & American Academy of Orthopaedic Surgeons (AAOS)
• Anonymous, MD, Neurosurgery, identified by an academic medical center

Clinical Input Responses
Additional Comments
Automated Percutaneous Discectomy

• "Automated percutaneous lumbar discectomy is an appropriate treatment option for the highly selected patient who has a small focal disc fragment compressing a lumbar nerve causing radiculopathy in the absence of lumbar stenosis or severe bony foraminal stenosis. The success rate is less than for traditional lumbar discectomy at 75%, and is less effective in patients with free fragments or stenosis. This procedure should be performed only by surgeons who are appropriately trained in both percutaneous and open lumbar surgery." (AANS/CNS)
• "There does not appear to be sufficient evidence to support the clinical use of automated percutaneous lumbar discectomy for individuals with herniated intervertebral disc(s)." (NASS & AAOS)
• "We don't use this technology or method at our institution and don't believe it is superior to alternative approaches." (Anonymous, Neurosurgery, identified by an academic medical center)

• "Percutaneous endoscopic discectomy is a treatment option for patients who have a small focal disc herniation causing lumbar radiculopathy. It utilizes an endoscope that is placed through an image guided approach. It is only appropriate for patients in whom the pathology can be approached through an interlaminar approach, as it does not allow for any significant bone removal. Again, it should only be performed by surgeons who are facile and appropriately trained in this technique as well as open lumbar surgery." (AANS/CNS)
• "Although some studies report longer operative times, higher complication rates, and additional time for providers' to learn the technique, there is sufficient evidence to support clinical efficacy for percutaneous endoscopic discectomy for individuals with herniated intervertebral disc(s). Well conducted studies show equivalent or superior results compared to open microdiscectomy in terms of surgery time, hospital stay, return to work, patient satisfaction, and short as well as long term clinical results." (NASS & AAOS)
• "We don't use this technology or method at our institution. We aren't convinced that it is superior to an open or MIS procedure involving use of the microscope." (Anonymous, Neurosurgery, identified by an academic medical center)

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.

2018 Input

In response to requests, clinical input on automated percutaneous discectomy and percutaneous endoscopic discectomy for herniated intervertebral disc(s) was received from 3 respondents, including 2 specialty society-level responses and including physicians with academic medical center affiliation, while this policy was under review in 2018.

Evidence from clinical input is integrated within the Rationale section summaries and the Summary of Evidence.

2013 Input

In response to requests, input was received from 4 physician specialty societies and 3 academic medical centers while this policy was under review in 2013. Overall, input agreed that percutaneous and endoscopic discectomy are investigational. Most reviewers considered discectomy with tubular retractors to be a variant of open discectomy, with the only difference being the type of retraction used.

Practice Guidelines and Position Statements
National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE; 2005) published guidance on automated percutaneous mechanical lumbar discectomy, indicating there was limited evidence of efficacy based on uncontrolled case series of heterogeneous groups of patients, and evidence from small RCTs showed conflicting results.^65, The guidance indicated that, in view of uncertainty about the efficacy of the procedure, it should not be done without special arrangements for consent and for audit or research. The guidance was considered for an update in 2009, but failed review criteria; the 2005 guidance is therefore considered current.

A NICE (2016) guidance on percutaneous transforaminal endoscopic lumbar discectomy for sciatica was published.^66, The guidance stated that current evidence is adequate to support the use of percutaneous transforaminal endoscopic lumbar discectomy for sciatica. Choice of operative procedure (open discectomy, microdiscectomy, or percutaneous endoscopic approaches) may be influenced by symptoms, location, and size of the prolapsed disc.

A NICE (2016) guidance on percutaneous interlaminar endoscopic lumbar discectomy for sciatica was also published.^67, The guidance stated that current evidence is adequate to support the use of percutaneous interlaminar endoscopic lumbar discectomy for sciatica. Choice of operative procedure (open discectomy, microdiscectomy, or percutaneous endoscopic approaches) may be influenced by symptoms, location, and size of the prolapsed disc.

American Society of Interventional Pain Physicians

The guidelines from the American Society of Interventional Pain Physicians (2013) indicated that the evidence for percutaneous disc decompression with the Dekompressor was limited.^3, There were no recommended indications for the Dekompressor.

North American Spine Society

The North American Spine Society (2014) published clinical guidelines on the diagnosis and treatment of lumbar disc herniation^68, Table 12 summarizes recommendations specific to percutaneous endoscopic discectomy and automated percutaneous discectomy.

Table 12. Recommendations for Lumbar Disc Herniation With Radiculopathy

Recommendations	Grade or LOEa
Endoscopic percutaneous discectomy is suggested for carefully selected patients to reduce early postoperative disability and reduce opioid use compared with open discectomy.	B
There is insufficient evidence to make a recommendation for or against the use of automated percutaneous discectomy compared with open discectomy.	I
Endoscopic percutaneous discectomy may be considered for treatment.	C
Automated percutaneous discectomy may be considered for treatment.	C
Patients undergoing percutaneous endoscopic discectomy experience better outcomes if <40 years and symptom duration <3 months.	II

LOE: level of evidence.

^a Grade B: fair evidence (level II or III studies with consistent findings; grade C: poor quality evidence (level IV or V studies). Level of evidence II: lesser quality randomized controlled trial (eg, <80% follow-up, no blinding, or improper randomization), prospective comparative study, systematic review of level II studies or level I studies with inconsistent results; level of evidence III: case control, retrospective, systematic review of level III studies; level of evidence IV: case series; level of evidence V: expert opinion.

The clinical practice guidelines from the American Pain Society (2009) found insufficient evidence to evaluate alternative surgical methods to standard open discectomy and microdiscectomy, including laser or endoscopic-assisted techniques, various percutaneous techniques, coblation nucleoplasty, or the Dekompressor.^69,

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Currently unpublished trials that might influence this policy are listed in Table 13.

Table 13. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT01997086	Percutaneous Transforaminal Endoscopic Discectomy (PTED) vs. Microendoscopic Discectomy (MED) for the treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study	125	Aug 2023
NCT02602093	(Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation (PTED-study)	682	Apr 2021
NCT02742311	EuroPainClinics® Study V Prospective Observational Study (EPCSV)	500	Dec 2020
Unpublished
NCT02441959	Full-Endoscopic vs Open Discectomy for the Treatment of Symptomatic Lumbar Herniated Disc: A Prospective Multi-Center Randomized Study	200	Jul 2018 (terminated)
NCT01622413a	Transforaminal Endoscopic Surgery Cost Outcome Research Trial(TESCORT)	0	Sep 2017 (withdrawn)
NCT02358291	Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation	240	Mar 2017(unknown)

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Automated Percutaneous and Percutaneous Endoscopic Discectomy
Automated Percutaneous and Endoscopic Discectomy
Discectomy, Percutaneous
Lumbar Discectomy, Percutaneous
Nucleotome
Percutaneous Discectomy
PLD
Stryker Dekompressor Percutaneous Discectomy Probe
SpineJet Hydrosurgery System
ArthroJet System
HydroCision ArthroJet System
Tubular Discectomy
Tubular Diskectomy
Endoscopic Discectomy

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

62287
62380