Advances in Breast Reconstruction

Advanced Concepts in Breast Reconstruction:
Minimizing and Managing Complications
LifeCell Dinner Symposium
Denver, Colorado
Sunday, September 25th, 2011
Maximizing Technique to
Minimize Complications
Scot Bradley Glasberg, M.D.
Cosmetic and Reconstructive
Plastic Surgery
New York, New York
Important Information
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Dr. Glasberg is a speaker for LifeCell Corporation.
Some sections of this presentation which contain case studies and clinical reports are
based upon the surgeon’s clinical experience and research. Results may not be typical
and individual results may vary. Please refer to the Essential Prescriber Information for
product indications for use.
Users should read and understand all Instructions for Use, including essential
prescriber and safety information, prior to application of the product. For complete
safety information and complete instructions for the proper use of the SPY® Elite
System, please refer to the SPY® Elite System Operator’s Manual and SPY® Elite Kit
Instructions for Use. The SPY® Elite System is to be used under the direction of a
physician.
The surgical techniques described herein are suggested techniques for using LifeCell
Corporation Tissue Matrices. Proper surgical procedures and techniques are necessarily
the responsibility of the medical professional. Each surgeon must evaluate the
appropriateness of the technique based on his or her own medical training and
expertise.
The photographs contained in the presentations are the surgeon’s unless otherwise
indicated.
Trademarks used herein are trademarks of their respective owners.
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Consultant, Lifecell Corporation
Consultant, Mentor Corporation
◦ Principal Investigator:
x Mentor, Core Gel Silicone Implant Study
x Mentor, CPG Cohesive Gel Implants Studies
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Consultant, Gerson Lehrman Group
Consultant, Leerink Swann / Medacorp
Consultant, Healthcor Inc.
Interim Consultant, Ethicon / Johnson and
Johnson
Disclosures
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June 2004 – October
2007
Lenox Hill Hospital/
Englewood Hospital /
Beth Israel Medical
Center
126 reconstructions
96 patients
Average age = 44.5 y.o.
Average length of followup = 18.18 months
Biopsies taken at time
of exchange
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AlloDerm Results
3 expander extrusions
(2.4%)
0 major infections
0 mastectomy flap
necrosis
3 local infections /
cellulitis (2.4%)
16 seromas (12.7%)
2 hematomas (1.6%)
3 mild capsular
contractures (all in
previously radiated
patients) (2.4%)
[18 Localized redness /
inflammation (selflimited) (14.3%)]
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October 2007-present
Lenox Hill Hospital /
Beth Israel Medical
Center Englewood
Hospital
144 Reconstructions
90 Patients
Average age = 42.6 y.o.
Average length of followup = 14.4 months
Biopsies taken at
time of exchange
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2 expander extrusions /
loss * (1.4%)
0 major infections
2 mastectomy flap
necrosis (1.4%)
3 local infection / cellulitis
(2.1%)
2 seromas (1.4%)
0 hematomas
4 mild capsular
contractures (all in
previously irradiated
patients) (2.8%)
[18 localized redness /
inflammation (selflimited) (12.5%)]
Strattice (Pliable) Results
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12 breasts
previously radiated
(9.5% of breasts)
1 expander extrusion
(8.3%)
2 local infections /
cellulitis (16.6%)
0 mastectomy flap
necrosis
2 seromas (16.67%)
3 capsular
contractures (25%)
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21 breasts radiated
postoperatively
(16.67% of breasts)
1 expander extrusion
(4.8%)
1 local infections /
cellulitis (4.8%)
0 mastectomy flap
necrosis
2 seromas (9.5%)
0 capsular
contracture (0.0%)
AlloDerm Results – Radiation
(126 total breasts)
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16 breasts
previously radiated
(11.1% of breasts)
1 expander extrusion
(6.3%)
2 local infections /
cellulitis (12.5%)
1 mastectomy flap
necrosis
1 seromas (6.3%)
4 capsular
contractures
(25.0%)
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27 breasts radiated
postoperatively
(18.75% of breasts)
1 expander extrusion
(6.3%%)
1 local infections /
cellulitis (6.3%)
0 mastectomy flap
necrosis
0 seromas (0.0%)
0 capsular
contracture (0.0%)
Strattice Results – Radiation
(144 total breasts)
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Both preoperative and postoperative
radiation treatment adds statistically
significant increased risk of complications
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AlloDerm and Strattice may be used
effectively in two-stage breast
reconstructions involving radiation
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Surgeons should seriously consider
autogenous forms of reconstruction if
radiation was undertaken preoperatively or
known to be needed postoperatively
Discussion Points - Radiation
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Careful technical considerations
◦ Preoperatively
◦ Intraoperatively
◦ Postoperatively
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General vs. Technique-Specific
considerations
What Leads to Good Outcomes?
General Considerations
Endogenous versus Exogenous Risk Factors
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Tobacco and Alcohol use
Poor Nutrition
Obesity
Diabetes / hyperglycemia
Oxygen Saturation levels
Hypothermia
Remote Site Body Infection
Colonization with Microorganisms
Endogenous Risk Factors
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Smoking one cigarette lowers wound and
tissue PO2 by 30% for greater than 1 hour
Delays primary healing
Is associated with Surgical Site Infections
Encourage cease tobacco use at least one
month pre-surgery
◦ includes cigarettes, cigars, pipes, chewing tobacco
◦ And postoperatively as long as possible
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Jensen JA Arch Surg 126:1131-1134, 1991; CDC/HICPAC 1999 Prevention of SSI
Smoking
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Alcohol reduces effectiveness of immune
system, hampering:
◦ Neutrophils, Dendritic cells, Natural Killer (NK)
cells, B cell responses, general capacity to clear
infectious agents
◦ Barrier functions of skin, lung, and intestine
Waldschmidt TJ. Alcohol. 2008 Mar;42(2):137-42
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717 surgical patients observed for SSI or
pneumonia
◦ 14.8% of nondrinkers acquired infection
◦ 25% of those who consumed 109g -144g
alcohol/day
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News release, Hoboken, NJ: John Wiley & Sons, Inc, British Journal of Surgery, Oct 21,
2003
Alcohol
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Malnutrition
associated with
increased rate of
post-op
complications:
complications
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incision dehiscence
impaired wound healing
infection
delayed gastrointestinal
emptying
◦ recovery
ƒ Physical Examination
ƒ Usually assessed by
levels of:
–
–
–
–
albumin
prealbumin
transferrin
Total lymphocyte count
Klein JD.Spine 1996; 21(22): 2676-82;;Surgery: Basic Science and Clinical Evidence Ed.
Norton JA. Et. al. 2008 Springer Press. New York, NY
Nutrition
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Defined at >20% over ideal body weight
US adult elective surgery patient:
◦ 37% overweight
◦ 17% severely over-weight
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Weight alters
◦ hemostatic balance
◦ immune function
Obesity
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Interfere with epidermal regeneration and
collagen synthesis leaving the healing
incision more vulnerable to infection
Reduced resistance to infection
◦ system wide if given systemically
◦ locally if injected near the site of surgery
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Gradually taper use prior to surgery if
possible
Much forgotten intervention:
ÆHigh Dose Vitamin A
Steroids
y Macro and micro vascular damage
y Neutrophils at various levels of dysfunction
y May also have
◦ glycosylated hemoglobin
◦ impaired complement cascade
◦ impaired antibodies
x reduces antibody assisted cytotoxicity
x reduces opsonic potential and phagocytosis
y Control blood glucose levels preoperatively
◦ glucose below 200mg/dL (Some advise tight control below
100mg/dL)
◦ adjust intra-operatively for longer procedures
◦ continue at least 24 hours post-operatively
y Continuous Insulin better than intermittent insulin
◦ Multiple studies confirm lower rate of SSI
Diabetes
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Pre-existing Conditions of concern
◦ COPD, Smoker, Lung Cancer, Chronic Bronchitis etc.
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Reduced tissue oxygen resulting from obesity, diabetes,
heart disease, respiratory insufficiencies, iatrogenic tissue
ischemic events, hypothermia, tissue damage or other
hypoxic events reduce wound defenses and ability to heal
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O2 needed for:
ƒ macrophage mobility
ƒ neutrophil oxidative killing
ƒ collagen deposition (scar strength)
ƒ in-growth of granulation tissue
ƒ fighting anaerobic infections (e.g. Clostridia
Oxygen Saturation Levels
y Reduced risk of infection with supplemental
oxygen
Example:
500 colorectal procedures:
Two groups: Inspired oxygen during & two
hours post-surgery:
A. 30% inspired O2
B. 80% inspired O2 = 50% lower rate of
infection
Grief R Supplemental perioperative oxygen to reduce the incidence of wound infection.
NEJM. 2000; 342 (3):161-7
Supplemental Oxygen
y pre-surgery fasting
y relaxant-premedication
y prep solution cold and evaporating
y cold surfaces, thin gown
y high air turn-over filtration (windy)
y anesthesia reducing metabolism
y open wound vaporative heat
y cold irrigants and restorative fluids
Hypothermia – Heat loss?
Just 1.5°C below normal:
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increased wound infections (SSI)
decreases O2 tension in tissues
cardiac dysfunction
coagulopathy/increased blood loss
altered drug metabolism
delayed recovery of normothermia
increased mortality
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Mahoney CB. AANA Journal 1999;67(2): 155-164.; Sessler DI. Clinics of America 1994;12(3): 425-456;
Tammelin A. Infect Control Hosp Epidemiol 2001 Jun22(6): 338-346
Complications of Hypothermia
Invasive
Non-Invasive
Intravascular heating
catheter
Warmed bypass blood
Warmed irrigation
fluids
Hydrogel thermal pads
Hot forced air closely fitted
Hot water mattress/blanket
Hot air hose (bad practice)
Adjust room temperature
Infrared lamps or thermal
ceiling
Multiple layers of blankets
Plastic bags, paper drapes
Warming prep solutions
Operative Recommendation – Maintain Normothermia
>36
>96.8
Hypothermia – Reduce Risk
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Endogenous Sources – Patient
◦ Remote infection
◦ Normal skin flora
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Exogenous Sources
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Surgical Team
Environment
Non-sterile instruments
Organ / Tissue donations
Microbial Contaminants – where
come from?
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Do not remove hair unless absolutely
necessary to perform procedure
If removing, do so with clippers
immediately prior to surgery
Razor abrades skin
= niches for
microbial
colonization
Hair Removal – reduce risk
Hair removed by razor night before 5.6%
y Hair not removed or removed by depilatory
0.6%
y Razor >24 hours prior to surgery
>20.0%
y Razor < 24 hours prior to surgery
7.1%
y Razor immediately prior to surgery 3.1%
y Clippers night before surgery
4.0%
y Clippers right before surgery
1.8%
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1.) Seropian,R Am J Surg 1971;121;2511971;121;251-4 2.) Alexander JWArch Surg 1983;118(3) ;347;347-52; etal.
3.) Hamilton HW Can J Surg 1977;20:26971,2745;
Also
all
in
CDC
Guide
for
the
Prev
Of SSI
1977;20:269 71,274
SSI Related to Hair Removal
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Use an appropriate Skin Prep, antiseptic solution
◦ initial bacterial kill
◦ residual antimicrobial activity
◦ technique: concentric circle going outward *
◦ prep enough area to allow for enlarged
incision or drain insertion
◦ prep “dirty” areas last (e.g. umbilicus)
◦ let dry – do not wipe off
◦ do soak-up pooled solutions drained off patient
◦ do not drape before dry
OR Skin Preparation
MEAN REDUCTION IN SKIN BACTERIA
0%
Liquid Soap
Povidone-Iodine Liquid Soap
Chlorhexidine Detergent
90%
Povidone-Iodine Solution
Hexachlorophene Detergent
Isopropanol 70%
99%
Isopropanol 79% &
Chlorhexidine
99.9%
0
1
2
3
TIME AFTER DISINFECTION (HOURS)
Skin Prep Efficacy: Immediate and
Residual Kill
Proper ventilation
Lint-free gowns, towels, drapes
Appropriate attire – washed scrubs
Decrease staff traffic in OR – limit to those
involved in the surgery
y Clean and sterilize all equipment
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◦ Lights, loops etc.
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Duration of Surgery <6 hours
Minimize tissue trauma
DO NOT USE POWDERED GLOVES
Exogenous Sources – How to
Decrease?
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Amplified inflammation
Poor wound healing, scar formation
Granulomas
Blood clots
Adhesions
Infections
Debris in the Surgical Wound
Healthy Fibroblast Cells
Same cells after
suspension fluid
Touched with sterile
powdered glove
Technique-Specific
Considerations
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Malposition
Seroma
Infection
Flap Necrosis
Is Redness Alone an Infection/
Complication?
Potential Complications
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Proper Insetting of AlloDerm/Strattice is
key
‘Reinforcing the Pocket’ – 3 zones
◦ Release medial pectoral insertions
◦ Proper inframmamary fold placement
x Chest wall versus breast flap
◦ Lateral soft tissue support
Malposition
Inframmary Fold Control
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Subpectoral pocket raised
◦ Entire inferior border of pectoralis elevated
Intraoperative Technique
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AlloDerm sewn to either breast flap or chest wall
◦ Dermal side out
Intraoperative Technique
AlloDerm – Polarity / Orientation
Intraoperative / Inset
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Dermal matrices appear to be associated
with increased risk of seroma formation
◦ Possible explanations: repopulation, absorption
of basement membrane
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Associated axillary dissection
Increased use of cautery
Previous surgery – i.e. lumpectomy
Previous radiation therapy
Concomitant procedures – i.e.
capsulectomy
Seroma – Risk Factors
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Seroma prevention = proper drainage
and management
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Length of drainage
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Proper Placement of Drains
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Proper treatment of Seroma
Seroma
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At least one drain between breast flaps
and muscle/AlloDerm
◦ If any concern use two drains
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Expand intraoperatively
◦ Goal = Direct Apposition
x Risks: Too little -Æ seroma
Too much -Æ flap necrosis
Proper Drain Placement
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Comfortable, yet maximal expansion at time
of surgery – Direct Apposition
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Avoid undue stress on skin flap
Minimize dead space
Maximize adherence of AlloDerm to skin flap
Produce an immediate breast mound
Sufficient tension on the AlloDerm to
preserve breast shape:
◦ AlloDerm likely does not expand as compared to
the pectoralis muscle
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Closure with pectoralis deep to the incision is
preferred
How Much to Expand
Intraoperatively?
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Leave drains in place until <30cc./day
◦ May last 3-4 weeks
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If drainage does not stop by week #2
◦ Start expansion with drain in place
Drain Maintenance (algorithm)
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Common method – seroma aspiration
Proper Treatment of Seroma
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Closed system drainage
Proper Treatment of Seroma
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Use antibiotic irrigation for all procedures (1L NS
mixed with 100,000 units Bacitracin, 80 gms.
Gentamycin and 1 gm. Ancef)
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Single perioperative dose of Ancef or equivalent
(Surgical Care Improvement Project [SCIP]) within
one hour of surgery
◦ Excellent randomized prospective data
◦ Being advocated by multiple Departments of Health
and/or State Medical Boards
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Do not leave patients on antibiotics as long as drains
are in
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New Antibiotic Concept = ‘less is more’
Infection – Antibiotic Usage
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Just one key:
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Early operative intervention
Flap Necrosis
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‘Red Breast Syndrome’
Usually only represents inflammatory
response
Patients placed on oral antibiotics
◦ Probably not necessary
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Not all expanders must or should be
explanted
AlloDerm orientation appears important
Appears to correlate with cellular
repopulation – AlloDerm vs. Strattice
Breast Flap Redness
Good Technique = Good Result
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Refined techniques over prolonged period of time
Always prolonged soak (saline only)
Use antibiotic irrigation for all procedures (1L
NS mixed with 100,000 units Bacitracin, 80 gms.
Gentamycin and 1 gm. Ancef)
Breast surgeons rarely perform nipple-sparing
mastectomies – inoculation
When doing Nipple-Areola Sparing Mastectomy
cover nipple with Tegaderm
Never use powdered gloves – foreign nidus
One-touch technique
Cover the wound with Dermabond - sealed
TECHNICAL PEARLS
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SCIP (Surgical Care Improvement Project)
Antibiotic Protocol – started 1/08
◦ Single perioperative dose
Form fitting surgical bra
Biopatch – drain insertion site
Surgeon does the surgery – less variability
Prep used – not betadine, chlorhexidine / alcohol
mix (Chloraprep)
Wipe wound with alcohol
Definition of infection
◦ ‘Red Breast Syndrome’
Technical Pearls – Few More
Competitive
Products
‘The Truth is Out There’
y Regenerative
products
◦ ‘It’s all about the science’
y Any
clinical data?
◦ Has tissue been used in humans?
◦ Are there any animal studies?
xWhat species?
Basic Concepts / Questions
y How
is tissue processed?
y Does
process lead to cross-linking
of collagen?
◦ Prevents cellular ingrowth
Basic Concepts (continued)
y What
does ‘safety’ (Sterility)
really mean?
◦ Human Tissue Standards
x>1,200,000 pieces of AlloDerm®
implanted without any issues
◦ 510k – terminally sterilized
xViral inactivation
xDecreased bioburden
y Histology
◦ “Show me the money”
Basic Concepts (continued)
Impact of Processing on Matrix Characteristics:
Structure
Skin
Intact Collagen
Cross-linking
Chemical-Induced
Cells
Loss of Collagen
Confidential
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Pre-Implant Histology
Preservation of the Matrix
Preimplant Histology
Competitive Product
Explant Histology
AlloDerm Æ Regeneration
Explant Histology
Competitive Product (cross-linked)
Explant Histology
Competitive Product (non cross-linked)
Just One More!
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Raise your hand and a microphone will be
passed to you
Please state your name and where you
are from
Questions
Thank You