Clinical Orientation for the Applicator - Cianna Medical · Clinical Orientation for the SAVI®...
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Clinical Orientation for the SAVI ® Applicator
Transcript of Clinical Orientation for the Applicator - Cianna Medical · Clinical Orientation for the SAVI®...
Clinical Orientation for the SAVI® Applicator
Presenter
Presentation Notes
Thank you for joining us today. I would like to take the next hour to talk about the advantages of offering women the most flexible APBI delivery system and what you can expect from working with the Cianna Medical team. When you choose to work with Cianna Medical, you are entering into a collaborative partnership in which we promise to provide the most sophisticated APBI technology, education and training all designed to help you provide the very best in patient care. Nurses, therapists and technologists play a vital role in the day-to-day procedures for delivering APBI. To facilitate your expertise with SAVI, we will spend the next hour discussing information and details about; the SAVI applicator, clinical data and outcomes, patient set-up, treatment delivery, wound care, infection control and patient education. In addition, the Cianna Medical team will be onsite during initial cases for treatment planning, first fractions and device explants to reinforce the information you’ve received. Upon completion of those initial cases you will receive a certificate indicating your training is complete.
Greater flexibilityTreats the widest array of cavity & breast sizes
Enhanced performanceEliminates skin spacing restrictions
Better outcomesLowers toxicity & risk of persistent seroma
Exceptional precisionSculpt dose with selective radiation
Added convenienceSimple, secure placement and removal
The SAVI® Applicator
Presenter
Presentation Notes
SAVI combines the benefits of interstitial and balloon brachytherapy. It is the only single-entry device that enables physicians to sculpt the dose to patient-specific anatomy while sparing healthy tissue unnecessary exposure to radiation. The result is better outcomes for your patients, and greater flexibility that enables you to offer the benefits of APBI to more women.
SAVI Product Line
•SAVI Applicator•6-1Mini•6-1•8-1•10-1
•SAVI Prep Catheter
Presenter
Presentation Notes
SAVI is available in 4 different sizes, which has allowed us to treat cavities as small as 8cc and as large as 90cc. We also offer the SAVI Prep Catheter which serves as a sizing device to ensure perfect sizing and placement of the SAVI applicator for every patient. In the case of cavities larger than 60cc it is appropriate to allow time for the cavity to shrink
SAVI Size Reference Chart
Presenter
Presentation Notes
The SAVI Size Reference Chart is a tool to guide clinicians in the decision making process when choosing which size device is appropriate for the cavity they are treating. By cross referencing the dimensions of the cavity and the fill volume of the SAVI Prep Catheter, the chart will guide the physician to a particular size device. Supporting document: SAVI Size Reference Chart
SAVI Applicator Details
Presenter
Presentation Notes
Throughout this presentation I will reference specific components of the SAVI applicator. So we are all using common terminology, let’s review the various parts of the SAVI applicator. Beginning with the cone shaped tip, this is referred to as the “distal tip”. Moving proximally along the device you will see that 3 of the outer catheters have “radiopaque markers” which are used to differentiate the catheters when imaged. The white band that follows is the “proximal hub”. Ideally, everything moving distally, from the proximal hub is what will be in the patient’s cavity. The next component we encounter is a white ring that keeps the catheters gathered but can also be used as a reference point to visually judge device positioning. The white flanged portion is referred to as the “handle”. Sticking out through the center of the handle is a stainless steel stem with a white knob on the end. This is referred to as the “expansion tool”. This is a removable device that is used to expand and contract the SAVI. Coming through the center of the expansion tool is the “central catheter” and it is capped with a purple tipped “catheter protector”. Each of the outer catheters are numbered and capped with white tipped catheter protectors. Keeping these in place will provide protection for the ends of the catheters as well as keep foreign matter from entering the catheters and possibly corrupting the HDR source.
Patient Selection
• Any patient that is an APBI candidate– ABS guidelines– ASBS guidelines– ASTRO Consensus Statement
• If inserted post-op– less than 6 weeks from lumpectomy
Presenter
Presentation Notes
The physicians will continue to exercise their clinical judgment on which patients are suitable candidates for APBI using the guidelines they are already familiar with
Who is Not Now a Balloon SAVI Candidate?
• Breast size too small– A-cup & B-cup
• Lumpectomy site inappropriate– Axillary tail– Medial, parasternal– Inframammary fold– Retroareolar– Peripheral breast
• Augmented breasts
Presenter
Presentation Notes
Many patients are contra-indicated for balloon brachytherapy due to a number of anatomical restrictions. Because of the treatment planning flexibility SAVI makes possible, these patients now have access to the benefits of APBI
In Your Expert Hands, SAVI Delivers
•Lower Toxicity Profile•Better Outcomes•More Women
Presenter
Presentation Notes
Technology is not the only SAVI advantage – we invest a tremendous amount of resources in training and education. Our #1 goal is to be sure that your entire clinical team becomes SAVI Experts.
Lower Overall Toxicity Profile
• Skin and rib dose less than 100% regardless of spacing
• Lower persistent seroma rate– Peripheral multi-catheter design results in non-
contiguous V200– No tissue compression
• Open architecture design allows cavity to conform to applicator
– tissue does not stretch around a sphere• Lower infection rate
Presenter
Presentation Notes
The multiple peripheral catheters of the SAVI applicator allow for unparalleled treatment planning flexibility among single entry APBI devices. This flexibility allows your physicist to keep the dose to any critical structures close to 100% of the prescription or lower. The lower the dose to those critical structures the lower the risk of radiation related complications. The cause of persistent seroma has been postulated in several papers. A Balloon’s dose has a radial geometry, therefore the V200 is contiguous. In addition, in the larger balloon volumes, tissue is compressed. The unique, open architecture design of the SAVI applicator obviates both of those issues.
Balloon Skin Toxicity
• Recent data suggests strong correlation between max skin dose >120% and negative cosmetic outcomes– M. Wallace, et. al., William Beaumont Hospital Royal Oak, MI;
Poster session ASTRO 2008
• 9.7% of ASBS MammoSite Registry patients developed telangiectasia correlated to– 6, 7, and 8mm skin distance– Balloon fill volume ≤ 50cc– A/B bra cup size
Presenter
Presentation Notes
As you may know, skin distances of 7mm for MammoSite and 5mm for Contura are required by their instructions for use. At these distances the skin can still receive up to 145% of the dose. Data shows that skin dose greater than 120% leads to negative cosmesis. Telangiectasia is also a negative cosmetic outcome that can be eliminated or reduced by lowered skin dose. Notice the skin distance with balloons that correlates with telangiectasia. Lastly, in order to pull dose away from the skin in smaller breasts, you shift dose to the chest wall and increase chest wall toxicity.
Balloon Chest Wall Toxicity
• Recent data suggests higher incidence of late chest wall toxicity with max rib dose > 125%– L. Cuttino, et al., Department of Radiation Oncology, Virginia
Commonwealth University, Richmond, VA; Brachytherapy 2009
• 5 rib fractures in 105 patients treated with max dose of 35.8Gy– Brashears, et al., Medical University of South Carolina;
Brachytherapy 2009
Presenter
Presentation Notes
Among the greatest strengths of the SAVI applicator is its ability to minimize excessive dose to multiple critical structures simultaneousely. A and B cup patients are difficult for balloon catheters to treat because of their limited ability to control dose to one critical structure much less two. SAVI offers the ability to easily keep dose to the skin and chest wall close to 100% of the prescription dose.
What Happens After a Balloon?
Evans, et. al., Tufts-New England Medical Center, Tufts University School of Medicine Boston MA; IJROBP 2005
Presenter
Presentation Notes
Persistent seroma is a regrettable side effect that many patients treated with balloons experience. Persistent seroma in itself is not as troubling as symptomatic persistent seroma. These symptomatic seroma are painful to the patient, may require draining, biopsy and re-excision. In addition, mammography interpretation is more difficult and another modality may be required to follow the patient. It is disconcerting to the patient to still feel a lump in their breast. This is a huge issue for most surgeons. The cause of persistent seroma has been postulated in several papers: Contiguous V200 Tissue compression causing hypoxia to the surrounding tissue Both? The image on the left is mammogram of patient at 26 months post MammoSite treatment. The image on the upper right is of an ultrasound showing a well defined seroma with an irregular contour where the arrow indicates which prompted a biopsy. Finally, the image in the lower right is an excised persistent seroma. Notice the fibrous capsule.
SAVI Delivers Better Patient Outcomes
Kuske,et al.
Yashar, et al.BrachytherapyOct-Dec 2009
Yashar, et al.
2009 ASBS
Mantz, et al.
2008 ASTRO
Mantz, et al.
2008 MBCC
# of Patients 102 30 63 12 18
Median F/U 22 months 12 months 18 months 6 months 6 months
Infection Rate 2.7% 5% 3% 0% 0%
Persistent Seroma 8% 0% 0% 0% 0%
Fat Necrosis 2% 1% Not Reported 0% 0%
% of Patients< 7mm to skin
55% 33% 39% 100% 55%
Presenter
Presentation Notes
There have been over a dozen SAVI related abstracts accepted for publication and/or presentation. Most notably, Dr. Catheryn Yashar from UCSD and Dr. Robert Kuske have been following more than 100 patients with a median follow-up of 22 months. Our patient outcomes are far superior to balloon applicators with a significantly lower infection rate, persistent seroma and fat necrosis. Let me also point out that of the persistent seroma reported in Kuske, et. al., 0% of which were symptomatic. And, notice that we were able to achieve these results even though 55% of our treatment plans had less than 7 mm of skin spacing.
Clinical Case Review
PTV D90 V200 Dmax Skin Dmax Rib Dmax Lung
54cc 96.7% 11.5cc 100% 110% 75%
Presenter
Presentation Notes
This is an A-cup breasted patient with a SAVI 6-1 implanted in a very superficial cavity. The 1-cm expansion extends both outside the skin and into the chest wall. The white line is the outer PTV surface and the red line is the 100% isodose surface. Note again the excellent conformance of the prescription dose to the chest wall, skin surface and remainder of the PTV surface. Coverage was excellent in this patient who had a 14 cc cavity, and the hotspots were well below limits.
SAVI – Excellent Cosmetic Results
Presenter
Presentation Notes
Patient was seen at four weeks, post-radiation therapy, with excellent cosmetic results. Only the incision sites for the lumpectomy and sentinel node dissection are noticeable. No hyperpigmentation, atrophy, fibrosis or telangiectasia has been noted at 12 month f/u.
SAVI Procedures
1. Pre-implant CT Evaluationa. No more than 72 hours prior to implant
2. Surgeon implants SAVI3. CT of SAVI Implant
a. 24-48 hours post-implant 4. SAVI Length Measurement5. Treatment Planning6. Pre-fraction QA7. HDR Fraction Delivery BID for 5 days, 6 hours apart8. SAVI Removal
Commonly Used Supplies for the SAVI Applicator
Presenter
Presentation Notes
Now that it has been determined that the patient is going to have a SAVI implanted, let’s review the patient flow from beginning to end… We will provide you with a list of the supplies you will most likely need throughout this process. Supporting Document: Commonly Used Supplies for the SAVI Applicator
Pre-Implant CT Evaluation
1. Obtain CT scan of breast to be treated- ≤ 3 mm slices
- no gaps between slices- Patient arms up or down- Scan with breath hold if possible- Scan over the entire cavity ± 2 cm superiorly and
inferiorly2. Send CT data set to planning software3. Have MD evaluate cavity and record data
- Outline cavity margins on axial images- Determine volume (cc) of cavity- Measure the long axis (cm) and short axis (cm)- Assess the best insertion site and entry angle
Presenter
Presentation Notes
Patients being considered for APBI using the SAVI device should undergo an evaluation CT within 72 hours of the planned implant. The CT scan is to be used to evaluate the suitability of the patient’s excision cavity for accommodating the SAVI applicator. Key aspects of the cavity to review include; cavity size (linear dimensions of the cavity’s major axes), approximate volume (cubic centimeters) and the best orientation and approach angle for insertion of the SAVI applicator.
Pre-Implant CT Evaluation
4. Using data, determine the most appropriate SAVI applicator size using the SAVI Size Reference Chart
5. Communicate SAVI size and cavity/insertion parameters to SAVI Representative and the Physician who will implant SAVI
Presenter
Presentation Notes
This is a great example of a pre-implant CT where a physicist has measured the dimensions of the cavity and points out the ideal angle of entry all of which facilitates the choice of device size as well as the optimal angle of entry
CT Simulation of SAVI Implant
1. Retrieve “Expansion Tool” from patient2. Remove all dressings3. Use breast board or Vac-Lock to assist in positioning 4. Place CT laser alignment marks on patient 5. Acquire AP and Lateral scouts for daily QA6. Note position of markers on the 2, 4, and 6 catheters
Presenter
Presentation Notes
In the simulation phase of the SAVI treatment, the first task is to assess the implant for the desired expansion using CT. Marker wires are not needed. The SAVI’s size can be adjusted if desired and the patient scanned again. Scout images from the CT will be also be obtained for use in daily QA of the SAVI implant size and location. These scouts will be used to assess rotation between fractions. To assess patient set up, review consistency of bony anatomy relative to distinct parts of the SAVI. If the later scouts show significant differences from the baseline, or planning, scouts, then the patient needs to be repositioned. Once positioning is OK, review SAVI markers’ positions relative to other aspects of the SAVI device.
CT Simulation of SAVI Implant
7. Acquire planning CT data set- For 8-1 and 10-1 applicators
a. Use ≤ 3 mm slices with no gaps between slices - For 6-1Mini and 6-1
a. Use <3 mm slices with no gaps- Use same patient positioning for treatment- Scan cavity ± 2 cm superiorly and inferiorly (or whole
breast per your SOP)- True axial if feasible- Scan with breath hold if possible
Presenter
Presentation Notes
During your initial SAVI patient treatments a Cianna Medical team member will be on hand for support to insure that any questions that may arise will be answered
CT Simulation of SAVI Implant
8. Evaluate placement and expansion on CT- Physician may adjust device if necessary using
the Expansion Tool9. Measure and record* distance from skin surface to
catheter handle (axial assessment)10. Mark white ring and skin in continuous line (rotational
assessment)
Presenter
Presentation Notes
The use of the white ring as an indicator of rotation should only be used as a visual indication. Device position will be confirmed with images. Record measurements on SAVI Prescription and Treatment Summary Template
CT Simulation of SAVI Implant
10. Measure & record catheter/transfer guide tube lengths 11. Export CT to Treatment Planning Software
Pre-Fraction QA
1. Remove all dressings2. Measure distance from skin to central channel handle
a. Compare to reference value taken at planning CT3. Position patient on CT table to match original positioning4. Align marks on patient with CT simulator lasers5. Acquire AP and Lateral scouts and axial images
Presenter
Presentation Notes
It is crucial to reproduce the patients position with every pre-fraction QA to assure proper treatment in accordance with the treatment plan.
Pre-Fraction QA
6. Evaluate scouts for movement or rotation of SAVI using disk markings and scouts.
7. If changes are noted notify Physician to re-plan/reposition device if needed
8. Compare position of catheters against recorded data on SAVI Prescription and Treatment Summary Template obtained at the planning CT session
6-1 and 6-1Mini 8-1 10-1
Presenter
Presentation Notes
Supporting Documentation: SAVI Prescription and Treatment Summary Template
Pre-Fraction QA
Rotation assessment using scouts
Presenter
Presentation Notes
The lateral scout on the left was obtained at the planning CT session and is the baseline. The scout on the right was taken as pre-fraction QA image. The arrows point to features common to the two images. The relative positions of the SAVI structures relative to the SAVI device and bony anatomy are all consistent indicating excellent repositioning (patient setup) and no device rotation between imaging sessions. This should be done with both the AP and lateral scouts if they are of sufficient clarity and quality.
HDR Fraction Delivery
1. In HDR suite, duplicate patient position from planning CT
2. Remove purple catheter protectors, place in basin3. Insert Expansion Tool over central catheter and
engage4. Confirm all connections between SAVI catheters,
transfer guide tubes and afterloader5. Secondary check of all connections for correct
numbering6. Keep transfer guide tubes as straight as possible7. Follow SOPs for fraction delivery8. Disconnect Transfer Guide tubes from SAVI
Presenter
Presentation Notes
3. Any time you are handling/ Manipulating the expansion tool be careful not to turn the tool once it has been engaged. This could � potentially effect the position of the device 4. For GammaMed/Varian afterloaders take caution not to over-tighten connectors which may damage the catheter ends 6. The additional weight of the transfer guide tubes has the potential to effect the position of the device. When all of the transfer guide tubes have been connected consider providing support for the additional weight to maintain the intended device position. A table to support the tubes or a towel rolled and placed beneath the device are two ways to achieve this
Emergency Removal of Device
• In the event the source does not retract and device must be removed emergently:a. Ensure Expansion Tool is engagedb. Turn Expansion Tool counter clock-wise until click is heard or
feltc. Rotate SAVI in either direction releasing it from tissued. Remove device and insert in bail out pig
• See “Emergency Removal Procedure for the SAVI Applicator” located in Medical Physics Implementation binder
Presenter
Presentation Notes
The focus here is removing the device quickly. Step C is to ensure that the device is free of tissue and will not hurt the patient as it is being removed Supporting Documentation: Emergency Removal Procedure for the SAVI Applicator (LIT0129A) located in Medical Physics Implementation Binder
Site Dressing for SAVI
1. Replace Catheter Protectors
2. Slide white disc away from skin
3. Cleanse entry site with antiseptic
4. Allow antiseptic to air dry
5. Apply antibiotic ointment to insertion site
Presenter
Presentation Notes
As with any indwelling device, keeping the incision site clean is of the upmost importance. Because the open architecture design of the SAVI applicator, you may see more drainage throughout the treatment compared to what you are use to seeing with the balloon devices. The balloon can have a tamponade effect which may trap fluid inside whereas the SAVI allows drainage and may provide some explanation for our lower infection and persistent seroma rates.
Site Dressing for SAVI
6. Place drain sponges around base of SAVI at incision site
7. Wrap exposed portion of SAVI in ABD pad
Presenter
Presentation Notes
You can use your standard wound care technique, but I would like to point out a few key steps. The preferred placement of drain sponges is to use at least two sponges with the slits facing in opposite directions. Notice the slit is pointed down in the top illustration and it will be facing up on the bottom illustration.
Site Dressing for SAVI
• Care must be taken not to bend the central shaft or any of the treatment catheters beyond 90 degrees
• Bending beyond 90 degrees can result in damage to the central shaft.
Presenter
Presentation Notes
When dressing patients after implantation and between fractions, care must be taken not to bend the central shaft or any of the treatment catheter beyond 90 degrees. The top image is an example of proper bending techniques while the bottom image demonstrates bending beyond 90 degrees.
Site Dressing for SAVI
8. Cushion as necessary for comfort, put bra on and close to hold dressing in place
9. Send patient home with Dressing Change Instructions
Presenter
Presentation Notes
A front closure bra provides excellent support and holds the dressings in place. Wal-Mart carries an affordable sports bra that many facilities recommend. The cost is roughly $8 Supporting Documentation: Dressing Change Instructions for the SAVI Applicator
Patient Instructions
• While under treatment, pt should notify Physician ifa. Fever over 100.5 degreesb. Painful, red, or swollen along area of implantc. Excess bright red drainage at site
• Mild analgesic such as ibuprophen, if needed• Keep bra on at all times• Do NOT shower with applicator in place• Dressing change instructions over weekend, if desired• Do not torque device disturbing it’s position
Presenter
Presentation Notes
The patient instructions are similar to those for any APBI device. The patient should not shower or get the dressing wet. The patient should wear a bra at all times, taking care in day to day activities not to put direct pressure on the device or torque the portion outside the body. Both of these can cause the device to shift position which may require development of a new treatment plan.
Removal of SAVI
• DO assure that expansion tool is seated before attempting to collapse
• DO NOT attempt to collapse applicator with expansion tool un-seated
Presenter
Presentation Notes
After treatment is complete, the SAVI applicator is removed in simple, straightforward process. For this removal process, proper use of the expansion tool to collapse the applicator is essential. The expansion tool must be fully inserted and firmly seated into the nut/thread mechanism before attempting to collapse the applicator. DO NOT attempt to manipulate the applicator with expansion tool un-seated. Applying upward or downward pressure on the expansion tool may damage device.
Removal of SAVI
1. Apply anesthetic cream/gel to insertion site prior to last fraction
2. Partially collapse SAVI by turning expansion tool counterclockwise
3. Hold SAVI close to insertion site, turning it left and right until it turns freely
Presenter
Presentation Notes
The key to rotating SAVI is to free the device of tissue. Some suggest 90 degrees, 180 degrees 360 degrees Placement of the free hand on the breast, over the device may provide resistance and facilitate the freeing of the catheters from tissue Supporting Documentation: SAVI Removal Guide
Removal of SAVI
4. Fully collapse SAVI by turning expansion tool counterclockwise until “click” is heard or felt
5. Turn the entire device again, checking that it moves freely then slide it out of the breast
6. Apply pressure to breast to express any seroma in the cavity and dress the insertion siteRemoval Guide for the SAVI Applicator
Presenter
Presentation Notes
The second rotation of SAVI is to ensure tissue hasn’t become caught in the device as it’s been completely collapsed. Again, placement of the free hand on the breast may provide resistance for the turning and removal of the device. After the device has been removed, the incision site can be closed with either steri-strips or a sterile bandage.
Infection Management
• Prophylactic Antibiotics used at Physician discretion• Antibiotics at earliest sign of potential infection
a. More than expected erythema, swelling, pain, purulent drainage, fever
• If infection developsa. Treat with antibioticsb. Continue brachytherapy
• Antibioticsa. Keflex (if allergic, use Clindamycin)b. Ciprofloxacin if infection gram negative
Pallett, et. al., Arizona Oncology Services and Foundation for Cancer Research and Education, Phoenix, AZ; Seminars in Breast Disease 2007
Presenter
Presentation Notes
Infection management, although rare with SAVI, is vital. The use of prophylactic antibiotics is a controversial subject. A great article on this topic is provided in your Clinical Training Kit. I would like to point out one key thought from the article. If an infection develops, continue with radiation therapy while treating the infection. While the SAVI applicator is in place it allows drainage, and the drainage may help resolve the infection. Supporting Documentation: Infection Management in Patients Treated with Breast Brachytherapy
The SAVI Advantage
Sophisticated APBI technology– Treat the widest array of breast and cavity sizes– Offer to more women– Lower toxicity profile– Manage fewer infections, persistent seromas and skin
changes caused by higher doses of radiation
Education and training– #1 goal is for the entire team to become expert
Presenter
Presentation Notes
Allow me to summarize a few key benefits to offering SAVI as your 1st choice APBI applicator. You will find that you can offer 5-day treatment to more women by nearly eliminating skin distance and cavity size concerns. You should manage far fewer infections and persistent seromas. When you choose to work with Cianna you are entering in to a collaborative partnership whereby we promise to provide the most sophisticated APBI technology, education and training, and program development – all designed to support your practice while providing the very best in patient care. Our number one goal is to ensure the entire clinical team become SAVI experts AND that we help strengthen your program through community education.
Cianna Medical®, Inc.Experience the Difference
