Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Prostate Cancer and Prostatic Diseases (2007) 10, 316–322 & 2007 Nature Publishing Group All rights reserved 1365-7852/07 $30.00 www.nature.com/pcan REVIEW Photoselective vaporization of the prostate (GreenLight PV): lessons learnt after 3500 procedures F Gómez Sancha1, A Bachmann2, BB Choi3, S Tabatabaei4 and GH Muir5 1 Institute of Advanced Urological Surgery, Madrid, Spain; 2Department of Urology, University Hospital, Basel, Switzerland; Department of Urology, Weill Medical College of Cornell University, New York, NY, USA; 4Department of Urology, Massachusetts General Hospital, Boston, MA, USA and 5Department of Urology, King’s College Hospital, London, UK 3 The technical recommendations of an international group of experts on photoselective vaporization of the prostate (PVP; GreenLight PV) for benign prostatic hyperplasia are described. Their experience stems from the treatment of over 3500 patients at five centres in Europe and the United States. The objectives of this physician-based initiative are to optimize the results achieved with PVP by standardizing the procedure, as well as to recommend training requirements. Prostate Cancer and Prostatic Diseases (2007) 10, 316–322; doi:10.1038/sj.pcan.4500989; published online 10 July 2007 Keywords: photoselective vaporization; BPH; laser therapy; KTP; PVP; GreenLight PV Introduction Benign prostatic hyperplasia (BPH) is a very common condition in the ageing male. A number of minimally invasive procedures have been developed with the objective of matching or increasing the efficacy of transurethral resection of the prostate (TURP) and lessening the associated morbidity. These include transurethral needle ablation (TUNA), which uses low-level radiofrequency energy to ablate prostate tissue, thermal ablation of prostate tissue using microwave energy and laser therapy. Holmium laser ablation of the prostate was first described in 1995 using the holmium:yttrium– aluminium–garnet (Ho:YAG) laser, which operates at a wavelength of 2100 nm.1 It is considered that tissue vaporization with the Ho:YAG laser is limited due to its high absorption by water. As a result, the laser fibre must be kept in direct contact with the tissue to achieve a relatively slow vaporization, which allows the treatment of very small (20–30 g) prostate glands. The technique was modified so that the pulsatile formation of vapour bubbles at the tip of the end firing optical fibres could be used to cut tissue, mimicking the surgical effects of TURP. Subsequently, with the introduction of a mechanical tissue morcellator/aspirator, Ho:YAG laser enucleation of the prostate (HoLEP) evolved. Recent results suggest that clinical outcome with HoLEP was comparable to TURP,2 but it has not been widely adopted as it is technically challenging and has a steep learning Correspondence: GH Muir, Department of Urology, King’s College London, King’s College Hospital, Denmark Hill, London SE5 9RS, UK. E-mail: [email protected] Received 25 April 2007; accepted 7 May 2007; published online 10 July 2007 curve. It has been recommended that a minimum of 50 procedures on smaller (o50 ml) prostate should be performed before larger prostate enucleations are attempted.3 Photoselective vaporization of the prostate (PVP) using the 80-W potassium–titanyl-phosphate (KTP) laser was first reported in 2003 in a pilot study involving men with prostates sized 24–76 ml with good outcome and minimal morbidity.4 The unique 532 nm wavelength that the laser operates at is highly absorbed by oxyhaemoglobin and minimally absorbed by water. This high absorption in haemoglobin limits the optical penetration depth of the KTP laser to 0.8 mm.5 Vaporization occurs from within the tissue where vapour bubbles form and burst the collagen matrix. The heat remaining in the tissue induces a coagulation zone of only 1–2 mm thickness. Although sufficient to achieve haemostasis, this may limit the large coagulation zone thought to be linked to postoperative oedema formation and irritative symptoms seen in Nd:YAG lasers.6 The primary difference between PVP and HoLEP is that PVP involves prostate tissue ablation through vaporization as opposed to enucleation. There has been a rapid and widespread acceptance of PVP worldwide, primarily due to its efficacy, safety and patient acceptance. Training recommendations are yet to be established, however, and training is considered an area for improvement. In this context, this paper describes the recommendations of an international group of experts on the PVP for BPH using GreenLight PV from its initial introduction into the clinical practice in 2002. Their experience stems from the treatment of over 3500 patients at five centres in Europe and the United States.7–10 The objectives of this physician-based initiative are to optimize the results achieved with PVP by standardizing the technique and to recommend training requirements. Photoselective vaporization of the prostate F Gómez Sancha et al The procedure Equipment The equipment involved in the PVP procedure is listed in Table 1. The technique described in this paper involves the GreenLight PV 80-W KTP laser system (laserscope). Although a modification of this system generating 120 W of power is becoming available, clinical experience with this equipment will be presented in future publications. Patient evaluation A standard preoperative workup according to the European Association of Urology and the American Association of Urology guidelines for any surgical procedure is conducted on the patient before the PVP procedure. Mandatory assessment includes evaluation of prostate size, as this has implications for the operating time. Transrectal ultrasound and computed tomography scan are the most reliable means to assess size and are preferable to digital rectal examination. Routine preoperative evaluation according to local guidelines is performed. Preoperative patient preparation Although there are studies showing that this procedure can be safely performed under anticoagulation, provided it is safe for the patient’s overall medical condition, antiplatelet (aspirin) and anticoagulation (warfarin) medications should be discontinued preoperatively, if possible. However, in experienced centres, such high-risk patients can be considered for operation; heparin or an equivalent high-molecular-weight anticoagulant should replace warfarin.11,12 Appropriate prophylactic antibiotics should be given perioperatively. Temperature monitoring of the patient is recommended and warm air blankets are applied, if necessary. Full-length elastic stockings or a sequential compression device should be used in addition to any local policies for deep vein thrombosis prophylaxis. 317 Anaesthesia Two forms of anaesthesia may be applied: general or spinal. The use of a paralytic agent for muscle relaxation is not necessary during the procedure. Local anaesthesia is generally not recommended. However, periprostatic block with sedation can be used in certain special circumstances, for example significant cardiac risk patients with relatively small gland. Operative technique The surgeon may stand or sit (preferably on a chair with back and arm rests). The patient is positioned in a modified lithotomy position with the legs in stirrups. Special attention should be given to avoid dramatic flexion and abduction of the hips and knees, which could affect blood supply to the lower extremities or cause neuropraxia. A video system is mandatory: the camera equipment is set up with a special 532 nm lens filter inserted between the camera and the telescope. This filter protects the camera and must be kept dry before and during the procedure to avoid image distortion. Both the camera and the filter should be protected from water Table 1 The equipment involved in the photoselective vaporization of the prostate technique GreenLight laser system 80 W output Laser fibre: 600 mm core diameter and is equipped with a 1800 mm quartz cap; side-firing; The beam has a forward deflection of 701 and a divergence angle of 151. It has a red marker to indicate the side of firing and blue marker to indicate opposite side to firing. A knob allows the surgeon to manipulate the fibre and also has a mark to indicate the side of firing Continuous flow laser cystoscope which accepts the GreenLight fibre 301 telescope (it is also possible to use a 121 scope) with a 7 French inner laser bridge and an external sheath with a beak visual obturator Self-sealing nipple to avoid water leakage around laser fibre Video system with camera cover to prevent water penetration Filtering laser mechanism for camera protection Continuous flow pump, gravity or suction (optional) Room temperature saline irrigation system Urethral dilators or otis urethrotome plus lubricant (standby) Catheter (standby) latex or silicone 16–20 French (large bore catheters not usually necessary for this procedure) 2 or 3 way (irrigation is usually not necessary) Laser goggles Suprapubic trocar (optional); resectoscope and diathermy machine (standby) Chair with arm rest (optional) All items are essential unless indicated. Prostate Cancer and Prostatic Diseases Photoselective vaporization of the prostate F Gómez Sancha et al 318 during the procedure using a laparoscopy sheath. The white balance is then checked. Laser goggles specifically filtering the 532 nm wavelength should be worn by all members of the team and any colour distortion that results noted, for example, the blue triangle on the laser tip indicating direction may appear in a different colour. The local laser safety protocol should be adhered to. It is important to remind the entire operating team about colour distortion, as some medications and instruments are colour coded and mistakes could occur if attention is not paid to colour changes due to the camera filter. The external sheath of the laser cystoscope has a beak at the tip that is not visualized with a 301 lens (it is seen with a 121 scope). The scope should be equipped with an optical obturator, which should be gently introduced through the urethra so as to limit any local damage and bleeding caused by this beak, particularly with a large median lobe prostate. Indeed, scope movements should always be gentle throughout the procedure for this reason. Irrigation is started and visualization made of the anatomy of the urethral sphincter and prostate; the position of the ureters and the bladder neck are also noted. The optical obturator is removed and replaced by the laser carrier and the laser fibre is introduced, which should be set up with no torque in the lead to reduce any resistance that might damage the laser fibre. Finger tip adjustments of the laser fibre position within the prostate are recommended rather than using rotation of the arm or wrist, as this assists manipulation and prevents fatigue. The fibre should be placed at an adequate distance from the telescope lens to prevent damage to the latter or to the cystoscope’s beak. Constant visibility of the laser fibre tip should be maintained; it is best to keep the blue triangle on the fibre in view at all times. The power is set at 80 W for laser vaporization. The most important treatment parameter for efficiency and speed is the working distance, for example, the separation of the fibre and the tissue. Although it is important to keep a close contact between the laser and the tissue, it is important that a short distance be maintained. The laser is fired perpendicularly in lateral side-to-side slow sweeping movements (Figure 1), which are distinct from the back and forward actions of a TURP loop. If the laser fires at too great a distance from the tissue, then coagulation and not vaporization will result. Direct contact with the prostate tissue should also be limited to prevent degradation of the fibre, although this is sometimes inevitable, particularly in patients with large median lobes. Effective vaporization is indicated by bubble formation when the laser is fired. Vigorous bubble formation from effective vaporization can, at times, create subtle vibration of the laser fibre, which can be felt by the surgeon’s hand. It is recommended that long continuous periods of vaporization are aimed for rather than intermittent (on/off) usage, as this will optimize energy usage and so improve efficacy. With increased experience, longer periods of laser firing will become possible achieving optimal debulking (Figure 2). During vaporization, tissue may adhere to the tip of the fibre requiring it to be cleaned. Two options can be considered for this process: turn the laser off and clean with a gauze outside the body; or with experienced operators, remove the tissue in situ by rubbing the turned-off laser in an upward motion towards the tip of the fibre against previously lasered tissue. Prostate Cancer and Prostatic Diseases Figure 1 Photoselective vaporization of the prostate. The fibre should be rotated in a sweeping fashion with rotation amplitude reduced to an arc of 601 (c) to avoid an overt increase in distance from the fibre to the tissue, which would reduce vaporization efficiency and increase coagulation (a, b). Tissue vaporization strategies The ultimate goal of tissue vaporization is to create a non-obstructive prostatic urethra that is smooth and easily catheterizable. To achieve this goal, the operator should develop a methodical approach to the laser vaporization that is safe, efficient and reproducible. In terms of overall tissue ablation, the operator should aim to generate smooth tissue surfaces and to remove tissue in a uniform and systematic manner. As with TURP, there are several approaches that can be taken and no single method is recommended. The Malek technique. In the Malek procedure, the lateral lobes of the prostate are vaporized starting at the bladder neck.13 The laser beam is moved slowly along the length and breadth of each lobe, taking care at the apex to avoid the external sphincter. The lobes are ablated evenly to the level of the capsular fibres. The median lobe is then vaporized to the level of the transverse fibres of the vesical neck. In the case of large median lobes, this is partially ablated before the lateral lobes to facilitate the movement of the scope and irrigation. The vaporization incision technique. A modified technique that can be applied for large volume prostates has been developed.14 The technique consists of a midline incision in the median lobe that is carried down to trigone. A second incision is made lateral to the median lobe and the tissue in between is vaporized. A contralateral procedure is performed. A high lateral lobe incision is then made and carried down to the floor of the prostate on both sides. The apex is vaporized last. The spiral technique. The objective of the spiral technique is to develop a clear cavity in a stepwise fashion, as if spiralling down through the prostate (Figure 3a). The basic principle is to vaporize a single area completely at any one time. Vaporization starts at the middle lobe and then the bladder neck followed by the proximal lateral lobes, which are sometimes dealt with in several stages (Figures 3b–e). The final stages are the floor of the prostate and the apex. It can be difficult to determine the prostate capsule, as the lasered tissue can develop a Photoselective vaporization of the prostate F Gómez Sancha et al Novice: 250,000 joules Expert: 180,000 joules 319 0 2h 15min Laser on 0 1h 10min Laser off Figure 2 Representative pattern of energy usage by experienced operators of the photoselective vaporization of the prostate technique compared with inexperienced operators. With experience, surgeons keep the pauses to a minimum during the procedure, increasing efficiency and reducing overall surgical time. Outcome in a typical 60 g prostate is shown. Figure 3 The spiral technique showing: (a) the principle of spiralling down through the prostate; (b–e) vaporization starting at the middle lobe, then the bladder neck followed by the proximal lateral lobes. fairly homogenous appearance. Certainly, at the end of the procedure, the verumontanum should be clear of obstruction and there should be a clear passage from the apex to the bladder base. Occasionally, a large middle lobe may be encountered, which can be a problem at the end of vaporization as a tiny flap of middle lobe may Prostate Cancer and Prostatic Diseases Photoselective vaporization of the prostate F Gómez Sancha et al 320 obscure the ureters. In such rare instances, a miniresection of the residual middle lobe should be considered. the appearance of the prostate tissue following the procedure is more ragged than that resulting from a TURP. The anterior start technique. This procedure has been developed in Madrid and New York centres.15 The first step in the procedure is to vaporize a tunnel from an 11 o’clock to 1 o’clock position from the bladder neck through to the verumontanum (Figures 4 and 5a). The lateral lobes are then vaporized, paying regard to the median lobe of the prostate (Figure 5b). The vaporization is carried down to the apex, removing the apical tissue while respecting the verumontanum (Figure 5c). The median lobe is flattened (Figure 5d) and a midline incision of the median lobe (or bladder neck) made, which will avoid damage to the ureteral orifices (Figure 5e). The remainder of the median lobe is then removed by firing the laser from a medial to a lateral position. Additional incisions will reveal the depth necessary to reach the capsular fibres (Figure 5f). In the final result, the solitary verumontanum is noted (Figure 5g). Bleeding There is usually no clinically significant bleeding during GreenLight laser prostatectomy. If bleeding does occur, it is important not to panic as it is usually of minimal clinical significance: some bleeding will occur during almost any urinary endoscopy. The irrigation efficiency of the 21–23 F laser cystoscope is much less than larger The Basel technique. This technique starts with tunnelling at 5 o’clock and 7 o’clock down from the bladder neck to the verumontanum. The lateral lobes are then vaporized, starting from the tunnel upwards (for example from 5 o’clock to 11 o’clock) to the level of the surgical capsule. Subsequently, both the apex and the anterior part of the prostate are vaporized. The median lobe is always treated last as the fibre is more likely to come into direct contact with the tissue and this increases the risk of fibre degradation. Consequently, treating the median lobe last avoids early fibre degradation, which is of utmost importance with large prostates. Finalizing the procedure. In deciding if sufficient tissue has been removed, the bladder should be emptied and the cavity that has been generated, viewed when it is not under pressure. There should be a clear view towards the bladder neck from the verumontanum with presentation of a TURP-like cavity (Figure 6). Irregularities are checked for as well as the integrity of the ureters. Any bleeding is noted and dealt with. It should be noted that Figure 4 The first stage in the anterior start technique: vaporization of a tunnel from an 11 o’clock to 1 o’clock position from the bladder neck through to the verumontanum. Prostate Cancer and Prostatic Diseases Figure 5 The anterior start technique: (a) vaporization of a tunnel from an 11 o’clock to 1 o’clock position from the bladder neck through to the verumontanum; (b) vaporization of the lateral lobes; (c) vaporization down to the apex; (d) flattening of the median lobe; (e) midline incision made in the median lobe; (f) additional incisions made at the bladder neck to identify the capsular fibres; (g) solitary verumontanum revealed. Photoselective vaporization of the prostate F Gómez Sancha et al 321 Prostate volume (ml) 200 150 100 50 R-Quadrat linear = 0.24 0 0 100000 200000 300000 400000 500000 600000 700000 Energy (J) Figure 6 The final cystoscope image following laser vaporization of the prostate. Figure 7 Scattergram depicting energy usage with the GreenLight PV laser based on prostate size in patients treated at the University of Basel. resectoscopes, and even tiny bleeders can thus obscure the vision. These are usually easily dealt with by simply continuing the procedure; they should not stop rapid tissue removal as long as visibility is maintained. Specific strategies for dealing with troublesome bleeding points are usually only needed for very large or very inflamed prostates, in which case a stepwise strategy is adopted. Irrigation bag height may be increased, or if an inflow–outflow pump is used, the flow rate or pressure rate may be increased to improve visibility. If the bleeder is difficult to coagulate, it is useful to reduce the laser output power to 30 W and to defocus the beam, thereby increasing the working distance and generating coagulation of the tissue. If it is difficult to access the source of bleeding, then tissue can be ablated around the site first, but it is not recommended that any blood vessel be lasered directly as vapour bubble formation occurs inside and this can open up the vessel further. To get orientation and visibility, the cystoscope is drawn back behind the verumontanum with increased irrigation, but the laser fibre remains in the prostatic fossa to treat the bleeding source. A small bleed at the bladder neck often can be controlled with a Foley catheter with a large balloon on traction. A more significant arterial bleed should be managed by inserting a suprapubic trocar with double inflow through the scope and suprapubic outflow or a 5 mm laparoscopic trocar, allowing a clear view to be obtained. Very rarely, electrocautery or a resectoscope may be needed for arterial bleeders. Power usage There are no limits to the amount of energy that is used during a single procedure, but obviously larger prostates require more energy. Although no hard-and-fast rule can be given, general guidelines are that for a prostate sized 40 ml, the energy usage is of the order of 150 000 J; for a 50 ml prostate, the energy usage is 200 000 J and for 100 ml prostate, the energy requirement is over 350 000 J (Figure 7). Also, beginners in the technique tend to use power less efficiently and this needs to be taken into account. More than one laser fibre may be required during a single procedure when treating bigger glands. It should be noted that fibres are for single patient use and should not be reused. Catheterization For elective patients operated under general anaesthetic, the need for a postoperative catheter is at the discretion of the surgeon. If necessary, the duration is generally short, from a few hours up to overnight. Longer catheterization times may be preferred in patients with urinary retention, with very large prostates, the elderly and those on anticoagulants or those who fail the initial voiding trial due to some swelling/inflammation around the bladder neck or prostatic urethra.9 Training recommendations For both trainees and trained urologists, we recommend the following approach to case selection when learning PVP. The first 10 patients should have prostates less than 50 g; these patients should not be in retention, have prostatitis, a large median lobe or have undergone a previous prostate procedure, for example TUNA or microwave therapy. A formal audit on outcome is recommended after the completion of the 10 cases. If there have been any major complications or cases where the patient is unable to void spontaneously, then a further 10 cases are recommended and another audit conducted on these cases. To achieve a sufficient competence level, it appears that around 30–50 procedures should be conducted for most users. A surgeon should be able to deliver 200 000 J/h before starting very large glands. Although ‘wet labs’ and simulators are not widely available, it seems sensible to look at developing such facilities for those learning PVP in the future. Urological trainees It is recommended that training is conducted by trainers from an accredited training centre. Local guidelines must also apply. Training should be conducted under direct Prostate Cancer and Prostatic Diseases Photoselective vaporization of the prostate F Gómez Sancha et al 322 supervision and the trainee should be already experienced in endoscopic techniques; previous experience of video endoscopy is helpful. It is necessary to undertake a laser safety course in most countries. Interestingly, experience in the TURP procedure does not seem to provide much benefit when learning PVP, and adaptation of the TURP technique is not advised. However, surgeons who are experienced with TURP tend to learn PVP more easily as they are familiar with the anatomical landmarks. Experienced urologists For experienced urologists, it is strongly recommended that they attend a formal training course and to have an experienced mentor present at their first cases. Viewing a PVP training video alone is not sufficient. The new 120 W laser now coming into use will require a similar level of technical knowledge to the 80-W laser system. The handling of the 120-W laser is comparable with the 80 W laser, but with the higher energy application, tissue removal is likely to be increased. Acknowledgements This study was supported by an unrestricted educational grant from Laserscope, CA, USA; Urology Research Fund, King’s College, London, UK and Instituto de Cirugı́a Urológica Avanzada, Madrid, Spain. References 1 Gilling PJ, Cass CB, Malcolm AR, Fraundorfer MR. Combination holmium and Nd:YAG laser ablation of the prostate: initial clinical experience. J Endourol 1995; 9: 151–153. 2 Wilson LC, Gilling PJ, Williams A, Kennett KM, Frampton CM, Westenberg AM et al. A randomised trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years. Eur Urol 2006; 50: 569–573. Prostate Cancer and Prostatic Diseases 3 Shah HN, Mahajan AP, Sodha HS, Hegde S, Mohile PD, Bansal MB. Prospective evaluation of the learning curve for holmium laser enucleation of the prostate. J Urol 2007; 177: 1468–1474. 4 Hai MA, Malek RS. Photoselective vaporization of the prostate: initial experience with a new 80 W KTP laser for the treatment of benign prostatic hyperplasia. J Endourol 2003; 17: 93–96. 5 Jacques SL. Laser–tissue interactions. Photochemical, photothermal, and photomechanical. Surg Clin North Am 1992; 72: 531–558. 6 Kuntzman RS, Malek RS, Barrett DM, Bostwick DG. High-power (60-watt) potassium–titanyl-phosphate laser vaporization prostatectomy in living canines and in human and canine cadavers. Urology 1997; 49: 703–708. 7 Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A et al. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol 2005; 48: 965–971. 8 Ruszat R, Wyler S, Seifert HH, Reich O, Forster T, Stief CG et al. Photoselective vaporization of the prostate: experience with prostate adenomas 480 cm3. Urologe A 2006; 45: 858–864. 9 Ruszat R, Wyler S, Seifert HH, Reich O, Forster T, Sulser T et al. Photoselective vaporization of the prostate: subgroup analysis of men with refractory urinary retention. Eur Urol 2006; 50: 1040–1049. 10 Rajbabu K, Dudderidge T, Barber N, Walsh K, Muir G. Evaluation of ideal irrigation fluid in ‘Greenlight’ photoselective vapourization of the prostate. Prostate Cancer Prostatic Dis 2007; 10: 101–103. 11 Reich O, Bachmann A, Schneede P, Zaak D, Sulser T, Hofstetter A. Experimental comparison of high power (80 W) potassium titanyl phosphate laser vaporization and transurethral resection of the prostate. J Urol 2004; 171 (6 Part 1): 2502–2504. 12 Ruszat R, Wyler S, Forster T, Reich O, Stief CG, Gasser TC et al. Safety and effectiveness of photoselective vaporization of the prostate (pvp) in patients on ongoing oral anticoagulation. Eur Urol 2007; 51: 1031–1041. 13 Malek RS, Kuntzman RS, Barrett DM. High power potassium– titanyl-phosphate laser vaporization prostatectomy. J Urol 2000; 163: 1730–1733. 14 Sandhu J, Te AE. Photoselective vaporization of the prostate – the vaporization incision technique for large volume prostates. J Urol 2005; 173 (4 Suppl): 366, abstract no. 1346. 15 Gomez-Sancha F, Castillon-Vela I. KTP laser photoselective vaporization of the prostate: single surgeon experience on 150 patients. J Urol 2006; 175: 491, abstract 1523.