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Nel trattamento dell’IPB

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Presentazione sul tema: "Nel trattamento dell’IPB"— Transcript della presentazione:

1 Nel trattamento dell’IPB
The GreenLight PVP Workshop PowerPoint Presentation gives an overview of how a KTP laser works, how different lasers generate different tissue effects, and why a high power KTP laser is the ideal tool to treat BPH. The Photoselective Vaporization of the Prostate (PVP) procedure is explained. The presentation closes with clinical data of a multi-center study and a single center long-term durability study. The presentation is designed as 60 minute workshop didactic. It should be supplemented by a lecture on laser safety included in the file “GreenLight PVP Workshop Presentation – Laser Safety Supplement” We encourage urologists to include their own experience in the presentation. Sample slides can be found at the beginning and end of the presentation. These slides can easily be customized by replacing the placeholders “<>” with specific information. The slides entitled “Personal Experience” are hidden by default. To show them in the presentation, select the slides and select the “Hide Slide” button in the Slide Show pull-down menu. To give presenters some guidance in how to narrate the slides, a manuscript was prepared that can be found in the note section of each slide. Please review the manuscript before giving a presentation as it contains specific details about the PVP Procedure. The manuscript extends in some parts beyond the content that can actually be covered in a real presentation. Some text slides spell out the synopsis of preceding illustrations or videos. These text slides are intended to re-emphasize take home messages. For questions or suggestions, please contact Kester Nahen, Ph.D., Laserscope Director of Professional Education and Clinical Applications, phone (408) , The presentation can directly be run from the CD-ROM. To run the presentation from a hard drive, the Power Point file (ppt) and video clips (wmv, mpg) must be copied to the same folder on the computer’s hard drive. The speakers of the computer should be turned off during the presentation as some video clips include an unrelated voice-over. The presentation was prepared with Power Point 97 on a Windows 2000 PC.

2 Trattamento GreenLight PVP
Before we go into the details of the procedure, let me show you some short video clips of a GreenLight PVP Procedure. Gland size for this video is 55 cc, treatment time was 25 min.

3 Cos’è il laser KTP Let’s now talk a bit about laser physics.

4 Fisica del laser Light Amplification by Stimulated Emission of
Radiation As many of you may know, the word LASER is an acronym that stands for Light Amplification by Stimulated Emission of Radiation. Stimulated emission is a process by which light can be generated within certain materials like crystals and gases.

5 Cavità del laser KTP KTP = Potassium-Titanyl-Phosphate Nd:YAG KTP
Specchio totalmente riflettente Specchio parzialmente riflettente Nd:YAG KTP This illustration shows the basic setup of a KTP laser. An arc lamp is used to pump light energy into an Nd:YAG laser rod. The Nd:YAG material is a synthetic crystal. The Nd:YAG laser rod releases the light energy that was pumped into it in form of an infrared beam. This beam is reflected back and forth between two mirrors. Every time the beam passes through the Nd:YAG rod, the beam‘s intensity gets amplified. Hence the term, Light Amplification by Stimulated Emission of Radiation (LASER), where stimulated emission is the physical process that occurs inside the crystal. We call this whole setup a laser resonator. What‘s special about this resonator is that there is a second crystal sitting in the path of the beam. This is a KTP crystal. KTP stands for Potassium-Titanyl-Phospate. The crystal convertes the infrared light that comes out of the Nd:YAG laser rod into green light. One of the mirrors of the laser resonator is only partly reflecting so that green light can escape. This is the beam that we then use to do our surgical procedure. Note: KTP lasers are sometimes referred to as frequency doubled Nd:YAG lasers because their light frequency is twice that of a Nd:YAG laser. For the wavelenth measurement, it means that the wavelength of a KTP laser (532 nm) is half that of a Nd:YAG laser (1064nm). Lampada KTP = Potassium-Titanyl-Phosphate

6 Caratteristiche della luce laser
Monocromatica Laser light has certain characteristics that makes it particularly interesting for medical applications. Laser light is monochromatic. That means it has only a single wavelength or color. White light, in contrast, is a combination of the rainbow colors. Because of the monochromatic nature of laser light, we can selectively target tissue structures that absorb one particular wavelength, i.e. light color. We can selectively heat-up these light-absorbing structures, blood vessels for example, by using green light.

7 Caratteristiche della luce laser
Collimata White light gets emitted in all directions, while laser light runs parallel. We call that collimated. Collimated light can be focused on small spots. It can also be delivered through optical fibers.

8 Spettro di emissione elettromagnetica
Dependent on the laser material that is used, different wavelengths can be generated. You see here a spectrum ranging from the UV on the left, through its visible part, to the infrared on the right. The lines illustrate different lasers like the Excimer laser in the UV, the KTP laser in the green, the Nd:YAG in the infrared and further out in the infrared, the CO2 laser. Also shown are absorption curves for different tissue components. Dependent on what component of the tissue we want to heat, we can choose different lasers. The KTP laser is highly absorbed by oxyhaemoglogin while infrared lasers are highly absorbed by water.

9 Interazione tessutale
We will now talk about how laser light interacts with tissue.

10 Interazione tessutale
Dipende da: Struttura del tessuto Lunghezza d’onda Potenza / Energia erogate Modo di emissione (CW, Pulsato, ecc) Manualità della fibra ottica First of all, the kind of tissue effect that we will be able to achieve depends on the tissue structure, by that I mean, if it is soft or hard tissue. The effect also depends on the laser wavelength. As I mentioned, different wavelengths get absorbed by different tissue structures. The laser tissue interaction depends on the power or energy settings. A higher power generally results in a more dramatic effect. Lasers can be operated in a pulsed mode or a continuous mode, we call the later one continuous-wave or cw mode. Pulsed lasers typically cause more of a mechanical fragmentation effect while continuous-wave lasers are able to heat-vaporize a large bulk of tissue. Last but not least, the interaction between the laser light and tissue depends on the way the light applicator, for example the fiber, is handled by the surgeon. It’s important to understand that every laser and surgical procedure requires a different fiber handling technique because of the different tissue and laser parameters listed here.

11 This illustration shows how different laser wavelengths get absorbed by water and oxyhemoglobin. In the case of a cystoscopic treatment of BPH, the illustration shows us which laser gets absorbed by the irrigant and which gets absorbed mainly by the tissue. The absorption coefficient is plotted as a function of the wavelength. A high absorption coefficient means the laser beam acts only very superficially while a low absorption means deep penetration of the particular laser beam. The KTP laser beam at a wavelength of 532nm is fully transmitted through the aqueous irrigant but highly absorbed by oxyhemoglobin in the tissue. In other words, the laser energy gets selectively absorbed by the tissue. That’s why the KTP laser procedure we are talking about today is called Photoselective Vaporization of the Prostate (PVP). The KTP laser puts the energy right where we need it, into the tissue that we want to vaporize. The Nd:YAG doesn’t show this selectively. Overall, the beam penetrates deeper into the tissue and primarily causes coagulation. The Holmium:YAG acts just the other way around. The beam gets absorbed more by the irrigant than by the tissue. Laser energy gets lost by the formation of a vapor bubble around the tip of the laser fiber. This makes the tissue removal with a Ho:YAG laser vastly inefficient. Note: The vertical scale is logarithmic, i.e. each grid line is equivalent to a change of the absorption coefficient by one order of magnitude (factor 10).

12 Profondità di penetrazione ottica
The absorption characteristic of different lasers in water and oxyhemoglobin translates to different depths to which the laser light penetrates into tissue. We call this the optical penetration depth. Shown here are the optical penetration depths for different medical lasers. The KTP laser penetrates only 0.8 mm deep into the tissue. Lasers with a longer wavelength, like the Nd:YAG, penetrate much deeper into the tissue. We will talk about the consequences of the tissue effect in a moment. The Holmium:YAG laser acts, again, superficially and the CO2 even more so. When comparing the KTP and Ho:YAG laser, please keep in mind that the Ho:YAG laser gets highly absorbed by any aqueous irrigant while the KTP laser does not.

13 Principio di base La luce colpisce il tessuto bersaglio
Immediato sviluppo di calore Fotoablazione: Tessuto fotovaporizzato (PVP) The basic mechanism of how laser light interacts with tissue is that the light hits an absorber in the tissue and generates heat.

14 Vaporizzazione del tessuto
Fiber 100°C 80°C 60°C 40°C Let‘s study in a bit more detail how a laser vaporizes tissue. What we see here is a side-firing optical fiber. The laser beam penetrates into the tissue down to a certain optical penetration depth. For a KTP laser this is the 0.8 mm we talked about. The laser light generates heat that then, over time, diffuses deeper into the tissue. hit space bar After a while, this temperature profile is generated. In the red area the tissue temperature has reached 100 degrees Celsius, i.e. the boiling point. This is the tissue that gets vaporized. The vaporization carries away part of the energy the laser put into the tissue. But there is still some heat left in the tissue. Where the temperate exeeds about 50 degrees Celsius the tissue is coagulated. Tessuto

15 Vaporizzazione del tessuto
Fiber As a consequence, we get a thin coagulation zone that allows for hemostasis. Remember the white tissue surface you saw in the video? Tissue

16 Zona di coagulazione E’ dovuta alla diffusione termica durante la PVP.
Una vaporizzazione veloce comporta un a coagulazione superficiale Una vaporizzazione inefficiente provoca coagulazione profonda. There are two important things about the coagulation zone that you should keep in mind. First, it extends beyond the optical penetration depth of the laser light. This is due to heat diffusion. Second: Vaporization carries heat away from the tissue, limiting the coagulation zone thickness. That means that inefficient vaporization results in deep coagulation. This is something that we definitely want to avoid when treating the prostate as deep coagulation causes swelling, delayed sloughing of tissue and prolonged dysuria. We will get back to this when we talk about the fiber handling technique for the PVP procedure.

17 Vaporizzazione del tessuto continua
Fiber Emissione laser Quasi-Cw Continua rimozione del tessuto The GreenLight PV System is a quasi-continuous wave laser. It sends out a continuous beam of very short laser pulses which rapidly heat and remove the tissue. This allows an efficient debulking of the prostate. Note: The GreenLight laser is called “quasi”-continuous as the beam is not fully continuous. The beam is composed of a continuous stream of very short laser pulses. Overall the beam acts as if it was continuous. Tissue

18 Storia del trattamento laser dell’IPB
Let’s quickly review the history of laser treatment of BPH to see what the advantages and disadvantages of earlier laser procedures were.

19 KTP vs. Nd:YAG Fiber 0.8 mm 10 mm Tessuto 100°C 80°C
This slide illustrates the differences between the KTP and the Nd:YAG laser. The KTP laser penetrates only 0.8 mm deep into the tissue. All the laser energy gets confined in a small tissue volume which results in fast heating and immediate tissue vaporization. The coagulation zone of the KTP laser is only 1-2 mm thick as histology studies at the Mayo clinic have shown. This reduces side effects. The Nd:YAG laser, however, penetrates up to 10 mm deep into the tissue. The laser energy is dispersed over a large tissue volume. The heating is inefficient and doesn’t result in significant vaporization. Due to the deep heating, deep coagulation necrosis is induced which results in severe side effects including excessive edema, long catheterization, delayed sloughing of necrotic tissue and prolonged dysuria. This long side effect profile has led to the wide abandonment of the VLAP procedure. Tessuto

20 KTP vs. Ho:YAG Fiber Tessuto
This illustration shows a direct comparison between the KTP and Holmium:YAG laser used with a side firing fiber. press space bar to start animation. The Holmium:YAG beam gets highly absorbed by water as mentioned earlier. Thus a Ho:YAG laser pulse first heats up the irrigant and forms a vapor bubble around the laser fiber. Only after the bubble has reached the tissue can the laser directly interact with the tissue. As a consequence, only part of the laser energy is available for tissue vaporization. If the fiber is too far away from the tissue and the bubble doesn’t make it to the tissue surface, you don’t get any tissue effect at all. The green light of the KTP laser however, gets fully transmitted through the irrigant and efficiently vaporizes the tissue. Another difference between the two lasers is that the Holmium:YAG is a pulsed laser while the KTP is a continuous wave laser. The Holmium:YAG delivers energy only for a short period of time. The KTP constantly delivers energy which results in a constant and hence fast tissue removal. Studies have shown that the Ho:YAG laser side firing procedure is limited to prostates of less than 40 g. Tessuto

21 Enucleazione laser della prostata (HoLEP)
Il tessuto adenomatoso viene resecato, poi morcellato. Problemi: Lunga curva di apprendimento (>50 casi) Richiede molto tempo (50gr – 2ore) Rischio di perforazione della vescica con il morcellatore For bigger glands, you have to use the Ho:YAG laser enucleation technique. The enucleation technique uses a bare optical fiber to first resect, and then mechanically morcellate chunks of tissue that have been cut out of the prostate lobes and pushed into the bladder. There are several disadvantages to this procedure. It’s known to have a long learning curve. It’s a lengthy procedure due to the fact that it needs two steps, cutting and morcellation. There is also a high risk of bladder wall perforation from the morcellator. A recent study from Italy reported bladder injuries in almost 9% of both early and late cases in a 16 month study of 155 patients. A study from Japan published in the Journal of Urology came to the conclusion that the learning curve of the Ho:YAG laser enucleation technique is about 50 procedures.

22 Holmium Laser Ablation of the Prostate (HoLAP)
Fibra ottica ad emissione laterale Inefficiente vaporizzazione del tessuto Una parte dell’energia laser è assorbita dall’acqua.(bolle di vapore) Per prostate < 30 g; Trt. Molto lento. Le bolle di vapore ostruiscono la visibilità.

23 Coagulazione Laser Interstiziale (ILC)
Coagulazione del tessuto prostatico senza interessamento dell’uretra Problemi: Nessun controllo visivo della profondità di penetrazione Il forte edema prostatico porta a ritenzione Cateterizzazione lunga Necrosi coagulativa ritardata elevata The Interstitial Laser Coagulation (ILC) that uses a diode laser and a bare optical fiber aims at coagulating prostatic tissue while initially preserving the urethra (Indigo laser). A fiber is inserted into the lobes at several points and the tissue is coagulated. The effect is similar to that of other thermal therapies like TUNA and TUMT. The patient has to wait for the coagulated tissue to slough off before he can see an increase in flow rate. During the phase of post-operative edema, patients typically have to wear a catheter.

24 Nel trattamento dell’IPB
The GreenLight PVP Workshop PowerPoint Presentation gives an overview of how a KTP laser works, how different lasers generate different tissue effects, and why a high power KTP laser is the ideal tool to treat BPH. The Photoselective Vaporization of the Prostate (PVP) procedure is explained. The presentation closes with clinical data of a multi-center study and a single center long-term durability study. The presentation is designed as 60 minute workshop didactic. It should be supplemented by a lecture on laser safety included in the file “GreenLight PVP Workshop Presentation – Laser Safety Supplement” We encourage urologists to include their own experience in the presentation. Sample slides can be found at the beginning and end of the presentation. These slides can easily be customized by replacing the placeholders “<>” with specific information. The slides entitled “Personal Experience” are hidden by default. To show them in the presentation, select the slides and select the “Hide Slide” button in the Slide Show pull-down menu. To give presenters some guidance in how to narrate the slides, a manuscript was prepared that can be found in the note section of each slide. Please review the manuscript before giving a presentation as it contains specific details about the PVP Procedure. The manuscript extends in some parts beyond the content that can actually be covered in a real presentation. Some text slides spell out the synopsis of preceding illustrations or videos. These text slides are intended to re-emphasize take home messages. For questions or suggestions, please contact Kester Nahen, Ph.D., Laserscope Director of Professional Education and Clinical Applications, phone (408) , The presentation can directly be run from the CD-ROM. To run the presentation from a hard drive, the Power Point file (ppt) and video clips (wmv, mpg) must be copied to the same folder on the computer’s hard drive. The speakers of the computer should be turned off during the presentation as some video clips include an unrelated voice-over. The presentation was prepared with Power Point 97 on a Windows 2000 PC.

25 Caratteristiche del laser KTP
Totalmente trasmesso attraverso l’acqua (nessuna perdita di energia nella fisiologica) Assorbito dall’emoglobina selettivamente Coagulazione superficiale 1-2 mm Il laser KTP è ideale per la rimozione del tessuto molle in immersione. What makes the green light of the KTP laser unique is that it‘s beam is fully transmitted through water, i.e. no energy gets lost in the irrigant and that the energy is selectively absorbed by hemoglogin inside the tissue. The tissue gets selectively heated and vaporized by the KTP laser beam. What remains after the tissue has been vaporized is a thin coagulation zone of only 1-2 mm thickness that allows for hemostasis. These charactieristcs make the KTP laser an ideal tool for soft tissue removal in an aqueous environment.

26 Nome della procedura Photoselective Vaporization of the Prostate PVP
Because of the selective targeting of the tissue and the oxyhemoglobin in particular, the procedure is called Photoselective Vaporization of the Prostate or PVP.

27 Vaporizzazione del tessuto
Let‘s now take it a step further and look into the microscopic picture of how the KTP laser vaporizes tissue. The annimation has to be forwarded manually by skipping to the next slide. Every step has to be explained.

28 Vaporizzazione del tessuto
We zoom into the microscopic tissue structure and...

29 Vaporizzazione del tessuto
Matrice Acqua Vaso sanguigno ...picture the tissue as composed of a collagen tissue matrix, tissue water and blood vessels that sit inside these collagen cells.

30 Vaporizzazione del tessuto
When the green KTP laser light hits the tissue, it gets slectively absorbed by the oxyhemoglobin inside the blood vessels. The vessels heat up and when their temperature reaches the boiling point, vapor bubbles form around the blood vessels.

31 Vaporizzazione del tessuto
As we keep the laser beam on the tissue, i.e. we put more and more laser energy into the tissue, more and more vapor bubbles form. Pressue builds up inside the tissue. At a certain point, the vapor pressure exceeds the ultimate tensile strength of the collagen matrix. The matrix breaks apart, it bursts and we see small tissue particles and vapor bubbles being released from the tissue surface.

32 Vaporizzazione del tessuto
Once the uppermost tissue layer is removed, a new layer is directly exposed to the laser beam. Heating and pressure build-up inside the tissue continues. The next layer gets vaporized and so the “ vaporization front“ progresses deeper and deeper into the tissue. The release of tissue particles and bubbles are a sign of efficient vaporization.

33 Vaporizzazione del tessuto

34 Vaporizzazione del tessuto

35 Velocità di vaporizzazione
Dipende dalla composizione tessutale: Tessuto fibroso => vaporizzazione lenta Tessuto edematoso => vaporizzazione veloce Those illustrations also help us to understand how the speed of tissue vaporization depends on the tissue composition. If the tissue has a high fiber content, in other words the tissue has a higher ultimate tensile strength, a higher pressure has to build up inside the tissue before the tissue matrix breaks up and vaporization starts. On the other hand, if the tissue has a high blood content, then the laser energy is better absorbed by the tissue (due to the attraction of the KTP/532nm wavelength to oxyhemoglobin) and the vaporization happens faster. You will recognize the dependence between tissue composition and vaporization speed when you treat different glands. Very fibrous glands, for example, post Proscar treatment, take longer, while slightly irritated glands post catheterization vaporize faster. Note: If a patient wasn’t taking a 5-alpha reductase inhibitor like Proscar, don’t start giving it pre-op. This drug reduces the vascularity of the tissue, makes it more fibrous and thus reduces the vaporization efficiency.

36 La procedura We will now go through a GreenLight PVP Procedure step by step.

37 Indicazioni Vedi TURP Recidive TUNA, TUMT, ILC, WIT
Terapia medica inefficace Ostruzione del lobo mediano Ghiandole > 200gr sono state trattate con successo Indications are the same as for a TURP. You can treat patients who have failed a thermal therapy such as TUNA, TUMT, ILC or WIT. Some patients may show some scar tissue after a thermal therapy. In these cases, the vaporization may take a little bit longer due to the higher stiffness of the tissue. But it‘s all do-able. Patients who failed medical therapy are also candidates. There are no restrictions on gland geometry. Median lobe obstruction can be treated. Even glands much larger than 200g have been treated successfully. The treatment time, of course, increases with the gland size. You should definitely not try treat a big gland as one of your first cases as this requires some experience with the PVP procedure.

38 Dove si esegue il trattamento
Day hospital ospedaliero Ricovero ospedaliero Ambulatorio attrezzato per l’anestesia The site of service: The PVP procedure can be performed in a hospital outpatient facility, an ambulatory surgical center and in a well equipped office with anesthesia availability.

39 Preparazione PVP Quella di una normale IPB Terapia antibiotica
Sospendere gli anticoagulanti a discrezione del medico. The pre-procedural preparation is a normal BPH work-up. You may give some antibiotics and discontinue anticoagulants if feasible. Patients on anticoagulants have been treated successfully.

40 Anestesia Generale Spinale Blocco prostatico
For anesthesia, general and spinal are commonly used. If you are familiar with the prostatic or pudendal block, you can use one of those too but only in combination with MAC.

41 Regolazione della potenza
Vaporizzazione: 80 W Coagulazione: 30 W The laser power defaults to 80 Watts. This setting should be used as a standard to vaporize tissue. Don‘t start with lower power as this will reduce the vaporization efficiency and increase the coagulation effect. To coagulate a bleeder, reduce the power to 30 Watts. At this power, barely any vaporization will occur. All the heat that is generated by the laser will stay inside the tissue and coagulate it. There is another technique to coagulate bleeders and that is to increase the distance between the fiber and the tissue. We will talk about that in a second.

42 Cistoscopio a flusso continuo
Canale operativo (fibra ottica) Terminale lungo Ottica 30° Otturatore ottico sempre consigliato Now, let‘s discuss the instrumentation needed. A continuous flow laser cystoscope should be used. Laserscope has extensively evaluated instruments from different vendors. Your Laserscope representative can provide you with a list of recommended equipment. The instrument should have a size of at least 22.5 Fr. to achieve sufficient irrigation. The approved cystoscopes have a working port/fiber channel and a long beak. The long beak is needed to retract contralateral lobes and make room for the fiber. Resctoscopes can‘t be used for the procedure because the fiber gets burried between the protatic lobes. You wouldn‘t have visible control over the fiber position. You wouldn‘t see what you are firing at. A 30 degree lens should be used as it allows you good visualization of the bladder neck and trigone area in particular. Technically, the bladder neck is the most critical part of the procedure. You must keep the laser beam on the median bar and avoid hitting the ureteral orfices. Please remember to use a blunt or visual obturator. The long beak that sits at the tip of the cystoscope can otherwise cause severe damage to the urethra which can lead to intra-operative bleeding just from the instrument. Be careful not to cause false passages with the beak.

43 Filtro Video Camera Viene inserito fra ottica e telecamera per proteggere il CCD A special piece of equipment is the video camera insert. This is a small disk with an optical filter is placed between the telescope and the camera to protect the CCD chip in the camera from the high intensity laser light. It prevents the camera from getting “blinded“ and damaged. (Think of this as safety eyewear for the camera.)

44 Irrigazione Raffredda il terminale della fibra
Elimina le bolle ed i frammenti residui Usare massima gravità ingresso ed uscita aperta. Continuous irrigation is used to cool the fiber cap and to flush vapor bubbles and tissue particles away from between fiber and tissue. The fluid where the beam goes through always has to be clear so that the laser light doesn‘t get absorbed or scattered before it reaches the tissue. Use maximum gravity inflow and full outflow to achieve a good flushing effect. You may need to partially close one of the valves to balance in- and outflow.

45 Fluido di irrigazione Soluzione fisiologica Si
Glicina/Sorbitolo No si caramellizza sulla fibra As irrigation fluid, Laserscope recommends saline. Although sterile water has been used sucessfully in many studies without reports of fluid uptake, Laserscope recommends saline as it gives a better safety margin especially for very long cases. Don‘t use glycine or one of its substitutes like sorbitol as the sugar caramelizes on the fiber tip and damages the fiber.

46 GreenLight ADDStat™ ADD = Angled Delivery Device
Fibra da 600 µm con terminale di 1800 µm The laser light is applied through an optical fiber called the GreenLight ADDStat™ where ADD stands for Angeled Delivery Device. The fiber has a 600 micrometer core diameter and is equipped with a 1800 micrometer quartz cap. The cap is used to protect the fiber end that is polished under an angle to deflect the laser beam to the side. The beam has a forward deflection of 70 degrees and a divergence angle of 15 degrees. The divergence angle measures the opening of the cone.

47 Indicatori della fibra
Devono essere visibili per proteggere la fibra e lo strumento dal raggio Uscita del raggio a 180° rispetto il triangolo These are magnified pictures of the fiber tip. Point on quartz-cap end of fiber where the beam comes out, shrink tube that holds the cap in place. It‘s important to know that the laser beam is powerful enough to damage a telescope or even melt a metal sheath. To make sure you have full control over the direction the laser beam is firing, the fiber is equipped with indicators. There is a blue triangle on the cap that is located at the opposite side of where the laser beam is coming out. If you see the triangle through the telescope then the laser beam is firing away from the beak. That‘s the way it should be. If you see the red stop sign then the beam is firing into the metal beak. In the worst case, if the fiber is retracted too far into the sheath, the laser beam hits the telescope and damages it.

48 Posizione della fibra Il triangolo deve essere visibile in endoscopia
The marker on the cap has a second function and that is to indicate you how far the fiber has to stick out of the sheath to avoid damage to the cystoscope. The blue marker must always be visible to be safe. Please let your nursing staff assist you in looking out for the blue triangle. Ask them to signal when the triangle isn‘t visible. This helps you protect your instruments. This can be quite an issue especially during your first cases. (Note: The blue triangle appears to be green when you wear the orange-tinted laser safety goggles.) Il triangolo deve essere visibile in endoscopia

49 Controllo della direzione del raggio
What you see here is the knob that sits fixed on the fiber and is used to manipulate the device. The small indicator on the knob is oriented in line with the laser beam, i.e. it sits in the direction of the laser beam. Use your index finger to get a tactile feedback for the beam direction. Il raggio è in linea con l’indicatore

50 Uso della fibra Emphasize the following:
procedure starts at the bladder neck. red aiming beam. make sure you see the spot where the aiming beam hits the tissue before you fire the laser. tissue is evenly removed by sweeping the laser beam over the lobe. sandstorm of vapor bubbles and small tissue particles indicates an efficient tissue removal. GO FOR THE BUBBLES! If you don‘t see bubbles then you induce coagulation. Stop the laser after a few seconds to gauge the tissue defect. After the capsular fibers at the bladder neck have been reached, move on towards the veru to vaporize the next tissue segment. To gain speed finish up one area before moving on. Use same landmarks as with a TURP.

51 Rotazione della fibra This clip shows the laser in action and how to handle the knob on the fiber. Point at knob.

52 Distanza di lavoro 0.5 mm = 1/3 cap diameter
The most important parameter when performing the PVP procedure is the working distance between fiber and tissue. That‘s because the beam coming out of the fiber is divergent, it spreads out. When the fiber is held close to the tissue, the beam forms a small spot on the tissue. All laser energy is focused on this small area. The tissue heats and vaporizes quickly. Efficient tissue removal is achieved. At this point, the white coagulation zone is minimal. When the distance between the fiber and tissue is increased, the beam spreads out over a larger and larger tissue area. The energy gets more dispersed. Heating of the tissue slows down. The vaporization efficiency drops. At a certain distance, vaporization will stop. At this point, the laser acts in a purely coagulative manner. The schematic shows how, by increasing the working distance, the coagulation zone thickness increases and the vaporization effect decreases. In other words: Less vaporization means more coagulation. Normally we want to avoid deep coagulation as it causes edema and delayed sloughing of tissue. But, if a bleeder is encountered, moving the fiber away from the tissue can be used to achieve hemostasis. How do you contol the working distance? The working distance is adjusted by the maneuvering the cystoscope. Before you fire the laser, always make sure you have the fiber the right distance from the tissue. Keep in mind that any mechanical forces put on the handling knob of the fiber will not change the position of the fiber tip relative to the tissue. Instead you run the risk of breaking the fiber. The ideal working distance is about half a milimeter. That is a third of the diameter of the cap. In other words the fiber is used in „near-contact“mode. 0.5 mm = 1/3 cap diameter

53 Uso di fibra difettosa

54 Degradazione della fibra
Cause Eccessivo contatto con il tessuto Uso della fibra sporca Diagnosi Il raggio guida è diffuso Vaporizzazione lenta Azione Sostituire la fibra Prevenzione Evitare il contatto con il tessuto Pulire la fibra

55 Tecnica di vaporizzazione
Le bolle sono indice di vaporizzazione Un’eccessiva distanza dal tessuto aumenta la coagulazione e non la vaporizzazione. La mancanza di bolle significa problema !! What tells you that you’re using the right vaporization technique is the formation of a lot of vapor bubbles. When you don’t see bubbles, you are either too far away from the tissue or the tissue is very fibrous like at the capsule. A greater distance between fiber and tissue results in coagulation and no vaporization. The lack of bubbles means trouble as the laser energy diffuses deeper into the tissue causing deep coagulation and postoperative edema. It is important to emphasize that if the high power KTP laser is applied with too large a working distance, the side effect profile will be similar to that of the VLAP/Nd:YAG technique. If your patients are having prolonged severe dysuria after their treatment, it’s very likely that you were not close enough to the tissue or that you didn’t take out all the glandular tissue and left deeply coagulated tissue behind.

56 Velocità di rotazione Al raggio laser serve del tempo per creare l’effetto di vaporizzazione. Regolare la velocità di rotazione: Tessuto molle ghiandolare: veloce Tessuto fibroso: lento Tessuto vascolarizzato: veloce Tessuto coagulato: lento One more detail about the sweeping speed: As we learned earlier, the laser beam needs a certain time to build up sufficient heat and vapor inside the tissue for tissue removal to occur. Different tissue compositions require a different pressure to build up inside the tissue before tissue removal occurs. On soft glandular tissue you can sweep faster because less heat and vapor is required to break up a soft collagen matrix. To remove more stiff fibrous tissue, you have to sweep slower to give the tissue more time to heat and build up enough vapor pressure to break up the tissue matrix. Highly vascular tissue vaporizes faster and so you can sweep the beam faster while avascular or coagulated tissue requires a slower sweeping speed.

57 Basse Temperature 65°C -99°C
Raggio laser Tessuto Calore Basse Temperature 65°C -99°C Alte Temperature 100°C Coagulazione Edema Disuria Prolasso Vaporizzazione Rimozione del tessuto efficiente

58 Posizionare raggio guida
Posizione Cistoscopio Posizione Fibra Posizionare raggio guida Premere pedale Ruotare fibra Nessuna bolla Bolle Distanza di lavoro eccessiva Rotazione fibra troppo rapida Fibra degradata Raggiunta la capsula Tecnica corretta

59 Fiber Handling How to narrate the animation:
One of the most important aspects of the PVP Procedure is to use the right fiber handling technique. The following animation shows how to move the fiber. Lets zoom in.

60 Fiber Handling Start vaporizing tissue at the bladder neck.

61 Fiber Handling

62 Fiber Handling Rotate the fiber to evenly vaporize the tissue down to the level of the transverse fibers. The laser removes tissue layer by layer. The sweeping angle should be choosen in a way that the laser beam always stays on the tissue and doesn‘t fire parallel to the tissue surface. A 90 degree sweeping angle typically works best.

63 Fiber Handling

64 Fiber Handling

65 Fiber Handling

66 Fiber Handling Constantly turn the knob on the fiber right and left to sweep the beam over the tissue. In this way, a tissue segment is evenly vaporized.

67 Fiber Handling After the level of the transverse fibers has been reached at the bladder neck, retract the fiber and vaporize the next tissue segment down to the level of the transerve fibers. Apply the same sweeping technique.

68 Fiber Handling

69 Fiber Handling

70 Fiber Handling

71 Fiber Handling The plane established by vaporizing the first tissue segment serves as a reference plane for the vaporization of subsequent segments.

72 Fiber Handling

73 Fiber Handling

74 Fiber Handling

75 Fiber Handling

76 Fiber Handling

77 Fiber Handling After finishing one lobe, switch over to the other lobe and repeat the procedure shown before. Note: In most cases, the median lobe should be vaporized first and then the lateral lobes, one after the other, are removed. The animation only shows the treatment of two opposite lobes because of graphic limitations.

78 Fiber Handling

79 Fiber Handling Endpoint

80 Fiber Handling The endpoint of the procedure is a TUR-like cavity. The fiberous capsule should be vissible throughout the whole fossa.

81 Precauzioni Controllare sempre gli sbocchi ureterali per evitare di colpirli con il raggio laser (lobo mediano) Osservare sempre il raggio di puntamento vicino al veromontano As a note of caution: Be aware of the slight forward deflection of the laser beam especially when you work at the bladder neck. Avoid damage to ureteral orifices. Also use caution when working near the veru and sphincter to avoid damage. The speaker may note at some point that there is a bit of light coming out of the backside of the fiber. This is light that gets reflected by the optical surfaces of the fiber cap that the laser beam has to go through. The light is of low power but can blanch tissue. As the main laser beam should always be fired away from the beak of the cystoscope, the “backside beam” of the fiber will be terminated by the beak. This causes no damage to the instrument. When working on the lateral lobe near the veru, protect the veru by using the beak as a shield, i.e. rest the beak on the veru while the laser beam is firing at the lateral lobe.

82 Endpoint Creare una cavità simile alla TURP
Diminuzione della vaporizzazione in prossimità della capsula per il tessuto fibroso La loggia prostatica apparirà frastagliata in piccoli frustoli di tessuto The endpoint of the procedure is reached when a TUR-like cavity has been created. You can recognize the capsule by the diminishing efficacy of vaporization. The vaporization efficiency drops towards the capsule due to the higher tensile strength of the fibrous tissue. Remember the animation I showed you about the vaporization effect on the microscopic level. A stiffer matrix can resist a higher vapor pressure inside the tissue.

83 Controllo finale Conferma della loggia tipo TURP
Cistoscopio sul vero Chiudere l‘irrigazione Svuotare la vescica Controllo della cavità prodotta In presenza di piccoli sanguinamenti, riaprire l’irrigazione e coagulare. The final steps should be done to confirm the TUR-like cavity. Turn off the irrigation and empty the bladder. Position the scope near the veru and examin the produced cavity. While the irrigation is turned off, watch out for small bleeders. If blood leaks into the irrigant, restart the irrigation and coagulate the bleeder. It‘s important to turn on the irrigation before you coagulate the bleeder. Otherwise the laser beam would be absorbed by the blood in the irrigant and the beam wouldn‘t reach the tissue, i.e. the blood would shield the laser beam. Remember, the KTP laser beam is attracted by blood.

84 Tempo di trattamento Dipende da: Esperienza operatore
composizione tessutale dimensione e geometria prostatica E‘ corretto parlare di 50-60gr in circa un‘ora, in linea con la TURP. A few notes about the treatment time. It depends, of course, on the level of experience with PVP. Other factors are the tissue composition as mentioned earlier and the gland size and geometry. A good bench mark is a treatment time of 30 minutes for a 50 gram gland. That‘s what a multi-center study has reported. In this study, an average of 25 grams of gland weight was removed. So, you can expect to remove about 1 gram per minute. Note: Based on customer feedback, the treatment time for a PVP is about the same as for a TURP. Time constrains that do exist for TURP due to fluid uptake from the irrigant are not an issue for PVP. The user can work in a relaxed manner until the desired cavity has been created.

85 Cateterizzazione Dipende da:
radicalità del trattamento colore delle urine stato della vescica anestesia esperienza operatore L’irrigazione continua della vescica non è necessaria. Foley insertion. The speaker should report about his own practice and elaborate on how it‘s motivated. In general it should be noted that: The decision about whether to insert a foley should depend on the completeness of the tissue removal. Tissue left in place may continue to obstruct or slightly swell post-op if excessive coagulation was induced. Other factors are; clarity of the urine, status of bladder function, type of anesthesia used and the physician‘s comfort level with PVP. Typically, continuous bladder irrigation is not necessary.

86 Quando si toglie il catetere
Subito: 50% Entro 24 ore: 95% Si può valutare di lasciarlo più a lungo se: Prostata molto grossa Funzionalità vescicale compromessa Tecnica non ancora assimilata The speaker should report about his own practice and elaborate on how it‘s motivated. Please don‘t disregard the numbers given in the slide as they represent the findings of a multi-center trial. Refer to the publication (AUA 2002 abstract by Te et al.) In a multi-center trial, 50% of the patients were catheter free after the recovery room. 95% were catheter free within 24 hours. Patients with longer catheterization time had poor bladder health or other pre-existing conditions. You should consider leaving the catheter in longer if the gland is very large, the bladder function is questionable or the vaporization technique hasn‘t been fully mastered, i.e. tissue is left behind or excessive coagulation induced (due to a working distance that is too large) that could lead to swelling of the gland and obstruction.

87 Post-trattamento Antibiotici FANS (se necessari)
Analgesici (se necessari) Evitare attività pesanti e sessuali per 2 settimane Ritorno alla normale attività in 2-3 giorni Postoperatively some antibiotics should be given. Non-steroidal anti-inflammatory drugs and mild analgesics are optional. The patient should not engage in strenuous activities or sex for 2 weeks post-op. Typically patients can return to normal activities in about 2 or 3 days.

88 Curva di apprendimento
Circa casi Iniziare con ghiandole piccole (30-40 g) per imparare a: coordinare fibre e cistoscopio identificare la capsula coagulare piccoli vasi A few words about the learning curve. The speaker should talk about his/her own experience and perhaps mention what his/her level of experience with TUR or laparoscopic procedures is. The length of the learning curve given as 10 procedures on the slide is an average that Laserscope bases on customer feedback. Variations certainly exist. It‘s important to emphazise that one should start with small glands of grams to first master the coordination of fiber and scope, to learn how to identify the capsule and how to coagulate small bleeders. Once these techniques have been mastered, you can move on to bigger glands and could consider treating patients on anti-coagulants. A common comment is that PVP is relatively easy to learn but that it‘s not as easy as it looks on the video. The handling of the cystoscope is different than that of a resectoscope. The fiber is rotated, not pulled in and out of the scope. The direction of the tissue removel is, therefore, different than with a TURP.

89 Regole principali Fibra quasi a contatto (0,5mm) = ottima vaporizzazione Osservare sempre la formazione di bolle Una efficiente vaporizzazione evita coagulazione profonda Ruotare la fibra ottica Vaporizzare fino alle fibre trasversali Let me now summarize the key rules of the GreenLight PVP Procedure. Use a small working distance to efficiently vaporize the tissue. The formation of vapor bubbles indicates the vaporization effect. It‘s important to understand that efficient vaporization avoids deep coagulation. So, go for the vapor bubbles. Sweep the fiber for an even tissue removal. You should vaporize all the way down to the transverse fibers.

90 Pre-PVP This is a pre-op picture.

91 Immediatamente Post-PVP
This picture, taken immediately post-PVP, shows the capsular fiber and the typical roughness of the tissue at the end of the procedure. It may not look as clean as a TURP but...

92 3 mesi Post-PVP as you see here, 3 months post PVP, a smooth epithelial lining has formed. The small fibers that you saw immediately post-op were released the first days and weeks after the procedure. The speaker may want to mention at this point that the sloughing of the thin coagulated tissue layer can cause some mild hematuria. A few drops of blood can be seen in the urine when the dead tissue sloughs off and the tissue underneath isn’t fully epithelialized yet.

93 Dati Clinici Several studies on the PVP procedure have been performed. I would like to show you the results of a short and a long-term study that have been published and that you will find in the both the literature pack and the training manual.

94 Studio Multicentrico con GreenLight PV
Alexis E. Te Terrence R. Malloy Barry S. Stein James C. Ulchaker A multi-center prospective study was performed at several institutions in the US. They were: Cornell University, New York; Pennsylvania Hospital in Philadelphia; Brown University in Providence, Rhode Island; Cleveland Clinic; Oakwood Annapolis hospital near Detroit; and the Mayo Clinic in Rochester, Minnesota. Unyime O. Nseyo Mahmood A. Hai Reza S. Malek

95 Inclusion Criteria Symptomatic BPH requiring surgical intervention
AUA-7 score >12 Q-Max < 15 ml/sec (voided vol. of 125 ml) Duration of obstructive symptoms >3 months Prostate size g Inclusion criteria for this study were that the patients had to be symptomatic with BPH requiring surgical intervention. They had an AUA Symptom Score of more than 12 and a Q-max of less than 15 ml/sec on a voided volume of 125ml. The duration of the obstructive symptoms must have been more then 3 months. Gland sizes of 15 to 200 grams were included in the study. That means the study included patients beyond the profile of a regular TUR.

96 Risultati dello studio
139 pz trattati 119 pz (86%) trattati in regime out-patient (< 23 h) Volume medio prostata pre-trt.: 55.1±32 g Tempo medio di trt: 39 ±23 min Tempo medio di rimozione catetere: 14 ±15 h Il 32% dei pz. non richiedono catetere post trt. These are the preliminary results of the study that were published as abstract of the AUA Annual Meeting, 2003. 98 of the 145 enrolled patients had been treated. 71 of them were treated as out-patient. Those who required hospital stay had co-morbiditys or stayed longer because of logistics of transportation. The mean pre-op prostate size was 55 grams. Mean lasing time was 36 minutes and mean catheter removal time was 16 hours.

97 AUA Symptom Score Here are the results for the AUA symptom score over a follow-up of 12 months. You see an immediate and dramatic decrease in symptom score from about 24 down to 8 after one month. The further decrease of symptom score over the course of the year is, in part, an artifact due to the decreasing number of patients followed through the 12 month period.

98 Peak Flow Rate (ml/sec)
Mean Peak Flow Rates dramatically increase post op. The results are comparable to TUR because PVP has the same surgical endpoint as a resection.

99 Post-Void Residual in ml.
The Post-Void Residual drops from 114 pre to 36 milliliter 1 month post op.

100 Mean TRUS Prostate Volume (ml.)
To check how much tissue had really been removed, the TRUS volume was measured. The gland size decreased from 55 ml pre-op to about 30 ml after 6 and 12 months. This result shows why we see such a dramatic increase in flow rate and reduction in post-void residual.

101 Complicanze Disuria transitoria breve 14%
- <10 giorni Disuria transitoria persistente 9% - >10 giorni Ematuria ritardata transitoria 14% - < 10 giorni Ritenzione transitoria % Adverse events: 14% of the patients reported some short term dysuria. It was transient in nature and resolved within 14 days without treatment. 9% of patients reported dysuria for more then 10 days. 9% of the patients reported delayed transient hematuria. When informed pre-operatively to expect a bit pinkish urine after the procedure, patients typically don’t bother. Transient retention occurred in only 4% of the patients.

102 Complicanze Incontinenza transitoria 7% Eiaculazione retrograda 36%
Disfunzione erettile 0% Infezione tratto urinario 2% Transient incontinence was reported in 3% of the patients and retrograde ejaculation in 41%. The rate of retrograde ejaculation is lower than for an electro resection which can be attributed to the higher precision of the laser when compared to the loop. Some investigators suspect that the laser doesn’t induce as much thermal damage at the bladder neck as the loop. As a consequence, less scar tissue forms and the bladder neck keeps it’s elasticity. The bladder neck closes well enough during an orgasm to allow an antegrade ejaculation. You can’t promise a patient to be antegrade after PVP but you can try to work more conservatively at the bladder neck if a patient is interested in maintaining antegrade ejaculation. There were no reports of erectile dysfunction. The laser effect is very localized and, therefore, doesn’t cause nerve damage outside the capsule.

103 Risultati a lungo termine con 60W e 80W laser KTP
Studio effettuato da: Reza Malek, M.D. Professor of Urology Mayo Clinic, Rochester, MN In addition to the multi-center study that showed an immediate and reproducible symptom relief, a long term study with 5 year follow-up has already been finished at the Mayo Clinic in Rochester. Dr. Reza Malek, who first introduced the PVP technique with a 60 Watt prototype KTP laser from Laserscope, included 84 patients in this study.

104 AUA Symptom Score The results for the AUA symptom score show a long-lasting reduction. The score dropped from 22 pre-op down to 3.9 after one year and stayed stable over 5 years of follow-up.

105 Mean Peak Flow (ml/s) The Mean Peak Flow rate increased from 7.8 to 27 milliliters per second after 1 year and stayed on a high level over 5 years.

106 Lateral Lobes Obstructing Bladder Neck pre-op
Here is a picture of a 41 cc gland pre-op. The patient had a Qmax of 8.1 milliliters per second.

107 2-yr. Follow-up Mid Prostatic Fossa
This is the fossa 2 years after PVP.

108 Summary Complete vaporization of tissue Significant reduction AUA-7
Significant PFR improvement Significant reduction of PVR Low incidence of post-op discomfort Durability ~ 5 yr. results (Mayo) Let me summarize the results of the clinical studies. The high power KTP laser completely vaporizes the tissue which results in a significant reduction in AUA symptom score, a significant improvement of peak flow rate and a significant reduction of post-void residual. The studies reported a low incidence of post-op discomfort that was typically mild in nature. Clinical data from the Mayo Clinic shows the durability of the positive results of the PVP Procedure.

109 Esperienze maturate Disostruzione della prostata Minimo sanguinamento
Immediato miglioramento dei sintomi Pazienti trattati con: ritenzione urinaria in terapia anticoagulante con adenomi grossi In my personal experience the main advantages of the PVP procedure are that it allows a complete debulking of the prostate with almost no bleeding. The patients are very satisfied as they experience an immediate symptom relief. The patients that I‘ve treated include those in urinary retention and on anti-coagulants. You can treat glands of virtually any size with this technique. The largest one I did was <> cc. When you start doing PVP, make sure you get some patients with small glands at the beginning. I have to tell you that it looks easier on the video than it actually is. You have to learn a few basics before you can handle larger glands.

110 Esperienze maturate Tempo di cateterizzazione minimo
Dolore post operatorio minimo o nullo Risultati clinici What amazes me is the short catheterization time. Many of my patients…< > Some patients experience mild dysuria over the first days after the procedure but it‘s not so severe that they will call me. When they come in for their follow-up visit after a week, they have often already forgotten about it. Just council them right, i.e. tell them to expect some burning for a week or two, and they will not bother you. I was sceptical when I read Dr. Malek‘s papers about the KTP laser but today, from my own experience, I can say that my results match those of the studies.

111 Prospettive PVP concorrente a TURP Minori telefonate urgenti post trt
Alto livello di soddisfazione dei pazienti Se ne parla bene Sito internet per pazienti My perspective on the PVP procedure is that it rivals TURP and, may one day even replace this gold standard. For my personal practice, PVP has already replaced TURP. Moreover, I can treat patients that would not have been candidates for a TURP, like patients on anti-coagulants. I recieve fewer after-hours calls and see a high level of patient satisfaction. The word of mouth is very strong. <I already treated x fellows from the same x club.> What also drives a lot of patients into my practice are referrals via the internet. Laserscope has a great Website where patients can type in their ZIP code and then get referred to the nearest doctor who does PVP. Laserscope will set you up on the Web-site once you‘ve done your first 10 cases. I get about <x%> of my patients over the internet.

112 Conclusioni Sicuro – Virtualmente esangue
Tempo di trattamento simile alla TURP Non necessita di lavaggio continuo Rimozione del catetere entro 24 ore Day Surgery (riduzione costi) Il paziente può tornare a lavorare in 2-3gg Breve curva di apprendimento Let me conclude by saying that the PVP procedure can be considered safe. It’s virtually bloodless and even patients on anti-coagulants can be treated. The procedure is relatively fast with treatment times comparable to TURP. There is no need for continuous bladder irrigation and the patient is typically catheter free in less than 24 yours. PVP is an outpatient procedure which results in cost reductions. The patients can return to work within a couple of days. For the surgeon, it is a relatively short learning curve.

113 Nel trattamento dell’IPB
The GreenLight PVP Workshop PowerPoint Presentation gives an overview of how a KTP laser works, how different lasers generate different tissue effects, and why a high power KTP laser is the ideal tool to treat BPH. The Photoselective Vaporization of the Prostate (PVP) procedure is explained. The presentation closes with clinical data of a multi-center study and a single center long-term durability study. The presentation is designed as 60 minute workshop didactic. It should be supplemented by a lecture on laser safety included in the file “GreenLight PVP Workshop Presentation – Laser Safety Supplement” We encourage urologists to include their own experience in the presentation. Sample slides can be found at the beginning and end of the presentation. These slides can easily be customized by replacing the placeholders “<>” with specific information. The slides entitled “Personal Experience” are hidden by default. To show them in the presentation, select the slides and select the “Hide Slide” button in the Slide Show pull-down menu. To give presenters some guidance in how to narrate the slides, a manuscript was prepared that can be found in the note section of each slide. Please review the manuscript before giving a presentation as it contains specific details about the PVP Procedure. The manuscript extends in some parts beyond the content that can actually be covered in a real presentation. Some text slides spell out the synopsis of preceding illustrations or videos. These text slides are intended to re-emphasize take home messages. For questions or suggestions, please contact Kester Nahen, Ph.D., Laserscope Director of Professional Education and Clinical Applications, phone (408) , The presentation can directly be run from the CD-ROM. To run the presentation from a hard drive, the Power Point file (ppt) and video clips (wmv, mpg) must be copied to the same folder on the computer’s hard drive. The speakers of the computer should be turned off during the presentation as some video clips include an unrelated voice-over. The presentation was prepared with Power Point 97 on a Windows 2000 PC.


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