Informing procurement – Encouraging innovation

Evidence review

Electrosurgical vessel sealing in vaginal hysterectomy

CEP 07019

November 2007

Contents 2

CEP 07019: 2007

Summary 3

Introduction 4

Methods 6

Evidence review 8

Economic analysis 13

Conclusions 17

Acknowledgements 18

References 19

Appendix 1: Literature search strategy 21

Appendix 2: Recording expert opinion 22

Appendix 3: Expert opinion 24

Appendix 4: Glossary 25

Appendix 5: Product details 26

Appendix 6: Supplier details 27

Author and report information 28

Summary 3

CEP 07019: 2007

The product Electrosurgical vessel sealing (ESVS) systems have been developed to seal large tissue bundles and blood vessels, up to 7 mm diameter for some models. Specialist bipolar forceps are available for a range of laparoscopic and open surgical procedures. The technology was pioneered by Valleylab in the 1990s, primarily for use in laparoscopy. More recently several manufacturers have produced similar systems that are available in the UK.

Field of use The use of ESVS during the removal of the uterus and ovaries (hysterectomy) in women for benign conditions is the focus of this evidence review. Currently, around 70 – 90 % of hysterectomies in the UK are carried out via abdominal incision. This report examines the potential for ESVS to facilitate vaginal hysterectomy in a larger proportion of cases and assesses the clinical and financial consequences.

National guidance NICE guidelines on heavy menstrual bleeding published in January 2007 advise that “taking into account the need for individual assessment, the route of hysterectomy should be considered in the following order: first line vaginal; second line abdominal“ [1]. This advice was based on the recent Cochrane review [2] of the surgical approach to hysterectomy for benign gynaecological disease which found that women who had vaginal hysterectomy had a shorter hospital stay, quicker return to normal activities and fewer unspecified febrile episodes when compared with those who had abdominal hysterectomy.

Evidence reviewed Six published trials on the use of ESVS in vaginal hysterectomy were reviewed and the opinions of UK consultant gynaecology surgeons with relevant ESVS experience was also sought. This report concentrates on clinical factors and issues relating to costs. The data are used to assess the economic impact of ESVS on NHS costs for hysterectomy.

CEP’s verdict – Significant potential ESVS enables surgeons to undertake difficult cases using vaginal hysterectomy, reduces operation time and patients report less pain. Fewer sutures are required and some surgeons have been able to reduce the length of stay for vaginal hysterectomy, typically by one day.

ESVS equipment can be cost-effective due to savings accrued from reduced length of stay.

Investing in this new technology has the potential to make the transition from abdominal to vaginal hysterectomy easier and economically viable. Further independent studies are needed to establish the clinical effectiveness of the newer ESVS systems and forceps for vaginal hysterectomy.

Introduction 4

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Current clinical practice Approximately 50,000 hysterectomies are carried out in the UK each year [3-5]. The current NHS National Tariff (HRG code MO7) for elective vaginal or abdominal hysterectomy is £2,633 [6]. Hysterectomies therefore represent approximately £131 million per annum in income for NHS trusts across the UK.

Four different approaches to the surgical removal of the uterus are possible: through a single incision in the abdomen (abdominal hysterectomy, AH); surgical access solely through the vagina (vaginal hysterectomy, VH); “keyhole surgery” using several incisions and the use of laparoscopic surgical tools (laparoscopic hysterectomy, LH); and a combination of the last two called laparoscopically assisted vaginal hysterectomy (LAVH).

A Cochrane review on the surgical approach to hysterectomy for benign gynaecological disease, published in 2006, concluded that vaginal hysterectomy should be performed in preference to abdominal hysterectomy, where possible. If vaginal hysterectomy is not possible, a laparoscopic approach may avoid the need for an abdominal hysterectomy [2]. This conclusion was endorsed in the NICE guidelines on heavy menstrual bleeding [1].

The Cochrane review [2] of 27 randomised controlled trials found that VH meant a shorter stay in hospital compared with AH (weighted mean difference 1.0 day, 95% confidence interval 0.7 to 1.2 days); a speedier return to normal activities for the patient (WMD 9.5 day, 95%CI 6.4 to 12.6 days) and fewer unspecified infections or febrile episodes (WMD 0.42, 95% CI 0.21 to 8.3). Laparoscopic hysterectomy required a longer operating time and resulted in more urinary tract injuries compared with AH and so the authors considered that these outweighed the LH benefits of lower inter-operative blood loss, shorter hospital stay and speedier return to normal activities. There was no evidence of benefits for LH compared with VH and the operating time was increased for LH. The authors also commented that further research is needed to assess the longer term outcomes of all these operative techniques and for newer approaches to hysterectomy to be evaluated [7].

Currently there appears to be widespread reluctance by surgeons to use the vaginal approach for the majority of their patients who require hysterectomy for benign disease. It is recognised that vaginal hysterectomy solely using sutures is a more technically challenging surgical technique. Whilst, in some studies, authors report changing their clinical practice to achieve between 60% and 100% of cases being accessed via the vaginal route [8 -12] most hysterectomies in the UK are abdominal (70-90%) [3, 13]. Only 10-30% of cases are performed as vaginal hysterectomies and less than 5% are laparoscopic or laparoscopically assisted vaginal hysterectomies.

This report examines whether investing in new technology – electrosurgical vessel sealing – can make the transition from abdominal to vaginal hysterectomy easier and economically viable.

Introduction 5

CEP 07019: 2007

Electrosurgical vessel sealing (ESVS) technology This technology represents an alternative to traditional suturing and stapling and has been developed by manufacturers of electrosurgical (surgical diathermy) equipment primarily for use during endoscopy. Traditional electrosurgical generators and standard bipolar forceps, in use for over 100 years, use radiofrequency electrical current to heat and coagulate vessels but only adequately seal vessels up to 2mm diameter [14].

Vessel sealing of larger vessels is achieved by combining two advances in electrosurgical generator technology with specifically designed and manufactured mechanical forceps. The three factors required to achieve adequate sealing of larger vessels and tissue bundles are:

• Electrosurgical output - This is bipolar but at a higher current compared with conventional bipolar

• Electrosurgical generator - The seal is achieved using a closed feedback loop to monitor the effect of the current on the tissue by measuring tissue impedance. The feedback loop algorithms are therefore important to ensure an adequate seal. Different generator models will not use the same algorithm or tissue impedance value as the surgical endpoint. These differences may give rise to some variability between different generator models that may affect the seal quality, thermal spread and surgical outcome which can only be assessed by comparative studies and clinical trials. However, vessel sealing is not a technology that can be left to the surgeon to decide when to turn off the current as this will introduce even greater variability in performance

• Forceps - These are usually manufactured to achieve a particular pressure across the jaws and therefore only encompass a certain amount of tissue. The jaw distance is manufactured to a specific tolerance and an adequate seal depends on appropriate jaw pressure. The pressure is much higher and more evenly applied than can be achieved using standard bipolar forceps

Some designs of electrosurgical vessel sealing systems have been demonstrated to achieve complete haemostasis in larger tissue bundles and blood vessels (up to 7 mm in diameter) [15]. Variations in the design of any one of these three factors can affect the surgical outcome. For example, using the same forceps different vessel sealing surgical results can be obtained depending on the generator used. The Triad™ feedback loop is faster and impedance calculations are performed in real time compared with the Ligasure™ which uses a slower sample rate and retrospective calculation of the next energy pulse.

Some ESVS forceps also incorporate cutting blades.

Methods 6

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We have reviewed the literature (Medline and Embase) for clinical studies comparing vaginal hysterectomy using electrosurgical vessel sealing systems (VHESVS) with vaginal hysterectomy using traditional suturing for haemostasis (VHsuture) as described in Appendix 1.

We identified six published studies which evaluated the use of ESVS technology in vaginal hysterectomy. Three are randomised controlled trials (RCTs) comparing ESVS with traditional suturing [16-18]. Others are: a prospective, unrandomised comparison between similar patient groups [19]; an observational comparison between recent cases of vaginal hysterectomy using ESVS with earlier cases where only suturing was used [20]; a mixed study [21]. Only the largest RCT provided statistical analysis of complication rates [17].

Selection concentrated on those studies that included vaginal hysterectomy, related to normal sample populations, and provided information on clinical outcomes, hospital costs or on outcomes impacting on this.

We also collated the opinion of five UK experts with experience of ESVS and/or traditional suturing in vaginal hysterectomy by semi-structured telephone interviews, recording the data on summary data sheets (see Appendix 2). As there have been no published economic evaluations assessing the use of bipolar ESVS clamps in vaginal hysterectomy this information was important for: validating the published studies; determining the key resource factors which differed for the various operative approaches; obtaining cost related data for the economic analysis. Comparable information on abdominal hysterectomy was also documented, so the potential cost implications to the NHS of increasing the uptake of VH by the purchase of ESVS products could be estimated.

Laparoscopic hysterectomy was excluded from this analysis as it is performed infrequently and other studies have already established that LAVH and LH are more expensive than both VH and AH [13, 22], require a longer operating time and are associated with more urinary tract injuries compared with AH [7].

Limitations of study Many ESVS products included in this report are new to the market so there are no published studies describing their clinical effectiveness.

The majority of VHs are undertaken for cases of genital prolapse [13]. Studies which are not randomised controlled trials (RCTs) are likely to be biased, as VH may be carried out for simpler surgical cases in older women [13, 23] which would bias results as the uterus has a lower blood supply after the menopause. Three published studies reviewed in this report were RCTs [16-18] and the other three studies have tried to compensate for this bias by careful selection of patients [19-21].

On reviewing the literature and in discussions with UK experts we found that the variation in factors influencing cost was greater within each surgical approach than between approaches. This indicates that surgical experience, case mix and local policy can have a greater impact on resource use than choice of surgical approach. For example local policies on bed management can have a greater impact on resource usage than the surgical approach used.

Methods 7

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Hospital costs There were no published papers analysing costs of ESVS compared with sutures alone in vaginal hysterectomy. Consequently, in this report, cost data has been derived from the activity data obtained from six relevant research papers and expert opinion, together with ESVS costs from the manufacturers (see Table 7) and resource costs obtained from national and local sources (see Table 8).

Operation time Results for the duration of the surgical procedure were reported as ‘anaesthesia time’, ‘surgery time’ or were unspecified. Only RCTs were used in the comparison table (Table 6).

Complication rates Comparing and pooling data on clinical complications is difficult because their definitions varied or were not described. The complication rates for individual sequelae are very small and patients may also be affected by more than one complication.

Evidence review 8

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ESVS surgical technique

Vaginal surgery in a non-prolapsed uterus is difficult, particularly when it is enlarged by fibroids or fixed by adhesions from prior Caesarean sections or abdominal surgery. Placing sutures on distant pedicles deep in the pelvis is a significant challenge for the majority of gynaecologists. Reliable vessel sealing with ESVS reduces haemorrhage and “facilitates safety and haemostasis in situations of difficult access” [20]. Space requirements are less for ESVS than when suturing via the vaginal route [19] because fewer instruments need to be used simultaneously, so excessive traction on the pelvic organs is avoided [21]. ESVS also facilitates the vaginal approach when patients have a narrow vagina or an immobile uterus [21]. In addition, many surgeons will not contemplate vaginal oophorectomy (removal of the ovaries) at the time of hysterectomy and the use of ESVS may facilitate this operation in less experienced hands.

ESVS is easy to learn and does not require any extra skills [20], but a training period with a surgeon experienced in ESVS technology and the technique is advised. ESVS is also safer for the surgeon as the risk of needle-stick injuries is significantly reduced. Hefni et al [17] consider the effective use of ESVS is largely “operator independent”, in contrast to suturing in vaginal hysterectomy, which requires high levels of skill and dexterity. In summary, ESVS “should permit the less experienced vaginal surgeon the opportunity to expand the indications for vaginal hysterectomy” [18].

Operation time

Significant reductions in procedure time when using ESVS was found in the three RCTs [16-18] (see Table 1) and it was a common finding in the other studies (Table 2). Wide variations in operating times in Tables 1 and 3 reflect the variability in local procedural, surgeon and patient factors which also influence the operation time.

Table 1 Operating Time (minutes) – comparative data from randomised controlled trials

Published Reference

Vaginal Hysterectomy using sutures (minutes)

Vaginal Hysterectomy using ESVS (minutes)

No. of hysterectomies in study (sutures : ESVS)

[16] 40 32 (31:37) [17] 61 30 (59:57) [18] 60 48 (30:30)

Evidence review 9

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Table 2 – Summary of papers comparing use of ESVS with sutures in vaginal hysterectomy.

Reference Methods Results Limitations Notes

Clavé et al, 2005 [21]

Paper describing first 152 patients operated on with ESVS. 25 of these randomly compared to 25 traditional VH

• Pain score and use of morphine significantly reduced in ESVS group versus sutures (RCT)

• Standard hospital stay reduced from 6 days to 1 day in response to surgical and patient outcome experience

Anaesthesia protocol differed between groups. Complications not attributed to patient groups. Randomisation protocol not described

ERBE BiClamp. Patients in the ESVS group had locoregional anaesthesia

Cronjé and de Coning, 2005 [16]

RCT. Thirty-seven patients in ESVS group vs. 31 in suture group

• Operation time reduced in ESVS group (32 vs 40 mins)

• Sutures are reduced (1 vs 7) • Pain score significantly

reduced for ESVS group • Hospital stay (2 days) and

blood loss not different

Small sample sizes. Oophorectomy not performed in any patient

Valleylab LigaSure™. Private practice in South Africa. No complications occurred

Ding et al, 2005 [20]

Observational study. Thirty-two patients in ESVS group vs. previous 12 patients in suture/standard diathermy group

• Operation time reduced in ESVS group (30 vs 61 mins)

• Blood loss reduced in ESVS group (39 vs 206 ml)

• Hospital stay reduced in ESVS group (1.2 vs 3 days)

Small, unmatched sample groups. More oophorectomies carried out in ESVS group

Valleylab LigaSure™. No post-operative complications occurred

Hefni et al, 2005 [17]

RCT. Fifty-seven patients in ESVS group vs. 59 in suture group

• Operation time reduced in ESVS group (57 vs. 66 mins)

• Blood loss not different • Pain score reduced in ESVS

(4 vs 6) • 1 unintended skin burn in

ESVS group • 4 ‘haemorrhagic

complications’ in suture group

Complication rates too small for statistical analysis

Valleylab LigaSure™. Private UK hospital. Peri-operative injuries unrelated to haemostasis method. Similar percentage of oophorectomies (~ 39%) in both groups

Levy and Emery, 2003 [18]

RCT. Thirty patients each in ESVS and suture groups

• VH operation time reduced in ESVS group (39 vs 54 mins)

• Blood loss reduced in ESVS group (69 vs 127 ml)

• Hospital stay reduced in ESVS group (0.1 vs. 0.3 day) • Two complications in ESVS

and 3 in the suture group, but not statistically significant

No diagnosis information. Most VH surgery performed as outpatient service unless patients are elderly, have medical problems or home was isolated

Valleylab LigaSure™ Outpatient surgery. Operation time for ‘VH only’ and ‘total’ (incl. additional procedures) was reduced for the ESVS group

Zubke et al, 2004 [19]

Prospective, non-randomised. Forty patients each in ESVS and suture groups

• Reduced blood loss in ESVS group

• Reduced pain medication in ESVS group • Reduced hospital stay in

ESVS (5.8 vs 7.1 days for VH alone) and (6.6 vs 7.4 days for all VH cases including pelvic floor repair).

Patient groups similar. Results are only statistically significant for cases undergoing VH alone

ERBE BiClamp™ .

Evidence review 10

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Hospital stay

ESVS reduced patient stay in two of the three randomised control trials (Table 3) [17-18] but Table 2 reveals considerable differences in the post-operative stay experienced in different hospitals. This is largely due to local cultural, surgeon and patient expectations and no study explicitly defined their discharge criteria.

A hospital in the USA, having already established vaginal hysterectomy as an outpatient procedure, found that ESVS further reduced the time to patient discharge [18]. By contrast, Zubke et al working in Germany reported the average hospital stay reduced from 7.1 to 5.6 days following their use of ESVS for vaginal hysterectomy [19].

Two studies have been able to establish a 24 hr surgery service as a result of introducing ESVS for vaginal hysterectomy [20-21]. In their observational study surgeons in France found that early in their use of ESVS the hospital stay was 6 days, which they initially reduced to an average stay of 4.1 days. Although they had hoped to establish VHESVS as an outpatient service Clavé et al found organisational and social issues prevented this [21]. Now most of their patients undergoing VHESVS have a standard hospital stay of 1 day as their patients are routinely admitted a short time before the surgical procedure and are reassured by spending the first postoperative night in a monitored environment.

Table 3 Hospital inpatient stay (days) – Randomised control trials

Published Reference

Vaginal Hysterectomy

(sutures)

Vaginal Hysterectomy (using ESVS)

No. of hysterectomies in study

(sutures : ESVS)

[16] 2 2 (31:37) [17] 3 1.2 (59:57) [18] 0.3 0.1 (30:30)

Note: the criteria for discharge were not stated in these published studies

Complication rates

Overall the complication rates from using ESVS were either the same or slightly reduced when compared with using sutures in vaginal hysterectomy (Table 2) but most studies had small patient numbers and the data did not achieve statistical significance.

Accidental damage to the urinary tract or intestinal tract can cause severe post-operative complications but none were reported in these six studies. One RCT and an observational study reported no complications in either group [16, 20] and two studies described a variety of minor problems which appeared unrelated to the operative technique [17, 21]. Minimal blood loss is particularly desirable in patients undergoing hysterectomy for benign conditions

Evidence review 11

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as they often suffer from anaemia and iron deficiency. Blood loss was usually lower for ESVS patients but only reached statistical significance in two studies [18, 20], as determined by changes in the haemoglobin level and the surgeons’ estimate of the volume lost during the procedure. No difference was found in two RCTs [16-17], which the surgeons attributed to having already established a good surgical technique using sutures [17].

Two studies reported minor skin burns in the ESVS group early in their experience of ESVS which led to them taking greater care when manoeuvring the instrument [17, 21].

Post-operative re-bleeding in the ESVS group was rare. One ESVS patient was readmitted 12 days post-operatively for new onset vaginal bleeding [19]. Although this complication usually occurs in 1-2% of cases it prompted Zubke et al to revise the ESVS generator settings in subsequent cases to achieve a “more continuous transition zone from necrotic to healthy tissue”.

Post operative bleeding can also result from (a) ignoring the “failed seal” tone given by the generator; (b) attempting to seal a calcified artery or (c) attempting to seal tissues with a relatively low amount of collagen. For example, while some ESVS devices may seal 7mm arteries the size limit for vein sealing should be lower as the walls contain less collagen.

Re-bleeding was more commonly associated with sutures. Three cases of secondary bleeding along the vaginal suture line were reported [21], but these problems were resolved by changing the suture material. Two “suture cases” required abdominal hysterectomy to treat the bleeding [17]. This equates to an intra-operative conversion rate of 3.33% for vaginal hysterectomy using sutures alone, similar to that reported in the multi-centre EVALUATE study [22]. No conversions were reported for vaginal hysterectomies performed using ESVS.

Pain and patient recovery

Reduced pain for ESVS patients was reported as statistically significant in four studies [16-17, 19, 21], including two randomised controlled trials. This could be related to several factors: (a) dissection of the pedicles using ESVS may require less manipulation, compression and traction than when using sutures; (b) no foreign material (eg sutures or clips) being left in the pelvic cavity; (c) tissue left distal to the suture or clip (including nerves) can necrose post-operatively and may cause pain and infection.

The approach to anaesthesia and pain relief was not consistent across these reported studies, even amongst those centres that that have adopted 24 hour or outpatient vaginal hysterectomy. Clavé et al describe how using a loco-regional anaesthetic with a long term effect avoided the need for patient controlled morphine, with its associated deleterious effect on the lungs, and urinary and digestive systems [21]. They found this contributed to the patients’ post-operative well-being, avoided pre-, peri- and post-operative catheterisation and enabled the patient to resume normal feeding and use of the toilet as soon as they desired. Penketh et al avoid the use of patient controlled morphine analgesia, which can extend hospitalisation, by using a combination of spinal analgesia and sedation or a general anaesthetic, coupled with post-operative multimodal rectal and oral analgesia [12].

Evidence review 12

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Summary Table 4 Summary of studies comparing vaginal hysterectomy using ESVS with sutures alone

Issue Summary of published evidence

Surgical technique ESVS makes difficult vaginal procedures easier to perform

Operation time ESVS significantly reduces the time taken to perform vaginal hysterectomy

Complication rates No significant differences are reported in published papers but ESVS should be used with care to avoid inadvertent burns

Patient benefit Less pain, possibly related to reduced use of sutures

Hospital stay ESVS can reduce hospital stay and facilitate 24 hour surgery

Economic analysis 13

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Key differences affecting resource usage and cost Published data (see Table 2) and the opinions of five expert NHS surgeons experienced in VHESVS or VHsuture (see Appendix 3) was used to identify the key cost variables between vaginal hysterectomy using sutures and vaginal hysterectomy using ESVS.

Patient stay Three published RCTs evaluating VHESVS and VHsuture all report that reduced hospital stay is possible when ESVS is used in vaginal hysterectomy (Table 4) but huge variations exist, largely influenced by the expectations of the surgeon and patient. The three UK experts working in the NHS report a more consistent pattern, with hospital stay for VHsuture being 2-3 days compared with 2 days or less for VHESVS. One surgeon provided VHsuture as a 24 hour surgical service (Table 5).

Table 5 Hospital inpatient stay (days) – Opinion of expert gynaecology surgeons in UK

Expert Vaginal

Hysterectomy (sutures)

Vaginal Hysterectomy (using ESVS)

No. of hysterectomies performed by each consultant

surgeon every year

A 2 1 30 B 2 2 32 C 3 1.5-2 150

Operation time Reduced operating time for VHESVS compared with VHsuture is a consistent finding in both the published studies (see Table 1) and for our UK experts (Table 6). Unfortunately this rarely translates into cost savings as patient preparation and recovery time is unaltered and most theatre schedules are of fixed duration in the UK (usually 3.5 hours). Consequently this factor has not been incorporated in this economic assessment.

Table 6 Operating Time (minutes) – Opinion of expert gynaecology surgeons in UK

Expert Vaginal Hysterectomy (using sutures)

Vaginal Hysterectomy (using ESVS)

Patients per operating session

(3.5 hours / 210 mins)

C 40 15-20 3 D 40 30 5 (7 hour session) E 45 30 5

Sutures VHESVS patients should only require one suture for closing the vaginal vault, a saving of approximately 6 sutures per case [16], see Table 2. Use of other surgical consumables are largely unaffected by the surgical approach.

Economic analysis 14

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Medication Reduced pain is commonly associated with VHESVS (see Table 2) and can result in reduced use of morphine [19, 21] though our UK experts did not confirm this finding. They reported that inpatient pain relief for VH is usually determined by the anaesthetist’s assessment and patient choice so can be variable and is excluded from our cost comparison.

Complications Overall the complication rates reported in the published studies comparing VHESVS with VHsuture and those found by our experts were not significantly different so we have not included any resource use consequences in this economic analysis. Intra-operative conversion from vaginal to abdominal hysterectomy was reported for VHsuture [17], probably due to difficulties during the procedure or uncontrolled bleeding. This could be an important additional factor in the overall cost assessment if confirmed by larger studies.

Electrosurgical vessel sealing equipment In this economic assessment we assume that an electrosurgical (surgical diathermy) generator with an ESVS capability and the associated ESVS forceps/applicators [15] will need to be purchased. Five manufacturers currently market ESVS systems in the UK and prices vary considerably (see Appendix 5). Where a manufacturer recommends an applicator for vaginal hysterectomy this is listed in Appendix 5, otherwise a curved/angled instrument approximately 28 cm long has been selected [18]. The costs used in the economic analysis are summarised in Tables 7 and 8.

Table 7 ESVS costs (ex VAT) used in the economic comparison between VHESVS and VHsuture.

Manufacturer ESVS system

Generator

Reusable handpiece (product code)

Single use forceps or electrode

Comments

BOWA, Arc 350

£9,500 £825 (760-028)

£70 General purpose generator Reusable clamps (200 uses) with single

use electrodes ERBE, VIO & Biclamp upgrade

£12,455 £559 (270C)

- General purpose generator. Reusable clamps (50 uses)

Gyrus, ACMI PK

£8,006† - £205 (Curved Open)

Dedicated ESVS generator. Single use instruments

Gyrus, ACMI PK Super Pulse

£13,518† - £205 (Curved Open)

Dedicated ESVS generator Single use instruments

Valleylab, Ligasure™

£14,195 £602 (Xtend)

£133 Dedicated ESVS generator. Reusable holder ¥ with single use instruments

Valleylab, Triad™

£23,941 £602 (Xtend)

£133 General purpose energy platform. Reusable holder¥ with single use

instruments Martin, maXium

£12,534 £929 (80-971-28)

- General purpose generator. Reusable clamps (50 uses)

† Gyrus offer the generator as a loan item. ¥ Valleylab states the reusable clamps can be used indefinitely – Costings in Table 8 assume the clamps are reused 500 times.

Economic analysis 15

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Table 8 Other costs used in the economic comparison between VHESVS and VHsuture

Cost factor Value Comments Cost information source

Hospital bed per day (NHS)

£243 • Personal Social Services Research Unit [24]

Suture £1.50 (ex VAT) ESVS saves 6 sutures per case Cardiff and Vale NHS Trust Decontamination of ESVS instruments

£1.05 each Detachable cables are not treated as an additional item

NHS PASA [25]

Economic analysis

We have compared the initial equipment investment cost and the ongoing consumable costs for performing vaginal hysterectomy with ESVS and also highlighted potential cost savings from reducing the number of sutures by 6 per case and from reducing the patient length of stay by 1, 2 or 3 days (Table 9). Additional costs of increased waste production associated with disposable instruments have not been included in this economic analysis.

Table 9 Cost of using ESVS systems and potential savings from reduced sutures and bed days

ESVS cost # (inc. VAT) Cost savings per case #

Manufacturer & generator Generator

cost Forceps cost per

case*

Suture costs

(inc. VAT)

If patient stay

reduced by 1 day

If patient stay

reduced by 2 days

If patient stay

reduced by 3 days

BOWA, Arc350L £11,163 £88

ERBE VIO £14,635 £14

Gyrus, PK £9,307 £241

Gyrus, PK SuperPulse £15,884 £241

Gyrus (loan generator) - £241

Valleylab, Ligasure™ £16,679 £159

Valleylab, Ligasure™(loan) - £159

Valleylab, Triad™ £28,131 £ 159

Martin, maXium £14,727 £23

£10.58 £243 £486 £729

* for reusable instruments this includes decontamination costs & cost of replacement after the number of reuses stated in Table 6 # costs calculated assuming costs listed in Tables 6 and 7.

Economic analysis 16

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Based on figures in Table 9, ESVS systems using entirely reusable forceps/applicators (ERBE and Martin) have the lowest annual consumable cost and this is nearly offset by saving in the costs of sutures, assuming the reusable forceps need to be replaced after every 50 cases. Clearly, for these systems, theatres may need to purchase up to 4 sets of reusable ESVS forceps/applicators, to enable sufficient theatre packs to be in circulation, and budget to replace the forceps, in accordance with the manufacturers guidance (see Table 7). For all other systems the increased cost in consumables is only cost effective if accompanied by cost savings achieved thorough reducing the patient’s stay.

Published papers (Table 2) and expert opinion (Table 5) show that it is possible to reduce the patient stay by 1 day when using ESVS for vaginal hysterectomy, compared with using sutures alone. Furthermore, if the availability of ESVS encourages surgeons to switch to the vaginal approach then patient stay may be reduced by at least 2 or 3 days, compared with an abdominal hysterectomy, and be provided in a 24-hour day case surgery setting, as is currently undertaken for vaginal hysterectomy using sutures [12].

Under Payment by Results, vaginal and abdominal hysterectomy have the same Healthcare Resource Group code (M07) and NHS Trusts are currently paid £2633 for elective and £3327 for non-elective procedures [6]. The potential for ESVS to facilitate wider use of vaginal hysterectomy over abdominal hysterectomy and reductions in the patient’s hospital stay does provide a financial incentive for using ESVS in hysterectomy, in addition to the patient benefit.

If the perceived decrease in operating time, a scarce resource, is borne out in the wider NHS setting by increasing the number of cases managed on each theatre list, this may also be an economic driver in favour of the use of ESVS clamps.

Conclusions 17

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The use of ESVS by surgeons already skilled in performing vaginal hysterectomy has enabled them to undertake more complex cases and they have found that trainee surgeons find the technique is easy to learn. ESVS reduces the operating time for vaginal hysterectomy and fewer sutures are required. Some surgeons report that they have safely reduced patient stay, with several centres now providing hysterectomy as a 24 hour or outpatient service [18, 21].

These early studies indicate that ESVS was not associated with an increase in post-operative complication rates. Unintended contact while the ESVS applicator is still hot can cause local tissue damage but is preventable by implementing the appropriate surgical technique.

ESVS also brings significant patient benefits including reduced pain and the potential for reduced hospital stay.

Investment in ESVS technology can bring direct financial benefits if the additional cost is balanced by significant reductions in length of stay. Long term cost savings are possible but this is dependent on the manufacturer’s pricing policy, whether the ESVS generator is available as a loan item and if their forceps are reusable or single-use.

Further independent studies are needed to assess the clinical effectiveness of ESVS systems for vaginal hysterectomy, in particular the newer ESVS systems and applicators on the market, as this factor will also influence the purchasing decision.

We conclude that ESVS has the potential to facilitate vaginal hysterectomy in a larger proportion of cases than at present. The introduction of this technology could enable more surgeons to extend their indications for vaginal hysterectomy so they can perform more vaginal hysterectomies and fewer abdominal hysterectomies, as recommended by the NICE guidelines [1].

Acknowledgements 18

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We would like to thank the following for their help with this evidence review:

Saikat Banerjee, Consultant Obstetrician and Gynaecologist, Ashford & St Peter’s NHS Hospitals, Chertsey, Surrey

Liz Bruen, Endometriosis and Pelvic Pain Nurse Practitioner, University Hospital of Wales, Cardiff

Phil Chia, Consultant Obstetrician and Gynaecologist, Royal Bolton Hospital, Bolton

Patrick Chien, Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee

Jill Clash, Procurement Specialist, Theatres, University Hospital of Wales, Cardiff

Nigel Davies, Consultant Obstetrician and Gynaecologist, Llandough Hospital, Cardiff

Tony Griffiths, Consultant Obstetrician and Gynaecologist, University Hospital of Wales, Cardiff

Judith Hall, Consultant Anaesthetist & Acting Head of the Department of Anaesthetics, Cardiff University, Cardiff

Mohammed Hefni, Consultant Obstetrician and Gynaecologist, Benenden Hospital , Kent

Laurie Jones, Assessment Nurse, Ambulatory Care Services, University Hospital of Wales, Cardiff

Adam Magos, Consultant Obstetrician and Gynaecologist, Royal Free Hospital, London

Peter O’Donovan, Professor of Obstetrics and Gynaecology, Bradford Royal Infirmary, Bradford (Steering Group)

Richard Penketh, Clinical Director of Obstetrics and Gynaecology, Cardiff and Vale NHS Trust, Cardiff (Steering Group)

Edward Shaxted, Professor of Obstetrics and Gynaecology, Northampton General Hospital, Northampton (Steering Group)

Judith Smith, Theatre Manager, Ambulatory Care Services, University Hospital of Wales, Cardiff

Rajiv Varma, Consultant Obstetrician and Gynaecologist, Basildon and Thurrock University Hospital, Basildon (Steering Group)

Sally Whitfield, Gynaecology Clinical Leader, Theatres, Llandough Hospital, Cardiff

Peter Willson, Consultant Paediatric and Upper Genitourinary Surgeon, Kingston Hospital, Surrey

References 19

CEP 07019: 2007

1. NICE Guidelines for Heavy Menstrual Bleeding, 2007. www.nice.org.uk/guidance/index.jsp?action=byID&o=11002

2. Johnson N et al. Surgical approach to hysterectomy for benign gynaecological disease.

Cochrane Database of Systematic Reviews 2006, Issue 2.

3. Department of Health. Hospital Episode Statistics Online – main operations. www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=192

4. Health Solutions Wales. Annual Patient Episode Database for Wales (PEDW) Tables –

main operations. howis.wales.nhs.uk/sites3/page.cfm?orgid=527&pid=10906

5. ISD Scotland. Inpatient, day case and outpatient activity – surgical procedures and operations. www.isdscotland.org/isd/4334.html

6. Department of Health. National Tariff 2006-7. www.dh.gov.uk/en/Publicationsandstatistics

/Publications/PublicationsPolicyAndGuidance/DH_062914

7. Johnson N et al. Methods of hysterectomy: systematic review and meta-analysis of randominsed controlled trials BMJ 2005:330:1478 (bmj.com 2005;330:1478).

8. Dunn TS et al. Vaginal hysterectomies performed in a residency program: can we

increase the number? J Reprod Med 2006; 51(2): 83-86.

9. Varma R et al. Vaginal route as the norm when planning hysterectomy for benign conditions: change in practice. Obstet Gynecol 2001; 97(4): 613-616.

10. Olah KS and Kalil M. Changing the route of hysterectomy: the results of a policy of

attempting the vaginal approach in all cases of dysfunctional uterine bleeding. Eur J Obstet Gynecol Reprod Biol 2006; 125(2): 243-247.

11. Kovac SR et al. Guidelines for the selection of the route of hysterectomy: application in

a resident clinic population. Am J Obstet Gynecol 2002; 187(6): 1521-1527.

12. Penketh R et al. A prospective observational study of the safety and acceptability of vaginal hysterectomy performed in a 24-hour day case surgery setting. BJOG 2007;114: 430-436.

13. Maresh MJA et al. The VALUE national hysterectomy study: description of the patients

and their surgery. BJOG 2002; 109: 302-312.

14. MDA 02037 Low/medium power electrosurgery review 2002. Medical Devices Agency report is now accessible on www.pasa.nhs.uk/cep

15. CEP 06008 Electrosurgical vessel sealing systems 2006. Centre for Evidence-based

Purchasing. www.pasa.nhs.uk/cep

16. Cronjé HS and de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet 2005; 91(3): 243-245.

References 20

CEP 07019: 2007

17. Hefni MA et al. Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomised controlled trial. BJOG 2005; 112(3): 329-333.

18. Levy B. and Emery L. Randomized trial of suture versus electrosurgical bipolar vessel

sealing in vaginal hysterectomy. Obstet Gynecol 2003; 102(1): 147-151.

19. Zubke W et al. Vaginal hysterectomy: a new approach using bicoagulation forceps. Gynecol Surg 2004; 1: 179-182.

20. Ding Z et al. Use of LigaSure bipolar diathermy system in vaginal hysterectomy. J

Obstet Gynaecol 2005; 25(1): 49-51.

21. Clavé H et al. Painless vaginal hysterectomy with thermal hemostasis (results of a series of 152 cases). Gynecol Surg 2005; 2: 101-105.

22. Garry R et al. EVALUATE hysterectomy trial: a multicentre randomised trial comparing

abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess 2004; 8(26).

23. Mäkinen J et al. Morbidity of 10,110 hysterectomies by type of approach. Hum Reprod

2001; 16(7): 1473-1478.

24. Curtis L and Netten A. Unit Costs of Health and Social Care 2006. Canterbury: Personal Social Servicees Research Unit, University of Kent, 2006.

25. PASA. Main principles to be considered when setting up a decontamination service for

PCTs, Appendix B. 2005 (NB This information is only available on the NHSnet PASA website. Non-NHS personnel wishing to access this data should contact PASA.) nww.pasa.nhs.uk/PASAWeb/Guidance/Decontamination/Guidancedocuments.htm

Appendix 1: Literature search strategy 21

CEP 07019: 2007

Papers describing the use of ESVS in VH were identified in Medline by searching for studies on vaginal hysterectomy for benign conditions (excluding prolapse) which concentrated on electrosurgical methods of haemostasis. As the ESVS products are relatively recent devices, this search was limited to the last twenty years. The search strategy was as follows:

1 Hysterectomy, Vaginal/ 2 limit 1 to (humans and english language and yr="1998 - 2007") 3 cancer.mp. 4 2 not 3 5 Uterine Prolapse/ or Prolapse/ 6 4 not 5 7 Electrosurgery/ 8 Electrocoagulation/ 9 Hemostasis/ 10 Ligation/ 11 7 or 8 or 9 or 10 12 6 and 11

This strategy produced 15 results. The titles and abstracts were reviewed and four papers were found that compared ESVS with traditional suturing techniques [16, 17, 18, 20]. The same search strategy was run in Embase resulting in 28 papers. Review of titles and abstracts yielded one additional study [21]. Review of the references cited in these five papers revealed Zubke et al [19], which was not listed in either of these databases but was cited in Clave et al [21]. All six papers are summarised in Table 32

Papers used to provide background information for this evidence review were obtained using a broader search strategy:

1 Vaginal Hysterectomy/ 2 limit 1 to (humans and english language and yr="1998 - 2007") 3 cancer.mp. 4 2 not 3 5 Uterine Prolapse/ or Prolapse/ 6 4 not 5 7 limit 6 to journal article 8 limit 7 to case reports 9 7 not 8 10 vaginal.ab,ti. 11 9 and 10

This search strategy resulted in 231 papers. A manual review of their titles and abstracts was used to select the remaining papers cited in this report, with the exception of Maresh et al [13] which was referenced in Garry et al [22].

Appendix 2: Recording expert opinion 22

CEP 07019: 2007

Data summary sheet used to record expert opinions during telephone interviews

Resource Summary (Page 1) Abdominal

Hysterectomy (sutures)

Vaginal Hysterectomy

(sutures)

Vaginal Hysterectomy

(ESVS) COMMENTS

Length of session/list (hrs)

No. of patients per session/list

Operating time (minutes)

Pre & post-operative time (in theatre, mins)

Ope

ratio

n Ti

me

Total time in theatre (per patient, mins)

Surgeon (Consultant)

Surgeon (SpR)

Assistant (SpR)

Scrub nurse

Others (surgical)

Anaesthetist

Anaesthetic nurse

ODT / ODP Ope

ratin

g Th

eatr

e St

aff (

No.

& g

rade

)

Other (anaesthetics)

Length of stay

War

d

Type of ward

Total No. of hysterectomy patients per year

% not suitable for VH

Expected lifetime of ESVS equipment

ESVS

Additional medical training

Appendix 2: Recording expert opinion 23

CEP 07019: 2007

Data summary sheet used to record expert opinions during telephone interviews (continued)

Resource Summary (Page 2) Abdominal

Hysterectomy (sutures)

Vaginal Hysterectomy

(sutures)

Vaginal Hysterectomy

(ESVS) COMMENTS

OT consumables

· sutures (type and number)

· disposable instruments

· blood units

Con

sum

able

s

· other

· anaesthesia

· antibiotics

· pain relief

· anti-coagulation Med

icat

ion

· other

Complication rates

Additional ward days

Return to theatre

Additional medication

Other consequence

Pre-op preparation

· lab tests

Com

plic

atio

ns

· O/P visits

· other

Post-op follow-up

· lab tests

· O/P visits

· phone calls (staff grade)

· other

Patient return to work (days/weeks)

Hos

pita

l out

patie

nt

Local policy re reusable vs. disposable instruments

Oth

er

issu

es

Appendix 3: Expert opinion 24

CEP 07019: 2007

Summary of expert opinions

Opinions of five consultant surgeons in UK (*three have ESVS experience in VH)

Expert

Abdominal Hysterectomy

(inpatient stay in days)

Abdominal Hysterectomy

(operating time in minutes)

Patients per operating session

(210 minutes)

No. of hysterectomies

performed by the consultant

surgeon each

A* 3-5 30 3 30 B* 4 40 5 (7 hour session) 32 C* 4 40 5 150

D 3 20 2 (major procedures) 48

E 3-5 45 2-3 50 Value used in

economic analysis 4 40 50

Appendix 4: Glossary 25

CEP 07019: 2007

AH, abdominal hysterectomy – surgical removal of the uterus via an incision in the abdomen (also known as laparotomy).

Bipolar forceps/clamp – an electrosurgical applicator with two tines for grasping the tissue to be coagulated and concentrating the current flow in the tissue volume between the tines. Standard bipolar forceps are suitable for sealing small vessels and narrow tissue bundles (usually 2 mm in diameter) whilst ESVS bipolar forceps can compress larger tissue bundles and vessels (up to 7mm diameter).

Electrosurgery is also known as surgical diathermy. Heating in body tissues is caused by their impedance to the flow of high frequency electric current produced by the generator (electrosurgical unit, ESU). The high current density at the tip of the active electrode creates high temperatures in the tissue and produces cutting or coagulation (haemostasis) depending on the electrode type, output waveform, power level and surgical technique (12).

ESVS, electrosurgical vessel sealing – Electrosurgical vessel sealing systems comprise ESU generators capable of high current at low voltages and monitoring changes in tissue impedance combined with ESVS bipolar forceps to produce a flexible, transparent and plastic-like seal when fusion is complete(14). Microprocessor-control is used to achieve a reproducible electrosurgical effect and will automatically ‘power off’ and/or alarm when the system assesses an optimum seal has been achieved. Many systems are suitable for sealing tissue bundles up to 7mm in diameter.

Haemostasis – means by which bleeding is stopped, either by physiological healing process or by a man-made method (clips, sutures, staples or tissue heating).

LAVH, laparoscopically-assisted vaginal hysterectomy – surgical removal of the uterus whereby the superior ligaments are divided laparoscopically and the uterus is removed via an incision around the cervix. The proportion of the operation carried out laparoscopically varies.

LH, laparoscopic hysterectomy – surgical removal of the uterus solely using laparoscopic instruments (‘keyhole surgery’).

Oophorectomy – surgical removal of one or both ovaries.

Prolapse – condition in which the support of the uterus and/or vagina is damaged leading to displacement of these organs. The cervix and uterus may extend beyond the vaginal orifice.

RCT - randomised controlled trial – A research study in which the investigators randomly allocate eligible people into (eg treatment and control) groups to receive or not to receive one or more interventions that are being compared. The results are assessed by comparing outcomes in the treatment and control groups.

VH, vaginal hysterectomy – surgical removal of the uterus via an incision around the cervix.

Appendix 5: Product details 26

CEP 07019: 2007

ESVS product details

(prices exclude VAT, see reference 14 for more information)

Generator Notes Cost Applicator notes Cost

BOWA Arc 350

General purpose generator. High current bipolar coagulation mode required. Cannot be retro-fitted

£9,500

TissueSeal reusable, lockable handpieces (reusable up to 200 times) with disposable electrodes 280 mm handpiece with 30º angled electrode recommended for VH

Handpieces - £825 Electrodes - £350 for 5

ERBE VIO 300D + BiClamp upgrade

General purpose generator. BiClamp available as upgrade

£8,995 + £3,460

BiClamps reusable 50 times. All are curved. 200C (length 200 mm) and 270C (270 mm) are recommended for VH and have ceramic coating. Also, 210 (210 mm) with gripping surface

200C - £512 270C - £559 210 - £528

Gyrus ACMI PK PK Super Pulse

Dedicated bipolar generator Super Pulse allows two applicators to be connected Generators supplied on loan, so no service costs

£8,006 £13,518

Single use PK Open Seal Forceps for VH are straight (length 295 mm) or angled (295 mm)

Curved forceps - £205 Angled forceps - £303

Martin maXium

General purpose generator

£12534

Reusable marClamp forceps are available as curved instruments in 4 sizes and straight instruments in 3 sizes The marClamp 180® ,curved version, (length 280mm) can be used for VH

Curved forceps - £644/£760/ £780/£853

Straight forceps - £747/£771/ £841

Valleylab LigaSure™ Force Triad™

LigaSure™ is a dedicated ESVS generator Force Triad™ is a general purpose energy platform providing a tissue fusion output

£14,195 £23,941

Single use Atlas (length 200 mm) and Impact (180 mm) look like laparoscopic instruments - rotating shaft, gun-style grip and integral dissecting blade. The Impact has larger, curved jaws and rotates less

The reusable applicators have reusable handpieces (no reuse limit prescribed) and single use electrodes with 30º angle - Max (230 mm) and Xtend (280 mm)

Single use: Atlas - £271 Impact - £377 Reusable: Handpieces: Max – £538 Xtend - £602 Electrodes : £1,373 - £1,591 (12 per pack)

Appendix 6: Supplier details 27

CEP 07019: 2007

Manufacturer BOWA ERBE Gyrus ACMI

Supplier Avail Medical ERBE Medical UK Ltd Gyrus International Ltd

Address 8 Ninian Park Tame Valley Dosthill Tamworth Staffordshire B77 5ES

The Antler Complex 2 Bruntcliffe Way Morley Leeds LS27 0JG

410 Wharfedale Road Winnersh Triangle Wokingham Berkshire RG41 5RA

Telephone 0182 728 8883 0113 253 0333 0118 921 9700

Fax 0182 728 8334 0113 253 2733 0118 921 9800

Webpage www.availmedical.com www.erbeuk.com www.gyrusmedical.com

Manufacturer Martin Valleylab

Supplier Cross Technologies plc. (QUADOS) after 1/1/08 #

Covidien (formerly known as Tyco Healthcare UK)

Address 5 Lakeside Business Park Swan Lane Sandhurst Berkshire GU47 9DN

154 Fareham Road Gosport Hampshire PO13 0AS

Telephone 01252 878 999 01329 224226

Fax 01252 877 288 01329 224390

Webpage klsmartin.com www.crosstechplc.com www.quados.co.uk

www.ligasure.com

# Supplier contact details before 1st January 2008:

sandra.braunbart@klsmartin.com Tel. 0049 7461 706 321 Fax. 0049 7461 706 205

Author and report information 28

CEP 07019: 2007

Evidence review: Electrosurgical vessel sealing in vaginal hysterectomy Dr Susan C Peirce, Dr Diane C Crawford Clinical Engineering Device Assessment and Reporting (CEDAR) Cardiff Medicentre Cardiff CF14 4UJ Tel: 029 2068 2120 Fax: 029 2075 0239 Email: diane.crawford@cardiffandvale.wales.nhs.uk For more information on CEDAR and our earlier reports visit www.cedar.wales.nhs.uk About CEP The Centre for Evidence-based Purchasing (CEP) is part of the Policy and Innovation Directorate of the NHS Purchasing and Supply Agency. We underpin purchasing decisions by providing objective evidence to support the use of innovative technologies, assess value and develop nationally agreed protocols. © Crown Copyright 2007

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