Surgical Guide
88 Pages
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Surgical Guide
bPh hP
Table of Contents Introduction... 4 GreenLight HPS™ Physician Training Policy... 5
SECTION ONE – SYSTEM OVERVIEW... 7
System Overview... 8 How HPS™ differs from GreenLight PV™ System... 9 GreenLight HPS™ vs. PV™ Surgical Laser Systems... 11 First Case Selection and Scheduling... 15 Procedure Essentials... 17
SECTION TWO – PRE-INTRA- POST-PROCEDURE... 23
Pre-Procedure Guidelines... 24 Supplies Needed for PVP... 25 Procedural Steps... 30 Post-Procedure... 38 Keys to Successful Clinical Outcomes... 40
SECTION THREE – CONSIDERATIONS, SAFETY AND TROUBLESHOOTING... 41 Complications and Risks... 42 GreenLight HPS™ Laser Safety... 52 Troubleshooting... 55 Procedural Problems... 55 Equipment Problems... 59
SECTION FOUR – Support Materials... 61 Support Materials... 62 Supplies Needed... 63 Laser Log... 64 Pre-Procedural Patient Instructions... 65 General Post-Procedure Instructions... 66 GreenLight HPS™ Space and Power Requirements... 67 GreenLight HPS™ Operating Room Readiness Survey... 68 GreenLight HPS™Electrical Service Requirements... 70 Table of Contents continues on Next Page...
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SECTION FIVE – Laser Training... 71 GreenLight HPS™ Laser / Tissue Interaction... 72 GreenLight HPS™ vs. Other Lasers... 75 Instrumentation and Application of the GreenLight HPS™ Laser... 80
References... 84 GreenLight HPS™ Procedure Training Quiz... 85
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Introduction Welcome to the GreenLight HPS™ laser system Surgical Guide. This handbook is part of AMS’s comprehensive training program for the Photoselective Vaporization of the Prostate (PVP™) Procedure for the treatment of BPH. The GreenLight HPS™ laser system is a high power 532nm laser system designed to efficiently vaporize soft tissue in a hemostatic fashion. AMS is committed to providing quality training to physicians and health care professionals on the use of its products and accessories. Our commitment is reflected in the GreenLight HPS™ Physician Training Policy (page 5) of this Surgical Guide. We hope you will find the GreenLight HPS™ Surgical Guide informative. If you have further questions, please contact Customer Service at 1-800-328-3881 in the U.S and Canada, international customers dial 001-952-930-6000.
Disclaimer AMS provides this Surgical Guide in its commitment to help facilitate consistent positive clinical outcomes, and to reduce patient risk and injury. The guidelines given in this Surgical Guide are not, however, intended to in any way replace or substitute a physician’s duty of care, professional responsibility, or professional judgment, nor are they intended to provide any warranty, promise, guarantee, assumption of risk or duty, release or indemnity. Physicians shall at all times maintain responsibility for patient treatment and outcomes, and AMS further assumes no liability for patient treatment or outcome or for physician’s negligence, breach of duty of care or malpractice.
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GreenLight HPS™ Physician Training Policy Consistent with the commitment to good clinical outcomes, AMS requires that all physicians undergo product and procedural training in the use of the GreenLight HPS™ laser system and performance of the PVP procedure prior to laser acquisition and first cases. A Training Completion Certificate is issued to a physician after attending a didactic session with observation of live cases and/or a wet-lab and completion of his/her first three (3) procedures proctored by an AMS Clinical Educator or AMS-certified HPS trainer. Physicians can present certificates signed by the clinical educator to their health-care facility as evidence for completion of training on the GreenLight HPS™ laser system and the PVP procedure. First cases must be supported by a AMS certified clinical educator or AMS-certified HPS trainer. The GreenLight HPS laser system training process is composed of the following steps: 1. Physicians are strongly advised to study and review the GreenLight HPS™ Surgical Guide prior to first cases, workshops, or wet-lab training sessions. 2. Physicians must attend an AMS-approved workshop, lecture or one-on-one training performed by an AMS Clinical Educator or AMS certified preceptor on the PVP procedure and the safe and effective use of the GreenLight HPS™ laser system. The workshop/preceptorship may consist of a didactic portion and participation in a wet-lab on an animal model such as a bull prostate. 3. An AMS Clinical Educator or a AMS-certified Trainer will be required to attend your first few cases with GreenLight HPS. a. A Certificate of Training Completion will be issued only after the physician has successfully completed a minimum of three cases in the presence of an AMS Clinical Educator or AMS-certified Trainer/Proctor. b. A minimum of three patients should be scheduled for the first day of GreenLight HPS procedures. c. No other Training Certificates are valid for GreenLight HPS use.
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Training and Fiber Shipping Logistics 1. First HPS cases must be done with an AMS clinical representative whether a direct, LLC or mobilized account. 2. AMS representative will carry fibers into hospital and be present for all first cases. 3. Once trained, (three cases minimum) the physician will receive an AMS-issued Certificate of Training Completion form. 4. Letter will be sent/hand delivered to hospitals explaining this procedure. 5. Once the physician is trained, the hospital or mobile provider/LLC may stock fibers but only AMS-trained physicians will be authorized to perform the procedure. 6. The responsibility for enforcement of this policy resides with hospital Risk Management and the Department of Surgery, the service provider and AMS. 7. Each month the mobile provider/LLC partner will provide AMS with a report detailing information about the hospital/physician where the fibers are being shipped.
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Section One System Overview
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System Overview GreenLight HPS™ Laser System The GreenLight HPS™ laser system is a diode-pumped, frequency-doubled Nd:YAG solid state laser. The laser system delivers a visible 532nm laser light with a power setting range of 20 to 120W, in 10W increments. The GreenLight HPS System does not need any special water or electrical connections. Laser energy emission and system status selection is activated through an “Ondemand” surgeon-operated, color-coded footswitch or system touch screen feature located in the laser console. The system provides audio confirmation of laser status (“READY” or “STANDBY”) GreenLight HPS™ Fiber The GreenLight HPS™ fiber is side firing; delivering up to 120W of 532nm light to tissue. The fiber is guided to the targeted tissue through the working channel of a continuous flow cystoscope. The GreenLight HPS fiber is used to cut, coagulate and vaporize tissue at a 70º forward defection angle to the fiber axis. It can rotate 360-degrees, allowing tissue access in multiple planes; and it is used in surgical applications where lateral delivery of laser energy is desired. GreenLight HPS™ fiber(s) are sterile and designed for single use only. The fiber cannot be re-sterilized.
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How HPS™ differs from GreenLight PV™ System 1. FAST VAPORIZATION The GreenLight HPS System with a maximum output power of 120W offers rapid tissue vaporization. The HPS System allows the surgeon to titrate the power based upon the individual patient tissue response. The surgeon may choose to use a lower power setting when treating smaller or more fibrous glands. When treating a larger or more fibrous gland, the surgeon may elect to use higher power settings. 2. SURGEON CONTROL – HANDS FREE MODE/SELECTION STATUS The HPS System allows the surgeon to control the laser settings: a footswitch enables the user to put the laser into “READY” or “STANDBY” modes: or to rapidly switch from VAPORIZATION to COAGULATION modes. These features are accomplished by the use of an electrosurgical unit (ESU)-type footswitch. 3. VOICE CONFIRMATION OF MODE The GreenLight HPS system provides audible voice confirmation of the status of the laser when the footswitch is engaged after the laser status has changed from “READY” to “STANDBY” modes. Additionally, there is an audible tonal difference between the vaporization or coagulation modes, as there currently is with ESU units used in surgical suites daily. 4. LOW DIVERGENCE PRECISION BEAM Improved collimation of the beam quality enables rapid tissue vaporization at a wider range of working distances. The delivery fiber design also eliminates scatter out of the back of the fiber, thus protecting vital tissue structures from inadvertent damage. 5. VAPORIZATION EFFECT ACHIEVED AT GREATER TISSUE DISTANCES The GreenLight HPS System allows for greater variability in working distance and sweep speed than was possible with the GreenLight PV System. The surgeon can achieve vaporization at distances of 3mm, thus employing a technique that is true “non-contact”. More consistent continuous vaporization can be maintained, resulting in a shortened procedure time, or enabling the surgeon to treat larger glands in less operative time than was possible with the
GreenLight PV™ System.
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6. COST EFFECTIVE FIBER CHOICES: The GreenLight HPS System has 2 delivery fibers to enable the surgeon to choose the most cost-effective fiber for the patient’s clinical needs: a. The GreenLight HPS BPH fiber (p/n 10-2090) is the best option for treating BPH patients. It has a joule guard limit of 275,000 joules. b. For patients with urethral strictures or bladder tumors, there is a GreenLight HPS fiber (p/n 10-2092) with a joule guard limit of 20,000 joules, available at a lower cost, thus making the procedure economically viable to perform either in an office or outpatient setting. 7. NO SPECIAL WATER/ELECTRICAL REQUIREMENTS The GreenLight HPS system is easily transportable from the OR to an ambulatory surgery center or to your office setting. It uses a standard 208V plug and 30A @50-60Hz. The laser is “selftapping” and adjusts to the voltage and frequency of any facility. 8. IMPROVED VISUALIZATION The GreenLight HPS system has a quasi-continuous pulse-width to virtually eliminate any flashing effect you may previously have seen on video screens. The 80W GreenLight PV laser uses a Star Pulse™ technology, which occasionally causes a flashing effect on some video monitors. This can occur when the image refresh rate of the video equipment is closely in sync with that of the Star Pulse.
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GreenLight HPS™ vs. PV™ Surgical Laser Systems A Side-by-Side Comparison TOPIC BEAM CHARACTERISTICS
HPS
PV
(High Performance System)
(Photoselective Vaporization)
The GreenLight PV The GreenLight HPS Laser System has a tighter beam fiber attains optimal vaporization at 0.5mm profile with low beam divergence, thus maintaining tissue distance. Greater tissue efficient vaporization at distances may result in tissue distances of 3 mm. coagulation of tissue, not vaporization. Same. Beam has a 70° forward deflection, like the GreenLight PV ADDStat™ fiber. Exercise caution when lasing near bladder neck to prevent inadvertent lasing of bladder wall or ureteral orifices.
WAVELENGTH
532 nm wavelength is highly Same absorbed by hemoglobin in tissue while not losing energy through irrigation fluid
FIBER DIFFERENCES
Fiber has highly reflective PhotoShield™ coating on back side (opposite the aiming beam) to prevent damage to non-targeted tissue
The PhotoShield™ coating is not available on the ADDStat™ fiber.
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TOPIC
HPS
PV
Avoid tissue contact, maximum power settings until which can cause a channel is created and you premature fiber can operate with a true “non- degradation and fiber contact” technique. failure, including shattering or cap UTILIZING MAXIMUM LASER detachment. POWER SETTINGS WHILE THE TISSUE TO FIBER DISTANCE IS <3 mm MAY RESULT IN PREMATURE FIBER DEGRADATION, POSSIBLY INCLUDING SHATTERING OR CAP DETACHMENT.
PRESERVING FIBER LIFE Do not operate laser at
If tissue is adherent to fiber, Same. put the laser in STANDBY; remove the fiber from the cystoscope and clean it away from the tip with a moistened sterile gauze. Do not clean the fiber by rubbing it against tissue. or burying it into tissue. Entrapment of laser fiber tip Not applicable. by large bubbles of hot vapor increases speed of fiber degradation.
POWER SETTINGS
AMS recommends that Maintain power the physician commences settings at 80W for the procedure at lower vaporization. To vaporization settings until the coagulate, change urologist can judge the tissue power to 30W or response to the laser, and increase distance to adjusts the power accordingly. tissue. The default vaporization setting for the HPS System is 80W. Separate footswitches are used for vaporization and coagulation (similar to an electrosurgical unit). Default coagulation power setting is 20W; this can be increased if required.
Power settings must be manually adjusted by laser operator at console.
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TOPIC POWER SETTINGS (continued)
HPS
PV
If desired, increase power setting to achieve faster tissue removal. Increase power only after channel has been created so a working distance is available between tissue and fiber.
Does not apply; maximum vaporization setting is 80W.
To avoid inadvertent damage to sensitive anatomic structures such as the bladder wall, ureteral orifices, or adenomatous apical tissue near or beyond the verumontanum, the surgeon may choose to limit vaporization settings to 80W
Same.
When treating very small glands, the surgeon may choose to use power settings less than 80W.
TISSUE DISTANCE
A true “non-contact” technique should be employed. Fiberto-tissue distance should BE APPROX. 3 mm.
Must maintain a “near contact” technique and stay 0.5 mm from tissue
Do NOT increase power settings until a good working channel has been created so that contact between tissue and fiber can be avoided
Tissue to fiber distance of >0.5 mm will coagulate tissue, resulting in dysuria, sloughing and prolonged catheterization time
Fiber to tissue distance and good irrigation flow needs to be maintained to minimize fiber degradation.
Same.
Surgeons who perform PVP Same. with the fiber in tissue contact should consider revising their technique to non-contact to avoid fiber failure.
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TOPIC COAGULATION OF BLEEDERS
FIBROUS GLANDS
HPS
PV
Use the COAG footswitch. Cauterize a bleeder by “painting the neighborhood” surrounding the bleeder using 20W. Power can be increased if needed at the discretion of the treating physician/ surgeon).
Adjust laser power to 30W, and maintain tissue distance of 0.5mm while treating the tissue around the bleeder
Vaporization of fibrous tissue can be achieved either by increasing power settings, decreasing sweep speed, or a combination of both.
Slow down sweep speed to speed up vaporization effect on tissue. A slower sweep speed allows the heat from the beam more time to penetrate fibrous tissue and heat the tissue to vaporization temperatures.
OR Defocus the beam (increase the distance between the fiber and the tissue) (increase the distance between the fiber and the tissue)
Decrease fiberto-tissue working distance.
IDENTIFICATION OF CAPSULE
The surgeon should identify capsular fibers and consider this anatomical landmark as the natural end point of the procedure.
Same.
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First Case Selection and Scheduling Learning Curve Skills acquired with other cystoscopic procedures largely apply to GreenLight HPS™. Most urologists find the learning curve for PVP is relatively short, particularly if they are experienced at performing PVP with the GreenLight PV™ Laser System. The GreenLight HPS™ procedure must be performed using a video camera system. IF YOU ARE NOT PROFICIENT AT USING A VIDEO CAMERA SYSTEM IT IS STRONGLY SUGGESTED THAT YOU BECOME PRACTICED HANDLING VIDEO CAMERAS WITH PROCEDURES YOU ARE COMFORTABLE PERFORMING (such as a TURP) prior to scheduling your first PVP procedure. Patient Selection If you have never done a PVP procedure before, we recommend selecting patients that fit the following profile for your initial cases: • Prostate gland size under 40cc AS MEASURED BY TRUS • Patients who are NOT on anticoagulants Patients with large glands, are anti-coagulated, or who have an indwelling Foley catheter due to urinary retention pose a greater surgical challenge. Choosing the proper patients for your first cases will allow you to master fiber handling and vaporization techniques. Scheduling of First Cases For your first few cases an AMS Clinical Educator or AMS-certified trainer will be present to support you and answer any technical questions that may arise, as well as remind you about the keys to successful clinical outcomes. It is recommended that you schedule 2 or 3 procedures for your first HPS procedures. Clinical educators cover large territories. Accordingly, please coordinate dates with your clinical educator in advance.
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For your first day of GreenLight PVP Procedures with the HPS System, it is recommended that you: • Schedule two or three (at most) procedures per physician • Arrange for the procedures at the beginning of your operating schedule, not following major open procedures. • Plan for an OR time of 90 minutes per case. Scheduling of Staff In-Service Education If the GreenLight HPS™ laser system is new to your facility, the AMS Clinical Educator will coordinate with the OR supervisor to include time to conduct In-Service training for the key personnel involved with operating the laser or specializing in urology. If you are using the services of a mobile laser provider, the provider will assume responsibility for in-servicing the staff of your facility. The AMS Clinical Educator will contact you to coordinate dates for In-Service training of key staff members concurrent with your first procedures. The afternoon before first procedures is an ideal time to conduct training for facility staff. Please make the key staff members available for a 60 minute time slot for the staff In-Service presentation and hands-on introduction to the GreenLight HPS laser system. In-Service Education of Facility Staff The AMS Clinical Educator will provide the staff copies of a Clinical Competency Validation Checklist (see Section 4: Support Materials) to ensure that key staff members have demonstrated the knowledge and skills required to operate the GreenLight HPS Surgical Laser System Subjects covered in the training session include: • Laser Safety • Basic understanding of the high-performance 532nm laser and tissue interaction • Complete front-to-back demonstration of the GreenLight HPS laser system including setup, use, and storage. • PVP procedure setup If you do not have the contact information of an AMS Clinical Educator please call AMS Customer Service at 1-800-328-3881 in the U.S and Canada, international customers dial 001-952-930-6000.
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Procedure Essentials Choosing Power Settings Laser parameters are selected and the system status is changed by using a touch screen. You may also use the button on top of the footswitch to go from “READY” to “STANDBY” laser status. The aiming beam is activated when the system is changed from “STANDBY” to “READY” and the surgical beam is activated by pressing the footswitch. Press the yellow pedal for “VAPOR” and the blue pedal for “COAG”. The laser provides audible voice confirmation of the laser status (“READY” OR “STANDBY”) Power is set by touching the – or + buttons on the display screen. An audible tone will be heard when maximum or minimum levels are reached. The default settings for the laser are 80W vaporization and 20W coagulation. AMS recommends that the surgeon consider titrating the laser power according to the tissue response. When treating very small glands, the surgeon may consider using power settings lower than 80W until tissue vaporization effect has been evaluated. If treating bladder tumors or strictures, the surgeon should use lower power settings Indicates Mode of Operation (Vapor/Coag) Coagulation Power Indicator
Vaporization Power Indicator Power Adjust Buttons
Power Adjust Buttons
Ready/Standby Control and Indicators
Resets Energy and Lasing Time
Energy Indicator Figure 1: The Touch Screen
Total Lasing Time
Changes the Set-up Screen (adjusting volume, screen brightness, contrast of screen)
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How To Judge Proper Sweeping Speed: The GreenLight HPS surgical laser system efficiently vaporizes tissue, as evidenced by the formation of “vapor bubbles”. Figure 2: Bubble formation indicates efficient
The GreenLight HPS laser system allows for variability in the sweep speed used by the surgeon. Vascular tissue vaporizes faster than more fibrous tissue, therefore the surgeon may choose to sweep faster, or decrease the power setting (watts) of the laser. Choosing Laser Power Settings
It is recommended that you start vaporization at 80W and adjust the power according to the vaporization effect observed. Do not operate laser at maximum power settings
until a channel is created and you can operate with a true “non-contact” technique.
UTILIZING MAXIMUM LASER POWER SETTINGS WHILE THE TISSUE TO FIBER DISTANCE IS <3 mm MAY RESULT IN PREMATURE FIBER DEGRADATION, POSSIBLY INCLUDING SHATTERING OR CAP DETACHMENT. Opening the urethral channel allows increased flow irrigation fluid into the bladder carrying the vaporization bubbles away from the visual field. At start-up, the default setting for vaporization is 80W. For smaller, more vascular glands, the surgeon may choose to remain at 60W throughout the procedure. The higher power is in reserve should you decide it is necessary to use it. Judge the effectiveness of vaporization by the formation of vapor bubbles as well as the vaporization effect of the tissue. Always keep the fiber moving to avoid forming deep holes or furrows in the tissue.
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Illuminate the Targeted Tissue The GreenLight HPS System has a tighter beam profile with low beam divergence, which permits the surgeon to maintain efficient vaporization at fiber to tissue distances of 3 mm. The aiming beam should illuminate the tissue that is planned for removal. The surgeon should visualize the tissue that is targeted for removal prior to beginning vaporization, keeping in mind that the aiming beam exits with a 70° forward deflection. The location of the ureteral orifices must be identified before lasing begins. The surgeon should exercise caution when treating the bladder neck to ensure that the laser beam does not fire into the bladder and damage the bladder wall or ureteral orifices. The surgeon should stop and evaluate the tissue effect after a few seconds. Following the procedure, the surgeon should again inspect the bladder and ureteral orifices to ensure that the laser beam has not caused unintended damage. Working Distance Improved collimation of the laser beam results in a tighter beam profile, resulting in low divergence of the laser beam as it exits the fiber. This feature allows the urologist to use greater fiber-to-tissue distances without sacrificing vaporization efficiency. The GreenLight vaporizes effectively at distances up to 3 mm. When in “READY” mode the GreenLight HPS™ laser system’s red aiming beam will be visible. Note that the size of the aiming beam (the beam “footprint”) increases as the fiber is moved away from the tissue (see figure 3).
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Contact between GreenLight HPS Delivery Fiber and Tissue Contact between GreenLight HPS™ fiber and tissue should be avoided. • Contact with tissue also encourages the adherence particles of tissue to the cap (see figure 3) • Tissue attached to the fiber will absorb laser energy and distort the composition of the cap of the delivery fiber. If tissue adheres to the quartz cap it must be cleaned off immediately.
Figure 3: Tissue on Fiber Tissue adhered to delivery fiber can act as a “heat sink” and will accelerate fiber degradation.
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