Medical Policy



Subject: Doppler-Guided Transanal Hemorrhoidal Dearterialization
Document #: SURG.00141 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

This document addresses transanal hemorrhoidal dearterialization (THD), a minimally invasive procedure utilizing Doppler guidance to interrupt the blood supply by ligation of the hemorrhoidal arteries in the lower rectum. Dearterialization by Doppler-guided transanal hemorrhoidal artery ligation is also known as HAL.

Position Statement

Investigational and Not Medically Necessary:

Doppler-guided transanal hemorrhoidal dearterialization is considered investigational and not medically necessary.

Rationale

THD interrupts blood circulation by ligating the hemorrhoidal artery in the lower rectum. The artery is located using Doppler equipment. Interrupting blood circulation to the hemorrhoidal artery contributes to shrinkage of the hemorrhoidal cushion and subsequently improves symptoms. Because the ligation is conducted above the dentate line, the pain-sensitive anoderm is preserved.

Elmer and colleagues (2013) compared the early and midterm results of THD with anopexy to open hemorrhoidectomy. A total of 40 participants with grade II to grade III hemorrhoids were randomized to THD with anopexy (group A, n=20) or open hemorrhoidectomy (group B, n=20). Participants kept a diary during the first 2 postoperative weeks to record pain scores. A self-reported symptom questionnaire was completed, and a clinical examination was performed preoperatively, after 2 to 4 months, and after 1 year. Postoperative pain was the primary outcome measure. During the first week, group A had less postoperative peak pain compared to group B (p<0.05), however there was no difference between the groups for overall pain (p=0.010). Analgesic use was not significantly different between the groups. After 1 year, there were significant improvements (p<0.05) in pain, bleeding, and the need for manual reduction of the hemorrhoids in both groups. The authors acknowledged that limitations of the study included the small sample size and the short follow-up period, the absence of blinding, use of an unvalidated, but frequently utilized questionnaire.

In 2011, Gupta reported data from a double-blind, randomized controlled trial involving 48 consecutive individuals requiring surgery for grade III hemorrhoids. The study endpoints were to determine if Doppler-assisted ligation of the hemorrhoid artery prior to mucopexy (DSL) was more advantageous to mucopexy alone (SL). Outcomes were measured by duration of the operation, postoperative morbidity, resolution of hemorrhoidal symptoms and medium-term recurrence rates. Surgery duration was significantly longer with DSL compared to SL (31 minutes [min] vs. 9 min.; p<0.003). The postoperative pain score was significantly higher for the DSL cohort compared to the SL group (4.4 vs. 2.2; p<0.002) on the visual analogue scale, and the DSL group used higher doses of analgesics for longer periods of time (p<0.01). Between the cohorts, there was no difference in the complication rate. At 1-year follow-up, there was no statistically significant difference in the rate of recurrence in either group. The authors concluded that Doppler-assisted ligation of the hemorrhoid artery did not add extra benefit compared to SL. Limitations of the study include single center, and medium duration of follow-up. Additional randomized controlled studies in multiple centers with long-term follow-up were recommended.

Festen and colleagues (2010) reported results from a randomized trial comparing the procedure for prolapse and hemorrhoids (PPH) and THD in the treatment of grade III and IV hemorrhoids. Subjects with grade III or IV hemorrhoids were randomly assigned to undergo PPH (n=18 individuals) or THD (n=23 individuals). The participants were evaluated postoperatively after 1 week, 3 weeks and 6 weeks. Resolved symptoms postoperatively at 6 weeks was the primary endpoint. Pain (measured by a visual analogue scale [VAS] after 1 day, 1 week and 3 weeks), and complications were the secondary endpoints. At 6 weeks postoperatively, the success rates were 83% in the PPH group versus 78% in the THD group. The VAS scores were significantly lower after 1 day and 1 week in the THD group, but were similar after 3 weeks. A total of 12% of the participants after PPH and 4% after THD required an urgent readmission to treat an acute bleeding. Overall, the rate of complications did not differ significantly between the two groups. The authors concluded for grade III and IV hemorrhoids, both PPH and THD are safe interventions with good short-term results and acceptable complication rates. Because the complication rates and short-term results were similar, but less postoperative pain when compared to PPH, THD might be preferred by some. However, the authors noted these preliminary outcomes needed to be validated in larger randomized studies with longer follow-up in order to identify selection criteria.

Ratto and colleagues (2010) performed a retrospective analysis of 170 individuals treated at a single institution with THD from July 2005 through October 2008. Individuals with grade I hemorrhoids were excluded. For individuals with grade II hemorrhoids, enrollment criteria included presentation with significant bleeding and/or prolapse and failure of medical therapy. The procedure involved dearterialization of six arteries in all of the participants, with major mucopexy in 56 subjects (32.9%). General/spinal anesthesia was utilized to treat the first consecutive 11 subjects (6.4%) while sedation with propofol with remifentanil analgesia support was used for the remaining 159 (93.6%) subjects. Participants were evaluated at 2 weeks, 1 and 3 months, and once a year after THD. The mean follow-up period was 11.5 ± 12 (range, 1-41) months. A total of 13 (7.6%) of the participants had grade II hemorrhoidal disease, 141 (82.7%) had grade III disease and 16 (9.6%) had grade IV disease. Surgical intervention for postoperative bleeding was required for 2 cases (1.2%) and hemorrhoidal thrombosis occurred in 4 of the cases (2.3%). There were no cases of chronic pain or fecal incontinence reported. Continued constipation was reported in 49 (28.8%) participants. A total of 50 participants (29.5%) reported hemorrhoidal prolapse at follow-up, but prolapse was confirmed in only 18 (10.5%) and the prolapse was mild. During the follow-up period, 7 subjects (4.1%) required surgery for recurrence of hemorrhoidal disease. The authors concluded that THD appears to be an effective minimally invasive option to treat hemorrhoids and can be carried out in a day-surgery setting. The authors also noted additional controlled trials comparing THD with other procedures are needed to demonstrate the efficacy of the procedure and to define appropriate selection criteria.

Giordano and colleagues (2009) conducted a systematic review to assess the current evidence on dearterialization, ascertain the safety and efficacy of the technique, define its indications, and pinpoint its possible advantages and limitations. The primary outcome measures were hemorrhoidal recurrences and postoperative pain. A total of 17 articles (involving 1996 individuals) were analyzed. Overall, the quality of the studies was low. Most of the subjects experienced a 1-day hospital stay and returned to normal activities within a range of 2-3 days. Approximately 18.5% of the subjects experienced postoperative pain. A total of 3 participants experienced significant postoperative hemorrhages. No other major complications were reported. The overall recurrence rate was 9.0% for prolapse, 4.7% for pain at defecation and 7.8% for bleeding. At 1 year or more follow-up, the recurrence rate was 10.8% for prolapse, 9.7% for bleeding, and 8.7% for pain at defecation. When the results were examined based on hemorrhoidal grade, the recurrence rate was higher for grade IV hemorrhoids (range, 11.1-59.3%). The authors concluded that THD appears to be a potential treatment option for grade II and III hemorrhoids. However, the authors also noted clinical trials with longer follow-up comparing THD to other established procedures used to treat hemorrhoids are needed to determine the possible role of the procedure.

In 2015, Ratto and colleagues described an observational Italian multi-center study consisting of 803 subjects with Grade II (n=137), III (n=548) and IV (n=118) symptomatic hemorrhoids treated using THD. Those with prolapse also underwent rectal mucopexy. Disease was assessed by a specifically designed symptom questionnaire and scoring system. Treatment failure was defined as the presence of recurrent bleeding or recurrent hemorrhoidal prolapse needing medical or surgical therapy. The overall success rate after a follow-up of less than 12 months was 90.7%. Analysis of subjects with a follow-up of 12 months or greater demonstrated a lower success rate of 86.9%. The authors reported that it is necessary to be very careful to avoid complications as this could affect the long-term outcome. Limitations included the observational nature of the study.

A large systemic review and meta-analysis performed by Simillis and colleagues (2015) compared 98 trials consisting of 7827 subjects and 11 surgical treatments for grade III and IV hemorrhoids. Treatments included open, closed and radiofrequency hemorrhoidectomies, sub-mucosal hemorrhoidectomy, stapled hemorrhoidectomy, THD, Ligasure and Harmonic® procedures, laser hemorrhoidectomy, Starion hemorrhoidectomy, and bipolar scissors hemorrhoidectomy. Although some benefits were noted as a result of THD, it also had a higher recurrence rate than open, closed, Ligasure, laser and radiofrequency hemorrhoidectomies, and "importantly, the highest probability of being the worst treatment for recurrence of hemorrhoids (P=0.785)." The authors concluded that further higher quality RCT's are needed to compare surgical treatment for hemorrhoids.

According to the American Society of Colon and Rectal Surgeons (ASCRS; Rivadeneira, 2011):

Doppler-guided/assisted hemorrhoidal ligation is a procedure that uses an anoscope fashioned with a Doppler probe for identification of each hemorrhoid arterial blood supply that is subsequently ligated. A potential benefit is the lack of tissue excised and possibly less pain. Currently, larger studies including variations of the Doppler technique and comparisons with other methods with longer follow-up intervals are required before definitive recommendations on this method.

According to the American College of Gastroenterology (ACG; Wald, 2014), THD has the potential comparative benefit of excising less tissue, but may not address "The problem of redundancy, as well as other operations. Success rates are comparable to those reported for both hemorrhoidectomy and stapled hemorrhoidopexy, although there have yet to be comparative studies."

THD appears to be a promising, less invasive treatment option for symptomatic internal hemorrhoids. There are published reviews, retrospective case series and several studies of THD and THD in combination with procedures for prolapsed hemorrhoid (PPH). THD has demonstrated encouraging, but mixed results in terms of pain, operation time and complications. Larger, multicenter studies comparing THD with the gold standard procedures used to treat symptomatic hemorrhoids and longer follow-up are needed to establish a possible role for this technique and to identify selection criteria.

Background/Overview

Hemorrhoids are amongst the most common anorectal complaints. It has been estimated that approximately 10-20% of individuals with symptomatic hemorrhoids require surgery. Hemorrhoidal symptoms vary and may include painless rectal bleeding, tissue protrusion and drainage of mucous. The traditional therapeutic strategies to treat hemorrhoids include surgical as well as nonsurgical treatment. Nonsurgical interventions may include ensuring adequate fluid intake, increasing dietary fiber, avoiding straining with defecation, rectal suppositories and Sitz baths. Other conservative interventions such as infrared photocoagulation, injection sclerotherapy and rubber band ligation have been used to fixate the hemorrhoid's cushion. If conservative interventions are ineffective, surgical treatments may be used.

The conventional hemorrhoidectomy is accepted by most surgeons as the gold standard for the treatment of hemorrhoids that have not responded to conservative management. Milligan-Morgan's and Ferguson's procedures are the most commonly used surgical techniques. Although these techniques tend to yield excellent results and tend to have low complication rates, they are usually associated with significant postoperative pain. In order to reduce pain, alternative procedures including but not limited to THD, are being explored.

In 2008, the U.S. Food and Drug Administration (FDA) issued a 510K approval for the THD Slide system (S.p.a Medical Division, Correggio, Italy; THD America, Inc., Natick, MA). The approved indication for the THD Slide Doppler-guided proctoscope system was for the surgical treatment of second and third degree hemorrhoids. The approval was based on predicate devices with similar acoustic emissions.

Definitions

Classification of Internal Hemorrhoids:

Grade I       Prominent hemorrhoidal vessels, no prolapse
Grade II      Prolapse with Valsalva and spontaneous reduction
Grade III     Prolapse with Valsalva requires manual reduction
Grade IV    Chronically prolapsed manual reduction ineffective

Ligation: A procedure where a structure is bound or tied.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the following procedure code or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
0249T Ligation, hemorrhoidal vascular bundle(s), including ultrasound guidance
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014; 57(3):348-353.
  2. Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013; 56(4):484-490.
  3. Festen S, van Hoogsraten MJ, van Geloven AA, Gerhards MF. Treatment of grade III and IV haemorrhoidal disease with PPH or THD. A randomized trial on postoperative complications and short-term results. Int J Colorectal Dis. 2009; 24(12):1401-1405.
  4. Giamundo P, Salfi R, Geraci M, et al. The hemorrhoid laser procedure technique vs rubber band ligation: a randomized trial comparing 2 mini-invasive treatments for second- and third-degree hemorrhoids. Dis Colon Rectum. 2011; 54(6):693-698.
  5. Giordano P, Overton J, Madeddu F, et al. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum. 2009; 52(9):1665-1671.
  6. Gupta PJ, Kalaskar S, Taori S, Heda PS. Doppler-guided hemorrhoidal artery ligation does not offer any advantage over suture ligation of grade 3 symptomatic hemorrhoids. Tech Coloproctol. 2011; 15(4):439-444.
  7. Pucher P, Sodergren M, Lord A, et al. Clinical outcome following Doppler-guided haemorrhoidal artery ligation: a systematic review. Colorectal Dis. 2013; 15(6):e284-e294.
  8. Ratto C, Donisi L, Parello A, et al. Evaluation of transanal hemorrhoidal dearterialization as a minimally invasive therapeutic approach to hemorrhoids. Dis Colon Rectum 2010; 53(5):803-811.
  9. Ratto C, Parello A, Veronese E, et al. Doppler-guided transanal haemorrhoidal dearterialization for haemorrhoids: results from a multicentre trial. Colorectal Dis. 2015; 17(1):10-19.
  10. Schuurman J, Borel Rinkes I, Go P. Hemorrhoidal artery ligation procedure with or without Doppler transducer in grade II and III hemorrhoidal disease: a blinded randomized clinical trial. Ann Surg. 2012; 255(5):840-845.
  11. Simillis C, Thoukididou SN, Slesser AA, et al. Systematic review and network meta-analysis comparing clinical outcomes and effectiveness of surgical treatments for haemorrhoids. Br J Surg. 2015; 102(13):1603-1618.
  12. Zampieri N, Castellani R, Andreoli R, Geccherle A. Long-term results and quality of life in patients treated with hemorrhoidectomy using two different techniques: Ligasure versus transanal hemorrhoidal dearterialization. Am J Surg. 2012; 204(5):684-688.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Rivadeneira DE, Steele SR, Ternent C, et al. Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of hemorrhoids (revised 2010). Dis Colon Rectum. 2011; 54(9):1059-1064.
  2. U.S. Food and Drug Administration 510(k) Premarket Notification Database. THD Slide. No. K081429. Rockville, MD: FDA. May 16, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081429.pdf. Accessed on June 7, 2017.
  3. Wald A, Bharucha AE, Cosman BC, Whitehead WE. Clinical Guideline: Management of Benign Anorectal Disorders. Am J Gastroenterol. 2014; 109(8):1141-1157.
Websites for Additional Information
  1. U.S. National Library of Medicine. Hemorrhoids. Reviewed October 12, 2016. Available at: http://www.nlm.nih.gov/medlineplus/hemorrhoids.html. Accessed on June 7, 2017.
Index

Transanal hemorrhoidal dearterialization (THD)
Transanal hemorrhoidal artery ligation (HAL)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale and References sections updated.
Reviewed 08/04/2016 MPTAC review. References updated. Removed ICD-9 codes from Coding section.
New 08/06/2015 MPTAC review. Initial document development.